BioCorRx Retains Innovative Science Solutions to Guide FDA Regulatory Process for its Naltrexone Products
ANAHEIM, CA -- (Marketwired) -- 01/12/17 -- BioCorRx Inc. (OTC PINK: BICX) (the "Company"), a developer and provider of advanced solutions in the treatment of alcohol and opioid addictions, today announced it has retained Innovative Science Solutions, LLC, ("ISS") a leading scientific consulting firm, headquartered in Morristown, New Jersey to help guide the Company's regulatory strategy for the submission of its sustained release naltrexone product(s) to the U.S. Food and Drug Administration (FDA). The company's injectable naltrexone product, BICX101 is being developed under its BioCorRx Pharmaceuticals subsidiary in partnership with TheraKine, Ltd and is currently in preclinical development. The company also owns two, already developed, naltrexone pellet products which are implanted subcutaneously.
Naltrexone is a non-addictive opioid antagonist for the treatment of alcohol and opioid dependence. It can reduce or eliminate cravings for alcohol and opioids, as well as block dangerous effects of opioid use such as overdose. Naltrexone was approved by the FDA in 1984, in tablet form, for opioid addiction and approved subsequently in 1994 for alcohol use disorders (AUD). It works by attaching to opioid receptors in the brain for the duration of the extended release (injectable and pellet forms), blocking the cravings and/or certain effects of opioids and alcohol.
BioCorRx is pleased to announce that Dr. Steven M. Weisman, a founder of ISS and Head of Clinical and Regulatory Support, will play a leading role in guiding the Company through its anticipated FDA 505(b)(2) regulatory submission(s). This 505(b)(2) submission route typically provides substantial cost and time to market benefits versus traditional New Drug Applications with the FDA. The Company's expected ability to utilize the abbreviated 505(b)(2) approval process is potentially due to the fact naltrexone has been approved by the FDA in other delivery forms several times since 1985.
Dr. Weisman has over 20 years of experience in pharmacology, toxicology, pharmaceutical product development, clinical and regulatory affairs, and marketing evaluation. As head of ISS' Clinical and Regulatory Support practice, he manages all aspects of the FDA advisory committee process for many of the largest pharmaceutical companies and represents companies before regulatory authorities around the world. He played a leading role to the removal of PPA (phenylpropanolamine) and analgesic Aleve, from a prescription-only product to over-the-counter form. Prior to founding ISS he ran the pharmaceutical and food practices at a major scientific consulting firm in Washington, DC. Before that, he served as Global Director of Medical and Clinical Affairs at Bayer, Director of Strategic Research at Sterling Winthrop, and held similar positions at Hoffman La Roche and Procter & Gamble. Dr. Weisman received his PhD in Pharmacology from Cornell University Medical College and completed his postdoctoral training in Immunopharmacology at the Roche Institute of Molecular Biology.
As previously announced, Covance, Inc., was recently selected as the Company's Contract Research Organization (CRO) for non-clinical studies to determine the lead-formulation that would be used in planned future clinical studies for BICX101. If successful, BioCorRx's lead-formulation is expected to release therapeutic levels of naltrexone for approximately 30 days. The company's pellet formulas have already been developed and proven effective by various third parties.
Brady Granier, President, CEO and Director stated, "We are excited to move forward with our formulas and very pleased to have selected ISS to oversee and help expedite our planned submission to the FDA. ISS is a top scientific consulting firm consisting of a team of skilled scientific and regulatory consultants with broad experience and a proven track record in preparing regulatory submissions for worldwide pharmaceutical, biotechnology, and medical device companies. We look forward to the prospect of completing the preclinical studies early this year and presentation of the data to the FDA in the pre-IND meeting. We are also very confident with the effectiveness of our naltrexone pellet products as we have seen first-hand how effective they are in humans over the last several years. Dr. Weisman's insight and knowledge of the regulatory process will be an invaluable asset to maximize the potential for successful commercialization while minimizing approval time."
Steven M. Weisman, Ph.D., Head of Clinical and Regulatory Support of Innovative Science Solutions Inc. commented, "I look forward to working closely with BioCorRx and utilizing my expertise to advance its naltrexone products through the regulatory process, which has the potential to become the standard of care to fight the opioid epidemic and global alcoholism problem. These products are expected to provide more efficient delivery of naltrexone with the better patient adherence to monthly injections or implanted pellets that can last several months."
BioCorRx Inc. (OTC PINK: 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.
Source: BioCorRx, Inc.
Released January 12, 2017