BioCorRx Completes Pre-IND Meeting with FDA; Reports Company to Move Forward with BICX102
ANAHEIM, CA , Jan. 26, 2018 (GLOBE NEWSWIRE) -- BioCorRx Inc. (OTCQB: BICX) (the "Company"), a developer and provider of advanced solutions in the treatment of alcohol and opioid addictions, today announced that it held a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) on January 24, 2018 regarding the Company's naltrexone implant, BICX102. BICX102 is the Company's sustained release naltrexone implant for the treatment of opioid and alcohol use disorders.
The National Institute on Drug Abuse (NIDA) joined the meeting as observers, along with Brady Granier, CEO and Director of BioCorRx, and the Company’s regulatory experts and consultants. In the meeting, BioCorRx discussed the responses that were received prior to the meeting from the FDA in regard to the pre-IND package, which had been submitted last month. The package included information on BICX102, as well as the proposed development plan for commercialization. As a result of the meeting, the Company plans to move forward with the product as anticipated.
Brady Granier, President, CEO and Director of BioCorRx, stated, “We are pleased with the FDA’s responses to our development plan and appreciative of their time in the meeting. We look forward to providing a more thorough update as soon as we receive and review the meeting minutes from the FDA as to confirm all items verbally discussed. In the meantime, we will continue moving forward with our BICX102 plans.”
BioCorRx Inc. (OTCQB: BICX) is an addiction treatment company offering a unique approach to the treatment of substance abuse addiction. The BioCorRx® Recovery Program, a non-addictive, medication-assisted treatment (MAT) program, consists of two main components. The first component of the program consists of the use of sustained release naltrexone, usually in implantable form and under the direction and care of an independent licensed physician. Implant forms of naltrexone deliver the non-addictive medicine which is an opioid antagonist that can significantly reduce physical cravings for alcohol and opioids, as well as some of their effects. The second component of the program developed by BioCorRx Inc. is a proprietary cognitive behavioral therapy (CBT) program specifically tailored for the treatment of alcohol and opioid use disorders for those receiving sustain release naltrexone treatment. The behavioral portion of the program also includes overlapping peer recovery support and tracking. The Company also has an R&D subsidiary, BioCorRx Pharmaceuticals, which is currently developing injectable and implantable naltrexone products for potential future regulatory approval. For more information on BICX, 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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Released January 26, 2018