BioCorRx Awarded NIDA Grant of Approximately $5.7 Million for BICX102, a Sustained Release Naltrexone Implant for the Treatment of Opioid Use Disorder
ANAHEIM, CA, Jan. 22, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of advanced solutions in the treatment of substance use disorders, announced today that it has been awarded a 2-year grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under award number UG3DA047925 for the development of BICX102, the Company’s single administration, multi-month sustained release naltrexone implant for the treatment of opioid use disorder. The Company is seeking FDA approval for BICX102.
This award is the result of the Company’s application under RFA DA-19-002, “Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)”. There are two phases to this grant opportunity; UG3 and UH3. This award announcement pertains to UG3 of which $2,842,430 is awarded for the period of February 1, 2019 through January 31, 2020 (Year 1), followed by the Year 2 amount of $2,831,838 based on satisfactory progress of the project and availability of funds. The total amount for the UG3 phase is $5,674,268. In the original application, the Company also requested over $3.6 million for the UH3 phase. The UH3 award is anticipated at a later date upon completion of milestones stated in the application which would enable transition from UG3 to UH3 phase, and based on availability of funds.
NIDA special emphasis expert reviewers commented that we provided an excellent proposal from “an outstanding industry team” with a “strong rationale for the technology based on previous basic research and clinical experience” and recognized “extensive experience with the parent drug and delivery technology (clinical) suggest that the development plan has a high likelihood of progressing to an approved treatment in the US.”
Brady Granier, BioCorRx CEO, stated, “We are honored to have received this non-dilutive grant from NIDA/NIH, which we believe provides us with the funding to help achieve FDA approval of BICX102. Our thanks go out to the staff at NIH/NIDA and the reviewers who believed in the project. We believe this grant validates the clinical potential of BICX102 for the treatment of opioid use disorder. Current treatment options are limited for people with opioid use disorder (OUD) and BICX102 will be a new tool in this battle which affects over 2 million Americans. We also feel that BICX102 may be effective in helping the one in eight American adults or 12.7% of the U.S. population who now meet the diagnostic criteria for alcohol use disorder. We look forward to rapidly advancing BICX102 through the regulatory pathway.”
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, and can prevent opioid overdose following relapse. The second component of the program developed by BioCorRx Inc. is a Cognitive Behavioral Therapy (CBT) program tailored specifically for the treatment of alcoholism and other substance abuse addictions for those receiving long-term naltrexone treatment. The Company also conducts R&D under its controlled subsidiary, BioCorRx Pharmaceuticals. For more information on BICX and product pipeline, 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 January 22, 2019