BioCorRx Granted Pre-IND Meeting with FDA for BICX101
ANAHEIM, CA / ACCESSWIRE / May 25, 2017 / BioCorRx Inc. (OTCQB: BICX) (the "Company"), a developer and provider of advanced solutions in the treatment of alcohol and opioid addictions, today announced that the U.S. Food & Drug Administration (FDA) has granted a pre-IND meeting to the Company and it is scheduled to take place on Tuesday, September 19, 2017 in order 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 acceptance 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.
Brady Granier, President, CEO and Director, stated, "We are appreciative of the FDA's response and look forward to meeting with them to present our plan for BICX101. Between now and the meeting date, we will continue to conduct more preclinical studies on BICX101 at Covance in order to collect additional data which will go into our briefing document to the FDA and IND filing. We continue to be excited about the potential for BICX101 to be utilized for multiple substance use disorder indications in the future."
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 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 proprietary counseling program (plus peer support 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 May 25, 2017