Funded Projects

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Project # Sort descending	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s)	Investigator(s)	Location(s)	Year Awarded
1R43HD107727-01A1	Novel Approach to Personalize and Monitor Therapeutic Training At Home in Chronic Pelvic Pain Management	Cross-Cutting Research	Small Business Programs	NICHD	Hillmed, Inc.	DIAS, NICHOLAS	Katy, TX	2022
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed) NOFO Number: RFA-NS-20-011 Summary: Chronic pelvic pain is a debilitating condition that negatively affects the social and sexual quality of life for up to 20% of American women. Pelvic floor muscle (PFM) pain is caused by many factors, as well as by incorrect posture and excessive sensitization of the peripheral nervous system. This project will introduce a prototype of the Chronic Pelvic Pain (CPP) HomeTrainer that monitors, quantitatively and in real time, both PFM activation capacity and muscle interactions between the PFM and hip/trunk muscles and adapts the PFM training to the user’s needs in their own home. The proposed CPP HomeTrainer offers biofeedback to aid myofascial physical therapy and movement pattern training by tailoring the protocol to specifically correct interactions between the PFM and problematic hip/trunk muscles.
1R43NR017575-01A1	Using Virtual Reality Psychological Therapy to Develop a Non-Opioid Chronic Pain Therapy	Cross-Cutting Research	Small Business Programs	NINR	COGNIFISENSE, INC.	BAEUERLE, TASSILO; CEKO, MARTA ; WEBSTER, LYNN	Sunnyvale, CA	2019
NOFO Title: PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]) NOFO Number: PA-17-302 Summary: Chronic pain affects over 100 million Americans, costing society about $600 billion annually. Despite numerous pharmacological and non-pharmacological therapies, over 50% of chronic pain sufferers feel little control over their pain. CognifiSense has developed a patent-pending Virtual Reality Psychological Therapy (VRPT), which is designed to create lasting reduction of chronic pain by addressing the maladaptive learning processes driving pain chronification. VRPT is an experiential learning system, which provides the brain a new set of signals that teaches it that the pain is not as bad as it perceived and that it has greater control over the pain than it perceived. VRPT combines the immersive power and the ability to individualize the therapy of Virtual Reality with well-researched principles of self-distancing, self-efficacy, and extinction to retrain the brain. The goal of this study is to determine the clinical feasibility of VRPT in achieving a lasting reduction of chronic pain, establish brain mechanisms associated with treatment response, and collect comprehensive user feedback to enable further refinement of the current product prototype. CognifiSense's VRPT has the potential to be a significant clinical and business opportunity in the treatment of chronic pain.
1R43NS110117-01	Development of a novel anti-migraine therapeutics	Cross-Cutting Research	Small Business Programs	NINDS	ADEPTHERA, LLC	HSU, SHEAU-YU TEDDY	Palo Alto, CA	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: New approaches that can effectively ameliorate acute and chronic migraine pain are urgently needed. Due to its critical roles in inducing migraine pain, CGRP and its receptor complex, the calcitonin receptor-like receptor (CLR) and receptor activity-modifying protein 1 (RAMP1) have been targeted for migraine treatment. A new strategy for targeting the CGRP-mediated signaling pathway is needed to meet the medical need of migraine patients. The team developed a group of long-acting CGRP/RAMP1-specific peptide super-antagonists that form gels in situ in aqueous solution. Based on this exciting finding, the investigators propose to develop and identify the most potent antagonistic analog candidates (Aim 1), and characterize the pharmacokinetics of gel depots made of the selected candidates in vivo (Aim 2). This feasibility study is needed to explore the translational potential of these newly invented super-antagonists for the treatment of chronic migraine in combination with conventional migraine agents.
