Research Project
9697952
BioCorRx is developing BICX102, a subcutaneous solid depot pellet of the opioid antagonist naltrexone (NTX). NTX is a proven treatment for opioid use disorder (OUD). A single BICX102 implantation will provide continual blockade of opioid receptors for up to 3 months. This can prevent patients from being affected adversely by almost any opioid relapse event, while improving efficacy and adherence to behavioral programs that support long term management and recovery. The BICX102 pellet can be removed if adverse drug reactions occur. BICX102 is being developed via the 505(b)2 FDA pathway as NTX and the other ingredients have been approved individually by the FDA; and BICX102 has been in clinical use in Russia as Prodetoxone® for >12 years. This UG3-UH3 proposal comprises the steps to achieve FDA approval. 2 million+ Americans have OUDs, with ~42,000 opioid overdose deaths (2016). The opioid epidemic cost $504 billion in 2015. ~91% of those in recovery experience relapse, and 80% do so within one month. Long-term abstinence is difficult to achieve due to poor compliance to effective therapies like NTX tablets and monthly injections. Our innovative solution is BICX102: a safe and effective 3-month subcutaneous depot pellet/implant containing NTX (1000 mg) that is less reliant on patient compliance. FDA guidance has indicated that they may rely on our proposed studies and existing data on BICX102 and its ingredients for the basis for 505(b)2 approval. BioCorRx has a team of experts in opioid treatment, regulation, CMC, nonclinical, clinical development and regulatory affairs to complete this project using outstanding facilities that are routinely used in the studies proposed. Aim 1: Chemistry Manufacturing and Controls (CMC): BICX102; Comprehensive Plan for Formulation Development, Technology Transfer, Clinical Batch Manufacture, FDA Registration Batch Manufacture and Stability Testing. Deliverable 1: Establish GMP facility to manufacture drug product (3-month Naltrexone/TCA Implant) for research and development and commercialization. Aim 2: Pivotal GLP Safety, Pharmacokinetic Study of BICX102, Revia, and Kenalog. Deliverable 2: Submission of IND application to the FDA for review. UG3 Transition Milestone: Successful approval of the IND by the FDA to proceed to the clinical stage. Aim 3: Comparative Single and Multiple Dose Pharmacokinetics of 3-month BICX102 Naltrexone Depot. Deliverable 3: Sustained release naltrexone serum levels above 1-2 ng/ml for up to 3 months. UH3 Milestone: Submission of 505(b)2 NDA application to FDA for marketing approval. Conclusion: Getting BICX102 to the market quickly is a national priority which necessitates effective and timely interactions between BioCorRx and the FDA. This milestone driven grant proposal is outstanding because it is following a 505(b)2 regulatory path that has been deemed acceptable by the FDA to achieve approval. We know from extensive non-clinical and clinical studies that BICX102 will be effective. This grant will result in the approval of BICX102 in Year 4 post award.
