BioCorRx Submits Meeting Request for Pre-IND Meeting with FDA for BICX101
ANAHEIM, CA / ACCESSWIRE / April 10, 2017 / BioCorRx Inc. (BICX) (the "Company"), a developer and provider of advanced solutions in the treatment of alcohol and opioid addictions, today announced that Innovative Science Solutions, LLC (ISS), on behalf of BioCorRx, Inc., has formally requested a pre-IND meeting with the U.S. Food & Drug Administration (FDA) to review the development plan to market BICX101, an injectable, sustained release naltrexone, for the treatment of opioid addiction and alcohol use disorders.
At the pre-IND meeting, BioCorRx plans to seek guidance from the FDA on its proposal to file a New Drug Application (NDA) under Section 505(b)(2) for approval of BICX101, based on the FDA's previous determination of the safety and effectiveness of naltrexone for the treatment of opioid addiction and alcohol use disorders. Pre-IND meetings are typically scheduled within 60 days of a meeting request, but that is up to the FDA and not guaranteed.
Brady Granier, CEO, President, and Director, stated, "The pre-IND meeting request marks an important next step in BioCorRx's development and approval plan for BICX101. Last week, we announced that multiple formulations under preclinical development were successful in achieving sustained release of naltrexone for 28 days in vivo. Since then, we discovered that one of them had measurable levels at 35 days. We will continue to fine tune these formulas with the goal of achieving maximum efficiency and results while we await the FDA meeting. We are very excited about the potential for BICX101 to be utilized for multiple substance use disorder indications in the future."
BioCorRx Inc. (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 an outpatient implant procedure performed by a licensed physician. The implant delivers the non-addictive medicine, naltrexone, an opioid antagonist that can significantly reduce physical cravings for alcohol and opioids. The second component of the program developed by BioCorRx Inc. is a one-on-one counseling program specifically tailored for the treatment of alcoholism and other substance abuse addictions for those receiving long-term naltrexone treatment. The Company also has an R&D subsidiary, BioCorRx Pharmaceuticals, which is currently developing a new injectable naltrexone technology (BICX101) through a partnership with TheraKine Ltd. The company plans to seek FDA approval for BICX101 and/or its naltrexone implant product(s). 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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SOURCE: BioCorRx Inc.
Released April 10, 2017