First Trials Set to Begin for BICX104, An Unprecedented Way for Patients to Receive Naltrexone
BICX104 is a biodegradable, implantable pellet that can be used for the treatment of various substance abuse disorders.
There has undoubedtly been impressive progress made in the past decade in the world of addiction recovery services.
Yet the numbers of lives lost are still harrowing.
According to the CDC, there were 75,673 opioid-related overdose deaths from April 2020 to April 2021, a near 20,000 increase from the 12-month period prior.
The company announced today that it has begun the process of recruiting and enlisting volunteers for the first-ever clinical trial of the highly-anticipated BICX104.
BICX104 is an unprecedented way for patients to get and take Naltrexone, a medication that is most popularly used for the treatment of addiction to alcohol and opioids, though its effects are used in treatment for a multitude of addictive disorders such as binge eating disorder.
Naltrexone has historically had two options for usage. It can be taken orally in a pill form but it typically is taken as a slow-release injectable, especially for the usage of treatment in opioid addiction. Naltrexone works by blocking the euphoric effects of alcohol, opioids, whatever it may be by binding to specific receptors (endorphin, opioid, etc.) in the body associated with the “high” that specific substances or behaviors correlate with.
But since taking the medication in both these routes are voluntary, patients who do not wish to take the medication will not benefit from the effects of it, making it a difficult way to manage recovery if the patient does not agree to or want to use the medicine in conjuction with other holistic methods, such as CBT sessions.
But with BICX104, patients in recovery won’t have the option each day — the new medication will be an implantable pellet of Naltrexone that is biodegradable, the effects of which to be absorbed intramuscularly in each patient’s body.
“This is an extremely important milestone as it marks the next phase of development for BICX104,” Brady Granier, President, Director of BioCorRx Inc. and CEO of BioCorRx Pharmaceuticals Inc. said upon the beginning of trial recruitment. “This study 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. We strive to enroll all subjects as soon as possible and look forward to providing progress updates as they become available.”
The study, which will be lead by Dr. Joel M. Neutel M.D., Director of Research at the Orange County Research Center Orange County Research Center (OCRC), is the first of its kind that will survey the safety and pharmacokinetics of the pellet in a group of random, healthy volunteers.
Patient 0 trials for BICX104 are set to begin next month.
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