1R43NS112088-01A1	Repression of Sodium Channels via a Gene Therapy for Treatment of Chronic Neuropathic Pain	Cross-Cutting Research	Small Business Programs	NINDS	NAVEGA THERAPEUTICS, INC.	MORENO, ANA MARIA; ALEMAN GUILLEN, FERNANDO	San Diego, CA	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: Voltage-gated sodium channels are responsible for the transmission of pain signals. Nine genes have been identified, each having unique properties and tissue distribution patterns. Genetic studies have correlated a hereditary loss-of-function mutation in one human Na+ channel isoform – ?Na?V?1.7 – with a rare genetic disorder known as Congenital Insensitivity to Pain (CIP). Individuals with CIP are not able to feel pain without any significant secondary alteration. Thus, selective inhibition of ?Na?V?1.7 in normal humans could recapitulate the phenotype of CIP. This research team developed a non-permanent gene therapy to target pain that is non-addictive (because it targets a non-opioid pathway), highly specific (only targeting the gene of interest), and long-term lasting (around 3 weeks in preliminary assays in mice). During this Phase I , the team will 1) test additional pain targets ?in vitro?, and 2) evaluate the new targets ?in vivo ?in mice models of inflammatory and neuropathic pain.
1R43NS113726-01	Pharmacokinetic and toxicology studies of AYX2, a transcription factor decoy, non-opioid, disease modifying drug candidate for the long-term treatment of chronic pain	Cross-Cutting Research	Small Business Programs	NINDS	ADYNXX, INC.	MAMET, JULIEN	San Francisco, CA	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: Chronic focal neuropathic pain, which includes pain etiologies such as radiculopathy and radiculitis, focal peripheral neuropathies, and low back pain, affects as many as 25 million patients annually in the United States. Chronic focal neuropathic pain is maintained by genome-wide transcription regulation in the dorsal root ganglia (DRG) / spinal cord network. The transcription factors driving this regulation constitute a promising class of targets with the potential to alter the course of pain with a single treatment. DNA decoys are oligonucleotides that specifically inhibit the activity of certain transcription factors. AYX2 binds and inhibits Krüppel-like transcription factors (KLF) in the DRG-spinal cord. The goal of this Phase 1 proposal is to advance AYX2 toward an IND submission, allowing for human clinical trials. We propose in Aim 1 to characterize AYX2 pharmacokinetics in the cerebrospinal fluid and plasma and its distribution in the DRG, spinal cord and brain following an IT injection. With this information, AYX2 will be tested in a panel of complementary toxicology studies in Aim 2 to allow for final IND-enabling studies, supported by Phase 2 of the grant. This research will accelerate development of AYX2 as a novel drug candidate for the non-opioid treatment of pain.
1R43NS115294-01	Developing EXP-1801 as an imaging agent to quantify pain and analgesia	Cross-Cutting Research	Small Business Programs	NINDS	EXPESICOR, INC.	NORWOOD, BRAXTON	Kalispell, MT	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: The use of a pain imaging technology would allow for objective efficacy data (both pre-clinically and in clinical trials), and reduce costs by enabling smaller sample sizes due to more homogeneous populations; i.e. with a particular “pain signal,” and more accurate measurement of analgesic effects. This research team recently invented a novel positron emission tomography (PET) imaging agent as a tool to address these issues in pain care and therapy development. Although the ability of PET to detect pathological changes for (early) disease detection is widely used in cancer and neurological diseases, it has not yet been used for pain indications. The goals of this project are: 1) to change the evaluation of (experimental) pain therapies, and 2) the standard of care in pain assessment through molecular imaging. The proposed study is designed to determine the feasibility of our imaging agent to objectively measure pain in rodents. This will set the stage for a Phase II study that further develops this agent into a tool for quantifying pain/analgesia.
