ANAHEIM, CA, April 13, 2021 (GLOBE NEWSWIRE) — through NewMediaWire — BioCorRx Inc. (OTCQB: BICX) (“BioCorRx” or the “Firm”), a developer and supplier of superior options within the therapy of substance use problems, introduced at the moment that the Firm has filed an Investigational New Drug (IND) utility with the U.S. Meals and Drug Administration (FDA) for initiation of a medical trial of BICX104, a naltrexone pellet implant for the therapy of Opioid Use Dysfunction (OUD). Throughout prior nonclinical research, a number of variations of BICX102 had been evaluated and the present variation, BICX104, was chosen for development to the IND stage.
BICX104 is a biodegradable, long-acting subcutaneous pellet of naltrexone being developed in partnership with the Nationwide Institutes of Well being (NIH) and the Nationwide Institute on Drug Abuse below RFA DA-19-002, “Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional).” The Firm had a earlier pre-IND assembly with the FDA, at which period the FDA deemed the 505(b)(2) pathway acceptable. The Part 505(b)(2) regulatory pathway below the Federal Meals, Drug and Beauty Act (the “FFDCA”) gives a probably shortened regulatory approval window. The FDA additionally said that the Firm might search eventual twin indication on the product for OUD and Alcohol Use Dysfunction (AUD).
Bal Brar DVM, PhD, BioCorRx SVP of Drug Improvement and principal investigator for the NIDA funded analysis, said, “We’re very happy to announce this regulatory submission of BICX104, a gradual launch implantable pellet for opioid use dysfunction. This medicine has the potential to avoid wasting quite a few lives bothered by the opioid epidemic devastating the nation.”
Brady Granier, President, and Director of BioCorRx, Inc., and CEO of BioCorRx Prescribed drugs, Inc., said, “I need to thank all of our companions for serving to us attain this milestone for our firm. What we had been in a position to obtain throughout a 12 months of uncertainty with the coronavirus pandemic has been outstanding. We sit up for advancing BICX104 to the medical part upon IND clearance in order that we are able to transfer nearer to bringing this vital medicine to the lots. The opioid epidemic has sadly gotten worse since COVID-19 and we hope that BICX104 can quickly be obtainable to assist these in want.”
In line with data provided by the Facilities for Illness Management and Prevention (CDC), over 81,000 drug overdose deaths occurred within the U.S. between June 2019 and Might 2020. This information represents probably the most overdose deaths ever recorded in a 12-month interval and consultants attribute this enhance, at the least partly, to the COVID-19 pandemic.
“We’ve been working tirelessly to advance our naltrexone pellet for a number of years now and with the assistance of NIDA, our companions and our shareholders, it’s very thrilling to have the ability to take this subsequent step towards potential FDA approval,” BioCorRx CEO, CFO and Director Lourdes Felix stated. “The pandemic has exasperated the opioid epidemic and the urgency to discover a means to assist deal with people who find themselves affected by substance use problems is extra essential than ever.”
Analysis reported on this publication was supported by NIDA of the NIH below Award Quantity UG3DA047925. The content material is solely the accountability of the authors and doesn’t essentially symbolize the official views of the NIH.
BioCorRx Inc. (OTCQB: BICX) is an habit therapy options firm providing a novel method to the therapy of substance use and different associated problems. Beat Habit Restoration is a substance use dysfunction restoration program that sometimes consists of BioCorRx’s proprietary Cognitive Behavioral Remedy (CBT) modules together with peer help through cell app together with medicine prescribed by an unbiased treating doctor below their discretion. The UnCraveRx™ Weight Loss Program can also be a drugs assisted weight reduction program; please go to www.uncraverx.com for extra info on UnCraveRx™. The Firm additionally conducts R&D below its managed subsidiary, BioCorRx Prescribed drugs. For extra info on BICX and product pipeline, please go to www.BioCorRx.com.
Secure Harbor Assertion
The knowledge on this launch consists of forward-looking statements. These forward-looking statements usually are recognized by the phrases “consider,” “mission,” “estimate,” “turn into,” “plan,” “will,” and related expressions. These forward-looking statements contain recognized and unknown dangers in addition to uncertainties. Though the Firm believes that its expectations are primarily based on affordable assumptions, the precise outcomes that the Firm might obtain might differ materially from any forward-looking statements, which mirror the opinions of the administration of the Firm solely as of the date hereof.
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