Project Grant R44NS086229

This $570,362 Project Grant award from the National Institute of Neurological Disorders and Stroke (NINDS) under the Extramural Research Programs in the Neurosciences and Neurological Disorders (CFDA 93.853) is funding research to evaluate the disease-modifying potential of dimethyl fumarate (DMF) for preventing and treating pharmacoresistant epilepsy. The research aims to determine the pharmacokinetic/pharmacodynamic relationship of DMF, demonstrate stable blood and brain levels using an...

The National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), awarded a $267,000 Project Grant (R21DA058120) to The Children's Hospital Corporation (Boston Children's Hospital) to develop depot formulations for on-demand, tamper- and diversion-proof delivery of opioids. The goal is to create injectable polymer-based depot formulations that are covalently bonded to opioids via photolabile linkers, which would make the formulations resistant to...

The National Institute of Neurological Disorders and Stroke (NINDS) awarded a $9,296,510 Cooperative Agreement under the Extramural Research Programs in the Neurosciences and Neurological Disorders (CFDA 93.853) to the Rector & Visitors of the University of Virginia. The funding supports a Phase III clinical trial to evaluate the efficacy of adding ketamine therapy to the standard treatment of levetiracetam for established status epilepticus. The trial will test whether the ketamine add-on...

This Project Grant award from the National Institute of Neurological Disorders and Stroke (NINDS), under the Extramural Research Programs in the Neurosciences and Neurological Disorders (CFDA 93.853) program, provides $323,001.00 to Axonis Therapeutics, Inc. to develop an oral KCC2 potentiator compound, AXN-027, as a novel anti-epileptic drug for mesial temporal lobe epilepsy (MTLE). The key products and services to be delivered include using a mouse model of MTLE to investigate the anti-seizure...

The National Institute on Drug Abuse (NIDA), under the federal Drug Use and Addiction Research Programs (CFDA 93.279), has awarded a $23,579,701 Cooperative Agreement to Ensysce Biosciences, Inc. to support the clinical development of PF614-MPAR, an opioid product with oral overdose protection. The key objectives of this project are to continue the clinical development of PF614-MPAR, a combination product of a trypsin-activated abuse protection (TAAP) oxycodone prodrug and a trypsin inhibitor...

The National Institute on Drug Abuse (NIDA) awarded Rebel Medicine Inc. a $591,842 Project Grant under the Drug Use and Addiction Research Programs (CFDA 93.279) to develop an extended-duration injectable local anesthetic formulation as an alternative to opioid-based pain medications. The project aims to demonstrate the safety and efficacy of a proprietary lipophilic bupivacaine oleogel formulation that can provide up to 7 days of sustained pain relief from a single injection, mitigating the...

This Project Grant award, with a total funding of $3,002,873.00, was awarded by the Defense Health Agency under the Military Medical Research and Development program (CFDA 12.420). The purpose of the grant is to conduct a randomized clinical trial titled "ASPIRED: ALLEVIATING SUICIDALITY BY COMBINING PSYCHOTHERAPY AND IM KETAMINE FOR RAPID TREATMENT IN THE EMERGENCY DEPARTMENT". The University of Texas Health Science Center at San Antonio (UTHSCSA) is the prime grantee for this...

This Project Grant award from the National Institute of Neurological Disorders and Stroke (NINDS), under the Extramural Research Programs in the Neurosciences and Neurological Disorders (CFDA 93.853) program, provides $391,903 to the Allen Institute to develop an oligonucleotide therapeutic for Dravet syndrome. The goal is to create an antisense oligonucleotide (ASO) that upregulates the Nav1.1 protein, which is encoded by the SCN1A gene and deficient in Dravet syndrome patients. The project...

The National Institutes of Health (NIH) awarded a $2,507,286 Project Grant under the Trans-NIH Research Support program (CFDA 93.310) to investigate therapies for Down Syndrome Regression Disorder (DSRD). The 3-year grant, which commenced on September 1, 2024, supports a comparative clinical trial evaluating the safety and efficacy of three potential DSRD treatments: the benzodiazepine lorazepam, intravenous immunoglobulin (IVIG), and the JAK inhibitor tofacitinib. The project aims to advance...

This Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $319,000 to Sano Healthcare Consultants, LLC for the development of a novel liquid methadone dispensing device and smart container system. The project aims to address key barriers in accessing medication for opioid use disorder (MOUD) by creating a low-cost, single-device solution that enables remote supervised use, telehealth, and behavioral...