1R43NS115312-01	Long-acting ghrelin for neuropathy	Cross-Cutting Research	Small Business Programs	NINDS	EXTEND BIOSCIENCES, INC.	SOLIMAN, TARIK	Newton, MA	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: There is a need for safe, effective, well- tolerated drugs to treat painful neuropathy by halting or reversing the underlying pathology of the disease. One promising approach to treating painful neuropathy without opioids is the use of ghrelin, a 28-amino acid acylated peptide hormone. However, it has a short half-life and must be delivered via a constant intravenous infusion to have a therapeutic effect. Extend Biosciences' D-VITylation platform technology is truly enabling for small peptide-based therapeutics that are rapidly cleared from the bloodstream by renal filtration. The platform harnesses the naturally long half-life of vitamin D and its dedicated binding protein, VDBP. When the vitamin D molecule is conjugated to a biological therapeutic, it dramatically improves the half-life and bioavailability of the drug. Use of the technology should also allow the drug to be self-administered by subcutaneous injection. This would be of significant benefit to patients. In this project, the team will test the efficacy of EXT405 in a cell-based model of neuropathy as well as in animal models of CIPN and diabetes- induced neuropathy.
1R43NS119087-01A1	Evaluating the Blood-Brain Barrier Bioavailability and in vivo Efficacy Potential of a Novel TAK1 Inhibitor Targeting Chronic Pain	Cross-Cutting Research	Small Business Programs	NINDS	EYDIS BIO, INC.	SCARNEO, SCOTT (contact); HAYSTEAD, TIMOTHY A	Durham, NC	2021
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed) NOFO Number: NS-20-011 Summary: Over-the-counter medicines such as non-steroidal anti-inflammatory drugs are ineffective for treating severe chronic pain and may have serious side effects from continued use, which limits treatment options. A kinase (an enzyme whose activity targets a specific molecule) called TAK1 is involved in the chronic pain process. This research will develop a molecule previously shown to be effective in a model of inflammatory pain that also inhibits TAK1. A main goal will be to determine if this inhibitor (takinib analog HS-276) can cross the blood-brain barrier and, if successful, pursue FDA Investigative New Drug-enabling safety studies leading to a Phase I clinical trial and a potential new chronic pain treatment.
1R43NS120335-01	Closed-Loop Micromagnetic Neuromodulation as a Non-Opioid Treatment for Neuropathic Pain	Cross-Cutting Research	Small Business Programs	NINDS	QUANTUM NANOSTIM	REILLY, THOMAS	Treasure Island, FL	2021
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed) NOFO Number: RFA-NS-20-011 Summary: Spinal cord stimulation (SCS) has been shown to provide effective relief for most people with chronic pain and eliminated the need for opioid therapy in more than half of those treated. However, traditional SCS approaches have encountered problems when glial cells coat the stimulation electrodes that distance the device from targeted neurons. This project will develop a novel hybrid Closed Loop Omnidirectional Neuromodulation with Electromagnetic fields (CLONE) system that is combined with magnetic-based stimulation to overcome glial coating of SCS electrodes, better target neurons in dorsal spine tissue, which may lead to better treatment of chronic neuropathic neck and low back pain.
1R43NS120410-01A1	Optimization of a Gene Therapy for Chronic Pain in Human DRGs	Cross-Cutting Research	Small Business Programs	NINDS	NAVEGA THERAPEUTICS, INC.	MORENO, ANA MARIA (contact); ALEMAN GUILLEN, FERNANDO	La Jolla, CA	2021
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed) NOFO Number: NS-20-011 Summary: To avoid the reliance on opioids for treatment of pain, researchers are investigating alternative approaches to disrupt the transmission of pain signals by specialized neurons in the body, such as dorsal root ganglion neurons in the spinal cord. Molecules called voltage-gated sodium channels that are located in the membranes of dorsal root ganglion neurons are essential for transmission of the pain signals. People carrying a specific variant of these channels, NaV1.7, are insensitive to pain; therefore, strategies to block this particular channel might help in the development of non-addictive pain treatment approaches. Navega Therapeutics is developing an innovative gene therapy that specifically targets NaV1.7. Using studies in human cell lines, they will identify the best designs to then test this gene therapy approach in human dorsal root ganglion neurons.
