BioCorRx Announces First Subject Dosed in Phase 1 Clinical Trial of Implantable Naltrexone Pellet
BioCorRx Inc. recently announced the first subject has been dosed in the Phase 1 clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD), which is being developed under BioCorRx Pharmaceuticals, Inc., the company’s controlled clinical-stage pharmaceutical company.
“The initiation of our first-in-human clinical trial is a major milestone for our company and the culmination of significant efforts across our preclinical, clinical, regulatory, and manufacturing partners,” said Brady Granier, President, Director of BioCorRx Inc. and CEO of BioCorRx Pharmaceuticals Inc. “More than 107,000 Americans died of drug overdoses in 2021, which roughly translates to one US overdose death every 5 minutes. Not only is this tragic and staggering, but gaps in opioid use disorder treatment continue to widen. Our goal is to quickly bring BICX104 to market and provide an additional treatment option for those suffering from substance use disorders. With the first subject being dosed, we are now focused on enrolling and scheduling the remaining subjects.”
The BICX104 clinical study is a Phase 1, open-label, single-center study in two parallel groups of randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and the marketed once-a-month intramuscular depot naltrexone injection. The study is led by Dr. Joel M. Neutel MD, Director of Research at the Orange County Research Center (OCRC), located in Tustin, CA. Interested participants can reach out directly to OCRC on their website at www.ocresearchcenter.com. Information about the study can also be found at www.clinicaltrials.gov under NCT number 04828694.
BICX104 is being developed in collaboration with the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under RFA DA-19-002, Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional). The company has an active Investigational New Drug (IND) status, and the FDA has deemed the 505(b)(2) abbreviated pathway acceptable, as well the opportunity to seek eventual dual indication on the product for OUD and Alcohol Use Disorder (AUD).
BioCorRx Inc. 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; 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, visit www.BioCorRx.com.
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