FDA Clears BICX104 Implantable Gradual-Release Naltrexone Pellet for In-Human Clinical Trials

First Posted: Jul 22, 2021 02:55 PM EDT
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Opioid use disorder (OUD) continues to rise in the wake of COVID-19 and growing economic uncertainty, per the Centers for Disease Control (CDC), and now significantly impacts over 16 million individuals worldwide. Alcohol Use Disorder (AUD) is also increasing amongst American adults.

Designed to help provide much-needed medical relief, leading substance use disorder treatment provider BioCorRx recently received U.S. Food and Drug Administration (FDA) clearance to commence in-human clinical trials of its BICX104 solution later this year. An implantable, biodegradable, and long-lasting gradual-release Naltrexone pellet being developed in collaboration with the National Institute of Drug Abuse (NIDA), BICX104 progressively releases medication over time that helps individuals who struggle with OUD and AUD from engaging in continuing use of opiates or alcohol.

"There's a clear unmet need for a subcutaneous Naltrexone product that lasts months instead of a day," notes BioCorRx president and director Brady Granier. "BICX104 is designed to overcome substantial non-compliance issues seen with other medications on the market to battle substance use disorder. If we can give someone a few months of therapeutic coverage after one administration, we feel they will have a better chance of working on the behavioral side of their disease without the intrusive cravings that often sidetrack one's journey in recovery."

By reducing appetite for alcohol or opioids, BICX104 aims to improve AUD and OUD sufferers' ability to focus on cognitive treatment methods and make more lasting and positive behavioral or lifestyle changes. Incorporated as part of a comprehensive drug or alcohol abuse treatment program, it hopes to reduce chances of users relapsing while also improving their ability to concentrate on addressing the underlying roots of these diseases rather than struggle with day-to-day symptoms. Such advancements may prove especially timely, with recent analyses by The Commonwealth Fund noting that overdose deaths likely topped 90,000 in the United States alone given economic shock, social isolation, and heightened mental health concerns brought on by (and reduced access to medical care due to) the pandemic.

However, as with any potential new substance abuse treatment method, it will also be necessary to educate the public on BICX104's efficacy and upsides, notes Granier. Part of these efforts, he acknowledges, include addressing common misunderstandings and misapprehensions. "There are many misconceptions, most unwarranted, about addiction treatment medications. One is that we shouldn't treat drug or alcohol addiction with another drug, but that's often based on lack of education on the mechanism of action for these medications. BICX104 is comprised of naltrexone, which is not addictive and does not cause withdrawal symptoms when discontinued. There is no abuse and diversion potential so it basically has no 'street value.'"

The company has certainly done its homework and advance planning in the run up to FDA trials. Not only has BioCorRx been developing addiction treatment programs for over 10 years and - via this experience, as well as its relationships with board-certified addiction treatment specialists - gained significant knowledge surrounding the opioid and alcohol epidemics. It's also acquired and created several formulas for implantable Naltrexone over the years, only eventually arriving at BICX104 after engaging in a process of rigorous research and development.

"Our next step is to start human trials," says Granier. "We recently received our IND clearance from the FDA in May 2021 to proceed to the first human trial of BICX104. We plan to start that later this year. We are seeking a 505(b)(2) approval pathway for this product, which is an abbreviated pathway since Naltrexone has been approved multiple times for different indications and routes of delivery. We feel that the studies toward approval will be relatively small compared to traditional approval pathways."

Noting this, BioCorRx expects to proceed to direct distribution upon receiving FDA approval, though partnership with another pharmaceutical provider still remains a possibility. "We're looking forward to beginning the first in-human clinical trial of BICX104," Granier says. "Our main goal is to bring this important medication to the masses, and we hope that BICX104 can one day soon be available to help those in need."

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