BioCorRx Pharmaceuticals Inc. Awarded NIDA Grant of Approximately $11 million Over Three Years for Research on BICX104, a Naltrexone Implant in Combination with Bupropion for the Treatment of MUD

ANAHEIM, CA , Feb. 28, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire –  BioCorRx Inc . (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance use and related disorders, announced that its subsidiary BioCorRx Pharmaceuticals Inc. has been awarded a 3-year grant for approximately $11 million from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under award number U01DA059994 for the development of BICX104, a subcutaneous, long-duration naltrexone implantable pellet, alone or in conjunction with bupropion for the treatment of methamphetamine use disorder (MUD).

Clinical studies have supported the use of naltrexone in the treatment of MUD, as well as the combination of naltrexone with bupropion to significantly reduce the use of methamphetamines.

The number of people meeting the criteria for MUD, and methamphetamine-involved overdose deaths and arrests, increased from 2015 to 2019 according to a secondary data analysis by Pew, which shows that arrests for meth possession during this period increased by 59%. Data reported by NSDUH and CDC showed a 20% increase in MUD from 2015 to 2019 (from 872K to 1.048M), with overdose deaths increasing by 182% from 2015 to 2019.

MUD represents a significant public health concern, with devastating consequences for individuals, families, and communities across the country. Despite the growing prevalence of MUD, effective treatment options remain limited, underscoring the urgent need for innovative approaches to address this complex and challenging condition.

Lourdes Felix, CEO, CFO, and Director of BioCorRx Inc ., and President, and Chairman of BioCorRx Pharmaceuticals Inc., commented, “We are honored to receive this non-dilutive grant from NIDA, which underscores our commitment to advancing the field of addiction treatment and improving outcomes for individuals affected by MUD. Currently, there are no approved medications for MUD, and populations at risk of methamphetamine-involved overdose deaths are diversifying. This funding will accelerate our research efforts to develop BICX104 alone or in conjunction with bupropion for the treatment of MUD; potentially helping more individuals achieve reduced drug use and lasting recovery and reclaim their lives.”

About BICX104
BICX104 is a biodegradable, long-acting subcutaneous pellet of naltrexone for the treatment of opioid use disorder (OUD) being developed with the goal of improving patient compliance to naltrexone therapy compared to other marketed treatments. In Phase I, an open-label, single-center study in two parallel groups of randomized healthy volunteers to evaluate the PK and safety of BICX104 and the once-a-month intramuscular naltrexone injection (Vivitrol), BICX104 was well tolerated with no serious adverse events and achieved 84 days of therapeutic naltrexone plasma concentrations. BICX104 is being developed under BioCorRx Pharmaceuticals Inc., the Company’s majority-owned clinical-stage pharmaceutical subsidiary.

Information about the study can also be found at www.clinicaltrials.gov under NCT number 04828694.

BICX104 is being developed through a cooperative agreement with the NIDA, part of the NIH, under award number UH3DA047925, funded by the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative. This award is subject to the Cooperative Agreement Terms and Conditions of Award as set forth in RFA DA-19-002 entitled, Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional).

The NIH Helping to End Addiction Long-term® Initiative or NIH HEAL Initiative®, is an aggressive, trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction and enhancing pain management. For more information, visit: https://heal.nih.gov.

Research reported in this publication was supported by the National Institute On Drug Abuse of the National Institutes of Health under Award Number U01DA059994 and UH3DA047925. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About MUD
Research has shown that methamphetamine is a highly addictive stimulant and one of the most misused stimulant drugs in the world. Some of the side effects of MUD are severe dental problems, memory loss, aggression, psychotic behavior, and damage to the cardiovascular system. In 2022 the National Survey on Drug Use and Health reported that more than 16.6 million people used methamphetamine at least once during their lifetime.

About OUD
OUD is a chronic disorder, with serious potential consequences including disability, relapses, and death. Opioids, used medically for pain relief, have analgesic and central nervous system depressant effects as well as the potential to cause euphoria with an overpowering desire to use opioids despite the consequences. OUD can involve misuse of prescribed opioid medications, use of diverted opioid medications, or illicitly obtained heroin. OUD is typically a chronic and relapsing illness, that is associated with significantly increased rates of morbidity and mortality.

About BioCorRx Inc .
BioCorRx Inc . (OTCQB: BICX) is an addiction treatment solutions company offering a unique approach to the treatment of substance use and other related disorders. Beat Addiction Recovery is a substance use disorder recovery program that typically includes BioCorRx's proprietary Cognitive Behavioral Therapy (CBT) modules along with peer support via mobile app along with medication prescribed by an independent treating physician under their discretion. The UnCraveRx® Weight Loss Program is also a medication-assisted weight loss program that includes access to concierge on-demand wellness specialists: nutritionists, fitness experts, and personal support from behavioral experts, please visit www.uncraverx.com for more information on UnCraveRx®. The Company also controls BioCorRx Pharmaceuticals, a clinical-stage drug development subsidiary currently seeking FDA approval for BICX104, an implantable naltrexone pellet for the treatment of alcohol and opioid use disorders. For more information on BICX and its subsidiary pipeline, please visit www.BioCorRx.com.

Forward-Looking Statements
This press release contains 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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