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Recro and BioCorRx expand partnership for OUD treatment

10 Sep 2021

The CDMO, through its recent acquisition of IsiSys, will help to advance BICX104 toward first-in-human clinical trials

Recro Pharma and BioCorRx have expanded their ongoing partnership by signing a new development and manufacturing agreement concerning the latter's potential treatment for opioid use disorder (OUD).

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.

This new agreement expands the previously signed Master Services Agreement (MSA) between BioCorRx and IriSys in 2019, the San Diego-based CDMO that was acquired by Recro only last month. Speaking of the transaction, Brady Granier, president and director of BioCorRx, and CEO of BioCorRx Pharmaceuticals, said it "bolsters our confidence in our CDMO partnership".

Under the initial MSA, IriSys provided CDMO services supporting BICX102, the preclinical precursor to BICX104. Those efforts will now transition to support BICX104 as it advances toward first-in-human clinical trials. All activities covered under this new agreement will be conducted at Recro’s San Diego facility.

BioCorRx has received clearance from the FDA to proceed to human trials for BICX104, which is a biodegradable, long-acting subcutaneous pellet of naltrexone for the treatment of opioid use disorder. The treatment is being developed under BioCorRx Pharmaceuticals, BioCorRx’s controlled R&D subsidiary.

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