1R43NS120617-01A1	Chemokine-receptor profiling for painful diabetic neuropathy in biological samples from human clinical trials	Cross-Cutting Research	Small Business Programs	NINDS	PLUMERIA THERAPEUTICS, INC.	RICHARDSON, THOMAS P (contact); WANG, YIPING	Plainsboro, NJ	2021
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed) NOFO Number: RFA-NS-20-011 Summary: Chronic pain is a major healthcare burden. However, the types and underlying mechanisms of pain vary greatly, as do patient responses to currently available pain medications. Inflammation in the nervous system (neuroinflammation) is involved in several types of pain, and targeting key molecules involved in neuroinflammation is therefore a promising treatment approach. The chemokine receptor system, a complex network of more than 20 different receptors and more than 80 molecules that bind to these receptors, has a central role in neuroinflammation. Researchers do not yet fully understand the functioning of this network and how specific receptors vary in different chronic pain conditions. Therefore, this project aims to further characterize the expression of one specific receptor, using samples collected from participants in clinical trials evaluating a compound that interferes with the receptor’s function. This information should allow researchers to classify pain patients and identify those most likely to benefit from a treatment with compounds targeting the receptor.
1R43NS124421-01A1	Development of Nav1.7 Monoclonal Antibodies for Treating Pain	Cross-Cutting Research	Small Business Programs	NINDS	INTEGRAL MOLECULAR	RUCKER, JOSEPH BENJAMIN	Philadelphia, PA	2021
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed) NOFO Number: RFA-NS-20-011 Summary: Many current pain relief treatments rely on use of opioid drugs. This research is conducting preclinical development on a non-addictive, non-opioid therapeutic that uses antibodies to target the sodium channel Nav1.7. This channel is known to be one of the primary routes for generating pain signals – thus it is a target for reducing pain. The antibody approach offers potential for greater specificity than small molecule approaches, potentially resulting in fewer side effects.
1R43NS125643-01	Development of an intranasal, direct to nerve treatment for headache disorders	Cross-Cutting Research	Small Business Programs	NINDS	Olfax, LLC	BECKWITH, JONATHAN G (contact); COOK, JASON T	Asheville, NC	2022
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed) NOFO Number: RFA-NS-20-011 Summary: About 14% of U.S. adults report experiencing migraine symptoms within any given 3-month period, making it the second most disabling illness in the world. Nonspecific pain medications used in migraine (e.g., acetaminophen, nonsteroidal inflammatory drugs, opioids) are often not effective for severe migraine symptoms or cause significant adverse effects. A research team of migraine care specialists, device and drug developers, and clinical research specialists has created a technology for accurately delivering self-administered migraine medication to the upper nasal cavity. The technology enables development of a self-administered therapy to provide rapid pain relief without harsh and addictive side effects of existing migraine medications. This project will establish efficacy and evaluate commercial design feasibility for this treatment.
1R44AR074820-01A1	A phenotypic screen for osteoarthritic pain therapeutics using all-optical electrophysiology	Cross-Cutting Research	Small Business Programs	NIAMS	QUELL TX, INC.	LIU, PIN; MCMANUS, OWEN B	Cambridge, MA	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: Quell Therapeutics uses the Optopatch platform for making all-optical electrophysiology measurements in neurons at a throughput sufficient for phenotypic screening. Using engineered optogenetic proteins, blue and red light can be used to stimulate and record neuronal activity, respectively. Custom microscopes enable electrophysiology recordings from 100’s of individual neurons in parallel with high sensitivity and temporal resolution, a capability currently not available with any other platform screening technology. Here, researchers combine the Optopatch platform with an in vitro model of chronic pain, where dorsal root ganglion (DRG) sensory neurons are bathed in a mixture of inflammatory mediators found in the joints of osteoarthritis patients. The neurons treated with the inflammatory mixture become hyperexcitable, mimicking the anticipated cellular pain response. Investigators calculate the functional phenotype of arthritis pain, which captures the difference in action potential shape and firing rate in response to diverse stimuli. The team will screen for small molecule compounds that reverse the pain phenotype while minimizing perturbation of neuronal behavior orthogonal to the pain phenotype, the in vitro “side effects.” The highest ranking compounds will be chemically optimized and their pharmacokinetic, drug metabolism, and in vivo efficacy will be characterized. The goal is to advance therapeutic discovery for pain, which may ultimately help relieve the US opioid crisis.
