BioCorRx Announces Update on NIDA Grant and Development of Naltrexone Implant for the Treatment of Opioid and Alcohol Use Disorders
ANAHEIM, CA, Jan. 15, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of advanced solutions in the treatment of substance use disorders, today announced that it has received a revised notice of award (NoA) to extend the current UG3 phase of the grant awarded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under award number UG3DA047925. The grant was awarded to support the advancement of a sustained release naltrexone implant for the treatment of opioid and alcohol use disorders being developed by BioCorRx’s subsidiary, BioCorRx Pharmaceuticals Inc.
The grant that was awarded in January 2019, is the result of the Company’s application under RFA DA-19-002, “Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional).” The UG3 phase covers non-clinical development and studies. The UH3 phase (clinical trials) is anticipated this year upon completion of milestones stated in the application, which would enable transition from the UG3 to UH3 phase and based on availability of funds.
Brady Granier, President, and Director of BioCorRx, Inc., and CEO of BioCorRx Pharmaceuticals, Inc., stated, “We are thankful for our continued partnership with the NIH and NIDA. This notice of award revision allows us more time to get our IND application finalized and submitted to the U.S. Food and Drug Administration (FDA). As stated late last year, our team has been working on the IND application with various third parties to receive and review data, and to prepare the IND application for submission. We have had some delays which led to the need for the extension, but we are happy to report that most of the information needed for the application has been received and processed since the last update thanks to our partners who worked through the holiday season. As a result, we anticipate submitting the IND application to the FDA in February. However, we want to reiterate that we rely heavily on third parties to complete the application which could potentially lead to further delays. The current pandemic has overshadowed the opioid epidemic, which unfortunately seems to have worsened over the last year. We are looking forward to the day when this product could be added to the armamentarium to battle the opioid crisis.”
Lourdes Felix, CEO, CFO and Director of BioCorRx Inc., commented, “We are pleased to be awarded this extension and appreciate the support of NIH/NIDA, as we continue to progress our pivotal good laboratory practice (GLP) preclinical studies. The aim of the preclinical studies is to collect data in support of the safety of our product in order to submit our IND application to the FDA. We do not anticipate much more delays, if any, in terms of completing these pivotal studies and we continue to strive to submit our IND application soon with the goal of starting human studies this year.”
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; please visit www.uncraverx.com for more information on UnCraveRx™. The Company also conducts R&D under its controlled subsidiary, BioCorRx Pharmaceuticals. For more information on BICX and product pipeline, please visit www.BioCorRx.com.
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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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Released January 15, 2021