BioCorRx Submits Pre-IND Package to FDA for its Naltrexone Implant, BICX102
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DECEMBER 19, 2017
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
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