1R44AR076885-01	Enhancing Physical Therapy: Noninvasive Brain Stimulation System for Treating Carpal Tunnel Syndrome	Cross-Cutting Research	Small Business Programs	NIAMS	HIGHLAND INSTRUMENTS, INC.	WAGNER, TIMOTHY ANDREW; DIPIETRO, LAURA	Cambridge, MA	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) NOFO Number: PA-18-573 Summary: Non-Invasive Brain Stimulation (NIBS) has been successfully applied for the treatment of chronic pain (CP) in some disease states, where treatment induced changes in brain activity revert maladaptive plasticity associated with the perception/sensation of CP [25-28]. However, the most common NIBS methods, e.g., transcranial direct current stimulation, have shown limited, if any, efficacy in treating neuropathic pain. It has been postulated that limitations in conventional NIBS techniques’ focality, penetration, and targeting control limit their therapeutic efficacy . Electrosonic Stimulation (ESStim™) is an improved NIBS modality that overcomes the limitations of other technologies by combining independently controlled electromagnetic and ultrasonic fields to focus and boost stimulation currents via tuned electromechanical coupling in neural tissue . This proposal is focused on evaluating whether our noninvasive ESStim system can effectively treat CP in carpal tunnel syndrome (CTS), both as a lone treatment and in conjunction with physical therapy (PT). Investigators hypothesize ESStim can be provided synergistically with PT, as both can encourage plasticity-dependent changes which could maximally improve a CTS patient’s pain free mobility. In parallel with the CTS treatments, the team will build multivariate linear and generalized linear regression models to predict the CTS patient outcomes related to pain, physical function, and psychosocial assessments as a function of baseline disease characteristics. The computational work will be used to develop an optimized CTS ESStim dosing model.
1R44CA271904-01A1	Novel Biologic to Treat Chemotherapy-Induced Neuropathic Pain	Cross-Cutting Research	Small Business Programs	NCI	RAFT PHARMACEUTICALS, LLC	KOGAN, YAKOV	San Diego, CA	2022
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed) NOFO Number: RFA-NS-20-011 Summary: Some chemotherapy treatments damage nerves outside the brain and spinal cord. This condition, chemotherapy-induced peripheral neuropathy, involves tingling, burning, weakness, or numbness in hands and/or feet and affects nearly 70% of cancer patients receiving chemotherapy. Common pain medications, including opioids, can relieve pain for short intervals but are not suitable for long-term therapy. This project will conduct studies to investigate the safety and tolerability of a novel strategy to treat neuropathic pain: modifying the activity of the dorsal root ganglia, which are nerve cells in the spinal cord that communicate pain signals to and from the brain.
1R44GM140795-01A1	Non-Opioid Post-Operative Pain Management Using Bupivacaine-loaded Poly(ester urea) Mesh	Cross-Cutting Research	Small Business Programs	NIGMS	21MEDTECH, LLC	ALFARO, ARTHUR	Durham, NC	2021
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed) NOFO Number: RFA-NS-20-011 Summary: There is an urgent need for non-opioid post-operative pain management solutions. This research is developing a naturally absorbable polymer film that can release controlled amounts of the non-opioid analgesic bupivacaine – aiming to manage pain for several days following surgery. Project objectives are to optimize the timing of drug release, develop manufacturing standards, determine effective dosage for preserving motor function, and determine safety and efficacy in mouse models of neuropathic pain. Continued development of this film delivery system may lead to a new, non-opioid therapeutic strategy that could be combined with local anesthesia for up to 4 days after surgery to reduce or potentially eliminate opioids use.
