BioCorRx Submits Expanded Access Treatment Protocol to FDA for BICX104, Implantable Biodegradable Naltrexone Pellet for Treatment of Opioid Use Disorder
Company Hopes in 30 Days to Begin Making Its Drug Candidate Available to Help Patients and Address Public Health Crisis
ANAHEIM, CA, Aug. 15, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – BioCorRx Inc. (OTCQB: BICX) (the “Company”) today announced its submission to the US Food and Drug Administration (FDA) of an expanded access program application for BICX104 (implantable naltrexone pellet) for the treatment of opioid use disorder (OUD) patients that meet program eligibility criteria.
Brady Granier, President of BioCorRx, Inc., and CEO of BioCorRx Pharmaceuticals, Inc., stated, "We chose to submit this expanded access treatment protocol to bring the benefits of our safe, effective, and potentially life-saving naltrexone implant to patients suffering with OUD. Our Phase I clinical trial results encouraged us to apply to the FDA to get our BICX104 treatment to the public as soon as possible. If our expanded access application is approved, we look forward to implementing our program to promote the distribution of BICX104 to OUD patients through qualified health care providers. Per FDA guidance, we expect to know if we can proceed in doing so in 30 days. In the meantime, we continue to work on fulfilling the requirements needed for our New Drug Application (NDA) for full FDA marketing approval.”
Granier continued, "BioCorRx is committed, through both today’s expanded access filing and our Fast Track application announced July 18, 2023, to meeting our corporate goals of not only getting BICX104 clinical trials promptly completed and obtaining full FDA approval of our product, but also to help those in need now.”
Expanded access (also known as “compassionate use”) is an FDA program that allows drug companies to provide access to an investigational medical product before full FDA approval to patients with a serious or immediately life-threatening disease or condition where standard treatment options have been exhausted or are not suitable. Data published on the FDA website indicates a 98.4% approval rate (62 out of 63) for expanded access applications submitted to the Center for Drug Evaluation and Research (CDER) for treatment protocols between 2018 and 2022.
Granier continued, “We firmly believe that the high and sustained concentrations of naltrexone released by BICX104 hold the potential to significantly curtail opioid overdose deaths, especially considering the emergence of fentanyl as the leading cause of death for 18–49-year-olds as reported by The Washington Post after their analysis of 2021 CDC data. In our study, BICX104 demonstrated a favorable safety profile while delivering therapeutic levels of naltrexone over 84 days, which is three times the duration of the currently marketed 28-day naltrexone depot injection. By providing enhanced relapse protection during the crucial early stages of treatment, BICX104 can make a significant impact on this harrowing crisis."
BICX104, which is being developed by BioCorRx Pharmaceuticals, Inc., the Company’s controlled clinical-stage pharmaceutical subsidiary, is a biodegradable, long-acting subcutaneous pellet of naltrexone for the treatment of OUD being developed with the goal of improving patient compliance to naltrexone therapy compared to other marketed treatments. The BICX104 clinical study was a Phase I, open-label, single-center study in two parallel groups of randomized healthy volunteers to evaluate the PK and safety of BICX104 implantable subcutaneous naltrexone pellets and the marketed once-a-month intramuscular depot naltrexone injection, Vivitrol. 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 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.
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.
About Opioid Use Disorder (OUD)
The leading cause of accidental death in the US is drug overdose. There were ~107,622 drug overdose deaths in 2021. That includes opioid overdose deaths that increased in incidence (and % share) from 42,000 (66%) in 2016 to 82,310 (76%) in 20211,2,3. In addition, there are ~6.4-8.4 non-fatal overdoses per opioid-induced fatality, which lead to long-term physical and mental disability4. On average 226 people die every day from opioid overdose in the US1,7. Opioid overdose can elicit profound CNS-mediated respiratory depression and death. Approximately 25.5 million adults experience severe pain, and as a consequence, opioids have been prescribed more freely since 19995. Indeed, the opioid epidemic began with the over-prescription of opioid painkillers, which caused the supply of prescription opioid analgesic drugs to explode. This has led to the current opioid epidemic which has been designated a public health emergency. More than 2 million Americans have opioid use disorders (OUDs) and most developed their initial addiction with medically prescribed opioid analgesics. The opioid epidemic was calculated to cost the US economy over $504 billion annually, according to a 2017 report by the White House Council of Economic Advisers (CEA)6. This cost is considered low for 2021, given that opioid overdose deaths surged to 82,3107. The OUD epidemic is putting an unprecedented strain on diverse aspects of people’s lives, via morbidity, mortality, health care, the criminal justice system, and families’ potential lifetime earnings and societal contributions. There are few families that have not been affected in some way by this crisis.
1. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2017. Available at http://wonder.cdc.gov.
2. Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths — United States, 2010–2015. MMWR Morb Mortal Wkly Rep 2016;65:1445–1452.
3. CDC: Understanding the Epidemic: https://www.cdc.gov/drugoverdose/epidemic/index.html.
4. Skolnick, P. Treatment of overdose in the synthetic opioid era. Pharmacology & therapeutics 233, 108019 (2022).
5. Kolodny, A., et al. The prescription opioid and heroin crisis: a public health approach to an epidemic of addiction. Annual review of public health 36, 559-574 (2015).
6. The Underestimated Cost of the Opioid Crisis. (White House Council of Economic Advisers (CEA), 2017).
7. Overdose Deaths Accelerating During COVID-19. (CDC).
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 August 15, 2023