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Trial Begins for Skin-Implanted Addiction Therapy

Ambulance at night

(Ildar Sagdejev, Wikimedia Commons.

27 Apr. 2022. A clinical trial is underway testing a therapy for opioid use disorder that places a treatment drug pellet under the skin lasting for 12 weeks. The study is sponsored by BioCorRx Inc. in Anaheim, California, creator of the addiction therapy code-named BICX104 assessed in the trial.

BioCorRx Pharmaceuticals, the company’s drug-making subsidiary, is developing BICX104 as a treatment for opioid addiction, while the epidemic of addiction and overdoses in the U.S. continues to rage. According to data from 2019 collected by Department of Health and Human Services, 1.6 million people in the U.S. reported an opioid addiction, out of 10.1 million Americans misusing prescription opioids in the previous year. That same year, more than 70,600 people died of drug overdoses of all kinds, with about 48,000 dying from synthetic opioids, such as fentanyl in the year ending June 2020, and almost 14,500 dying from a heroin overdose.

While medication-assisted treatments are available for opioid use disorder, those therapies are not yet widely used. As reported by Science & Enterprise in Sept. 2019, a study conducted by the Mayo Clinic found three drugs approved by FDA for opioid use disorder — naltrexone, buprenorphine, and methadone — are prescribed to only 11 percent of patients. A problem with prescribing these drugs is compliance. They require either frequent dosing or administration in clinics, which limits their use among a population often plagued by troubled lives.

Designed for opioid and alcohol abuse

BICX104, says BioCorRx, is made to address some of these concerns. Its active ingredient is naltrexone that blocks opioid receptors and helps deter further opioid use. The medication is normally given with a syringe as an intramuscular injection and requires complete abstinence from opioids. Any reduction in compliance with treatments or break in abstinence can trigger a relapse.

In this case, BICX104 is given as a naltrexone pellet, injected under the skin and designed to last for 12 weeks. The company says naltrexone is dispensed through the blood stream and biodegrades over that period. In addition, the pellet can be removed easily if needed. BICX104 is being developed as a treatment for opioid and alcohol abuse, with $5.7 million in funding from National Institute on Drug Abuse, part of National Institutes of Health. Earlier this month, the company received a supplemental $100,000 award from NIDA for further development of BICX104.

BioCorRx says the early-stage clinical trial started enrolling 24 healthy adult volunteers at Orange County Research Center, a clinical trial site in Tustin, California. Participants are randomly assigned to receive a BICX104 pellet under the skin to last for 12 weeks, or a syringe injection of the FDA-approved drug Vivitrol with naltrexone given every four weeks in that time. Participants are tracked for 20 weeks looking for levels and changes in concentrations of naltrexone in blood plasma, as well as signs of adverse effects for 24 weeks.

“This study,” says Brady Granier, CEO of BioCorRx Pharmaceuticals in a company statement, “will help evaluate the pharmacokinetics and safety of BICX104 compared to another marketed naltrexone product. We believe that better compliance to naltrexone therapy will ultimately lead to better patient outcomes.”

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