UH3DA047925

Development of a 3-month implantable depot pellet of naltrexone for the treatment of opioid use disorder. - 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.

Biocorrx

TO SUPPORT BASIC AND CLINICAL NEUROSCIENCE, BIOMEDICAL, BEHAVIORAL AND SOCIAL SCIENCE, EPIDEMIOLOGIC, HEALTH SERVICES AND HEALTH DISPARITY RESEARCH. TO DEVELOP NEW KNOWLEDGE AND APPROACHES RELATED TO THE PREVENTION, DIAGNOSIS, TREATMENT, ETIOLOGY, AND CONSEQUENCES OF DRUG ABUSE AND ADDICTION, INCLUDING HIV/AIDS. TO SUPPORT RESEARCH TRAINING AND RESEARCH SCIENTIST DEVELOPMENT. TO SUPPORT DISSEMINATION OF RESEARCH FINDINGS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) LEGISLATION IS INTENDED TO EXPAND AND IMPROVE THE SBIR PROGRAMS TO EMPHASIZE AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF TECHNOLOGY DEVELOPED THROUGH FEDERAL SBIR RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN THE SBIR PROGRAM. THE LEGISLATION INTENDS THAT THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.279 - Drug Abuse and Addiction Research Programs

National Institute on Drug Abuse (NIDA) [HHS - NIH]

California United States

State-Wide

Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trials Optional) (RFA-DA-19-002)

Amendment Since initial award the End Date has been extended from 08/31/23 to 08/31/24 and the total obligations have increased 3% from $3,453,367 to $3,552,798.