1R44HD107822-01	A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management	Cross-Cutting Research	Small Business Programs	NICHD	HILLMED, INC.	DIAS, NICHOLAS	Katy, TX	2021
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required) NOFO Number: RFA-NS-20-010 Summary: Chronic pelvic pain affects social and sexual quality of life in up to 20% of women in the United States. It is often managed with physical therapy approaches, but when these measures fail, injection therapies may be indicated. These include injection of botulinum neurotoxin, which leads to muscle relaxation in the pelvic floor and thus pain relief. However, botulinum neurotoxin has dose-dependent side effects and is expensive. Therefore, a precision injection technique to administer botulinum neurotoxin so that it remains effective while minimizing adverse effects and costs is needed. Hillmed Inc. has developed a technique to assess the pelvic floor and choose the optimal injection site, which has improved treatment outcome in initial analyses. They are now aiming to develop a commercializable, personalized precision injection medical device for botulinum toxin and software package that will enable clinicians to optimize botulinum neurotoxin injection. They will then assess the system’s efficacy in a clinical trial of women with chronic pelvic pain and healthy women.
1R44NS113740-01	An Instrument to Assess the Functional Impact of Chronic Pain	Cross-Cutting Research	Small Business Programs	NINDS	BARRON ASSOCIATES, INC.	CLARK, BRIAN R	Charlottesville, VA	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: The proposed Fast Track SBIR effort will develop and validate the reliable, low-cost KnowPain instrument. KnowPain will objectively and quantitatively assess the functional impact of chronic pain using measures derived from six degrees-of-freedom motion, heart rate, skin surface temperature, and skin conductivity collected via a specially designed, ergonomic wrist-worn biometric sensing instrument. The new assessment instrument will apply advanced psychometric methods to both physiologic and kinematic data to provide precise scores for functional impairment due to chronic pain. The assessment results will be presented to the clinician in an easy-to-understand report and will include longitudinal results, confidence estimates, and normative data to enable comparisons both within and between patients. The system will include provision to interface with electronic medical records. Accurate functional assessment is a crucial component in the effective treatment of chronic pain. The proposed approach will supplement existing methods for assessing patient function by providing novel and highly complementary information for a more complete (and often unobserved) picture of the impact of chronic pain on patient function. KnowPain measures will provide important data on the practical consequences of pain and on treatment efficacy.
1R44NS113749-01	Micronized salsalate in a parenteral formulation is a safe and effective analgesic for acute postoperative pain management	Cross-Cutting Research	Small Business Programs	NINDS	RH NANOPHARMACUETICALS L.L.C.	ROSS, JOEL STEVEN	Monmouth Beach, NJ	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: There is an unmet need for an effective parenteral/oral analgesic for acute post- operative pain management without the risks of opioid addiction. Salsalate, a dimer or salicylic acid, is currently available in oral dosage for the treatment of osteoarthritis and rheumatoid arthritis. Salsalate works at multiple levels to target multiple steps along the surgical pain pathway. Salsalate through its active metabolite, salicylic acid (SA), reduces NF-?B activation via IKK-kinase beta inhibition, and has no direct binding to cyclooxygenase 1 (Cox-1); therefore, does not affect function of platelets, resulting in a safer hematological and gastrointestinal safety profile. RH Nano proposes a plan for manufacturing and pre- clinical testing of parenteral M-salsalate in two animal models to assess the efficacy and safety in the treatment of acute postoperative pain management. In this proposal, the team will develop the optimal formulation under strict Chemistry Manufacturing and Control guidelines. In Phase II, the team proposes to conduct the pharmacokinetics and toxicology studies of M-salsalate in two species of animals (rodent and non-rodent). Additionally, the project will use an animal pain model for preclinical efficacy studies, and an in vivo Receptor Occupancy assay in animal brain tissues to assess the opioid sparing properties of M-salsalate.
