Recro Pharma, a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges in small molecule therapeutic development, and BioCorRx, a developer and provider of advanced solutions in the treatment of substance use disorders, announced the expansion of the companies’ ongoing relationship with the signing of a new development and manufacturing agreement. Under terms of the new agreement, Recro will provide analytical validation services and cGMP manufacturing of registrational batches of BICX104 to support BioCorRx’s potential filing of a New Drug Application (NDA) for BICX104 with the FDA.
BICX104 is a biodegradable, long-acting subcutaneous pellet of naltrexone for the treatment of opioid use disorder (OUD) being developed under BioCorRx Pharmaceuticals, Inc., BioCorRx’s controlled R&D subsidiary. BioCorRx has received clearance from the FDA to proceed to human trials for BICX104 and expects to initiate the first-in-human clinical trial of the drug candidate as soon as scheduling permits. The project has been funded in large part by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under award number UG3DA047925 and is a result of BioCorRx’s application under RFA DA-19-002, Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional).
“The exceptional service and support provided through our ongoing CDMO relationship have been critical to BioCorRx’s successful advancement of our implantable naltrexone program. Recro’s recent acquisition of IriSys further bolsters our confidence in our CDMO partnership as we move BICX104 into the clinical stage and a step closer to market for patients battling opioid use disorder, as well as alcohol use disorder (AUD),” said Brady Granier, president and director of BioCorRx, Inc., and chief executive officer of BioCorRx Pharmaceuticals, Inc.
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