Pharma Focus America

BioCorRx Requests FDA Fast Track Designation for BICX104: An Implantable Biodegradable Naltrexone Pellet to Treat Opioid Use Disorder

Wednesday, July 19, 2023

BioCorRx Inc. (OTCQB: BICX), a company specializing in innovative treatment programs for substance abuse and related disorders, has announced the submission of a fast track application to the U.S. Food and Drug Administration (FDA) for BICX104. This application pertains to an implantable biodegradable naltrexone pellet designed to treat opioid use disorder (OUD).

The fast track designation, if granted, would expedite the development and review process for BICX104, considering it’s potential to address serious or life-threatening conditions and meet unmet medical needs. The primary goal is to bring this important treatment to patients more quickly. The FDA's fast track program allows for more frequent interactions between the drug developer and the FDA to discuss the development plan and ensure the collection of appropriate data to support drug approval. It may lead to accelerated approval and priority review if specific criteria are met.

Brady Granier, President of BioCorRx, Inc., Director of BioCorRx, Inc., and CEO of BioCorRx Pharmaceuticals, Inc., stated that they reported positive interim safety and pharmacokinetic (PK) results from the Phase I clinical trial of BICX104 at the 4th Annual NIH HEAL Initiative Investigator Meeting in March 2023. The data indicated that BICX104 was generally well-tolerated, without any serious adverse events, and provided therapeutic levels of naltrexone for an average of 84 days. Based on these promising results, the company has submitted the fast track application and is also preparing to apply for expanded access. Granier emphasized the urgency of addressing the opioid overdose epidemic, which caused an estimated 80,816 deaths in 2021, as it is a significant public health crisis that requires prompt action.

BICX104, developed by BioCorRx Pharmaceuticals, Inc., is an implantable subcutaneous pellet containing naltrexone intended to enhance patient compliance with the treatment of OUD compared to other existing treatments. The clinical study for BICX104 involves a Phase I, open-label, single-center trial with randomized healthy volunteers to evaluate the pharmacokinetics and safety of the implantable subcutaneous naltrexone pellets in comparison with Vivitrol, a once-a-month intramuscular depot naltrexone injection. 

The development of BICX104 is being facilitated through a cooperative agreement with the National Institute on Drug Abuse (NIDA), a part of the National Institutes of Health (NIH). This agreement, funded by the Helping to End Addiction Long-term Initiative (NIH HEAL Initiative), focuses on speeding up scientific solutions to address the national opioid public health crisis. The initiative concentrates on improving prevention and treatment strategies for opioid misuse and addiction while enhancing pain management.

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