1R44NS115196-01	A single dose long-acting non-addictive polymer conjugate formulation of buprenorphine that provides immediate and prolonged analgesia for post-operative pain	Cross-Cutting Research	Small Business Programs	NINDS	SERINA THERAPEUTICS, INC.	VIEGAS, TACEY XAVIER; MOREADITH, RANDALL W	Huntsville, AL	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: SER-227 is a long-acting polymer pro-drug of buprenorphine that is being developed to treat post- operative pain following major surgeries such as bunionectomy, abdominoplasty, thoracotomy and knee and hip surgery. The ultimate goal is to demonstrate that SER-227 can be manufactured and tested preclinically to show that it is safe for use in a Phase I clinical study. Aims include 1.SER-227 chemistry and process optimization to generate a technical package, 2. SER-227 manufactured under current Good Manufacturing Practices, 3. Evaluated in formal toxicology studies in rodent and non-rodent animals so that justifications can be made to support a ‘first-in-man’ study, and 4. Submission of an Investigational New Drug application (IND) along with a Phase I clinical protocol in normal volunteers to measure the safety, tolerability and pharmacokinetics of buprenorphine that is released from SER-227.
1R44NS119036-01	Development of a novel analgesic for mixed inflammatory and neuropathic pain states	Cross-Cutting Research	Small Business Programs	NINDS	ANABIOS CORPORATION	GHETTI, ANDREA	San Diego, CA	2021
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed) NOFO Number: RFA-NS-20-011 Summary: As prescription opioid drug abuse and overdose-related deaths continue to skyrocket in the United States, the need for new and more effective non-addictive pain drugs to treat chronic pain remains critical. This research is conducting studies in animal models of a small molecule that has high potential to treat chronic pain conditions associated with neuropathy and/or inflammation. The goal of this project is to conduct dosing and other studies leading up to an animal model study of the potential drug in a toxicology study for 28 days. Results may lead to Investigative New Drug regulatory clearance to begin clinical studies to validate the potential drug’s efficacy and safety.
1R44NS125745-01A1	Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)	Cross-Cutting Research	Small Business Programs	NINDS	EVON MEDICS, LLC	NWAOKOBIA, CHARLES CHIEDU (contact); NWULIA, EVARISTUS A	Elkridge, MD	2022
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required) NOFO Number: RFA-NS-20-010 Summary: Research shows that individuals with chronic pain may experience brain changes that contribute to anxiety, depression, and cognitive impairment. This project will test a user-friendly, home-based device to treat chronic pain. The device stimulates the brain through olfactory training: repetitive daily stimulation with specific smells. The research will optimize a treatment approach and test the device in a clinical study.
1R61AG081034-01	Addressing the Chronic Pain Epidemic among Older Adults in Underserved Community Center; The GetActive+ Study	Clinical Research in Pain Management	Advancing Health Equity in Pain Management	NIA	Massachusetts General Hospital	VRANCEANU, ANA-MARIA (contact); RITCHIE, CHRISTINE S	Boston, MA	2022
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required) NOFO Number: NS22-002 Summary: This research project will include focus group interviews with clinicians, patients, medical interpreters, and healthcare administrators to identify barriers and facilitators to administering the GetActive+ intervention in a group visit at a clinic for older adults with chronic pain, to inform development of a therapy manual. The project will then test the GetActive+ intervention for changes in physical function immediately post-intervention and after 6 months, as well as for changes in pain, sleep, depression, and anxiety at both time points. This research will also assess feasibility, acceptability, fidelity, and adoption of the intervention with patients, providers, and healthcare staff.
1R61AT012185-01	MRI-Based Quantitative Characterization of Impaired Myofascial Interface Properties in Myofascial Pain Syndrome	Clinical Research in Pain Management	Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions	NCCIH	MAYO CLINIC ROCHESTER	YIN, ZIYING (contact); BAUER, BRENT A	Rochester, MN	2022
NOFO Title: HEAL Initiative: Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management NOFO Number: RFA-AT-22-003 Summary: Pain in the muscles and surrounding connective tissue (myofascial pain) is a significant health concern affecting hundreds of millions of Americans. Understanding and managing myofascial pain has been limited due to a lack of tools to help clinicians diagnose and treat this disorder. While past efforts to understand myofascial pain have focused on impairments in how connective tissues connect to other tissues in the body, this project will use a new imaging technique to study myofascial tissue physical properties, including how they move in the body and their structural stiffness. This research will identify an imaging biomarker to be used in a randomized controlled clinical trial to predict patient responses to a myofascial pain treatment.