BioCorRx Submits Fast Track Application to FDA for BICX104, an Implantable Biodegradable Naltrexone Pellet for The Treatment of Opioid Use Disorder
- BioCorRx has submitted a fast track application to the FDA for BICX104, demonstrating the company's commitment to addressing the opioid overdose epidemic.
- Interim positive safety and pharmacokinetic results for the Phase I clinical trial of BICX104 have shown that the treatment was generally well-tolerated and provided therapeutic levels of naltrexone for a mean of 84 days.
- The fast track designation aims to expedite the development and review of new drugs intended to treat serious or life-threatening conditions, with the potential to fill unmet medical needs.
- The opioid overdose epidemic, causing an estimated 80,816 overdose deaths in 2021, is a significant public health crisis, and BioCorRx aims to make BICX104 available to patients and prescribers as soon as possible.
- The FDA typically responds to fast track designation requests within 60 days or less.
- None.
ANAHEIM, CA, July 18, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and related disorders, today announced the submission of a fast track application to the U.S. Food and Drug Administration (“FDA”) for BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD).
Fast track designation aims to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to fill unmet medical needs. The purpose is to get important new drugs to patients faster. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. Drugs that are granted this designation are given the opportunity for more frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval. It can lead to accelerated approval and priority review, if relevant criteria are met.
Brady Granier, President of BioCorRx, Inc., Director of BioCorRx, Inc., and CEO of BioCorRx Pharmaceuticals, Inc., commented, “In March 2023, we reported interim positive safety and pharmacokinetic (PK) results for the Phase I clinical trial of, at the 4th Annual NIH HEAL Initiative Investigator Meeting. Data showed that BICX104 was generally well-tolerated, with no serious adverse events, and provided subjects with therapeutic levels of naltrexone for a mean of 84 days. Based on these results, we have submitted for fast track designation and we are preparing to also apply for expanded access. The opioid overdose epidemic, causing an estimated 80,816 overdose deaths in 2021, almost doubling from roughly 42,000 in 2016, is such a significant and deepening public health crisis that BioCorRx believes it is urgent to help patients and prescribers as soon as possible by making BICX104 available to them. Typically, the FDA responds to fast track designation requests within 60 days or less. We look forward to providing additional updates.”
BICX104, which is being developed under BioCorRx Pharmaceuticals, Inc., the Company’s controlled clinical stage pharmaceutical company, is a biodegradable, long-acting subcutaneous pellet of naltrexone for the treatment of OUD being developed with the goal of improving patient compliance to naltrexone therapy compared to other marketed treatments. The BICX104 clinical study is a Phase I, open-label, single-center study in two parallel groups of randomized healthy volunteers to evaluate the PK and safety of BICX104 implantable subcutaneous naltrexone pellets and the marketed once-a-month intramuscular depot naltrexone injection, Vivitrol. Information about the study can also be found at www.clinicaltrials.gov under NCT number 04828694.
BICX104 is being developed through a cooperative agreement with the NIDA, part of the NIH, under award number UH3DA047925, funded by the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative. This award is subject to the Cooperative Agreement Terms and Conditions of Award as set forth in RFA DA-19-002 entitled, Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional).
The NIH Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, is an aggressive, trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. For more information, visit: https://heal.nih.gov.
About BioCorRx
BioCorRx Inc. (OTCQB: BICX) is an addiction treatment solutions company offering a unique approach to the treatment of substance use and other related disorders. Beat Addiction Recovery is a substance use disorder recovery program that typically includes BioCorRx's proprietary Cognitive Behavioral Therapy (CBT) modules along with peer support via mobile app along with medication prescribed by an independent treating physician under their discretion. The UnCraveRx® Weight Loss Program is also a medication assisted weight loss program that includes access to concierge on-demand wellness specialists: nutritionists, fitness experts and personal support from behavioral experts; please visit www.uncraverx.com for more information on UnCraveRx®. The Company also controls BioCorRx Pharmaceuticals, a clinical stage drug development subsidiary currently seeking FDA approval for BICX104, an implantable naltrexone pellet for treatment of alcohol and opioid use disorders. For more information on BICX and its subsidiary pipeline, please visit www.BioCorRx.com.
Safe Harbor Statement
The information in this release includes forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "estimate," "become," "plan," "will," and similar expressions. These forward-looking statements involve known and unknown. risks as well as uncertainties. Although the Company believes that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof.
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