BIOCORRX INC - BICX OTCQB
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BioCorRx Submits Pre-IND Package to FDA for its Naltrexone Implant, BICX102
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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.” About BioCorRx® 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. BioCorRx Announces Nine Centers to Implement BioCorRx Recovery Program Across Maryland and Virginia
ANAHEIM, CA--(Marketwired
- Oct 25, 2017) -
BioCorRx Inc. ( Dr. Thomas Raley, Founder of ASAP, commented, "Maryland and Virginia are grossly underserved addiction treatment markets where opioid use disorder continues to rise at an alarming rate. ASAP is happy to offer patients BioCorRx's innovative drug recovery program, a comprehensive, naltrexone-focused medication-assisted treatment (MAT) program for alcohol, heroin, and other opioid addictions. We believe this cutting-edge and highly effective treatment modality has the potential to save many lives from this current epidemic. We plan to offer this program to those individuals who desire to wean off opioids, buprenorphine, alcohol, and heroin." Brady Granier, CEO, President, and Director of BioCorRx, stated, "We are very pleased that ASAP has chosen to implement the BioCorRx Recovery Program in all nine of its centers. This new partnership increases access points to our program in this affected region. We look forward to working with Dr. Raley and his team. As more centers and groups continue to sign up, we believe we can make a meaningful impact in the lives of people suffering from alcohol and opioid use disorders."
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About BioCorRx BioCorRx CEO Brady Granier Appears on MichaeLA on HLN to Discuss Alcohol Addiction
ANAHEIM, CA--(Marketwired -
Oct 17, 2017) - BioCorRx
Inc. ( Brady Granier, President & CEO of BioCorRx, stated, "According to an alarming study published in the September 2017 issue of JAMA Psychiatry, one in eight American adults now meet the diagnostic criteria for alcoholism. Further, nearly one in four adults under age 30 meets the diagnostic criteria for alcoholism. Alcohol use disorder (AUD) rose by 49 percent in the first decade of the 2000s, and now affects 12.7 percent of the American population. Our program, the BioCorRx Recovery Program, combines a compounded naltrexone implant per patient prescription with structured, proprietary cognitive behavioral therapy (CBT) modules, as well as peer support. Our company was originally founded primarily for the treatment of alcohol use disorder which is a larger problem, when compared to other substance use disorders, yet doesn't get the attention it deserves. We have seen some very amazing transformations over the years from those participating in our program for AUD. We encourage those families and individuals suffering to give our program a closer look." About BioCorRx
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