BioCorRx Submits Pre-IND Package to FDA for its Naltrexone Implant, BICX102
ANAHEIM, CA, Dec. 19, 2017 (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 has submitted its pre-Investigational New Drug (pre-IND) package to the U.S. Food and Drug Administration (FDA) for 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 submitted pre-IND package provides the FDA with current information on BICX102, as well as the proposed development plan. The purpose of the meeting is to review the development plan and to seek the agency’s guidance on further development and commercialization of BICX102.
This pre-IND submission follows BioCorRx's recent announcement that the FDA has granted the Company a Type-B pre-IND meeting scheduled for January 24, 2018. As previously announced, the National Institute on Drug Abuse (NIDA) has agreed to attend the pre-IND meeting for BICX102 with the FDA. NIDA and National Institute on Alcohol Abuse and Alcoholism (NIAAA) have also received the documents which were submitted to the FDA.
Brady Granier, CEO, President, and Director of BioCorRx, commented, “We are pleased that BioCorRx® will be starting out the New Year with a meeting with the FDA. The submission of the pre-IND package is a major step that BioCorRx® has completed in its efforts to bring BICX102 to market. We thank all of our advisors and consultants for their tireless efforts in putting together a package that we feel will lead to a very productive meeting. We are pursuing the 505(b)(2) regulatory pathway, which we believe will be a more rapid and cost-effective route to approval. We are pleased that both NIDA and NIAAA are involved in this process and we look forward to the meeting with the FDA.”
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 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 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 December 19, 2017