San Diego, CA – July 20, 2020 – IRISYS LLC, a pharmaceutical contract development and manufacturing company (CDMO), provides contract development and GMP manufacturing services to BioCorRx Pharmaceuticals, Inc., related to a sterile naltrexone sub-cutaneous implant, also known as BICX102, which is meant to help in the treatment of OUD and the prevention of relapse following opioid detoxification. BICX102 also shows promise for the treatment of alcohol use disorder (AUD).
Opioid addiction is considered a national crisis in the United States that began in the 1990s after a misinformation campaign led by manufacturers to convince doctors that opioids were not addictive. Currently, 21%-29% of prescribed opioids are misused and an average of 128 people die in the US each day due to the misuse of opioids.
In 2019, BioCorRx partnered with IRISYS to develop and GMP manufacture a biodegradable extended-release implant that provides therapeutic naltrexone plasma levels for up to 90 days. BioCorRx and IRISYS believe that an implanted opioid treatment containing naltrexone will be a powerful tool to combat OUD because it is being designed to address the patient non-compliance issues seen with other deliveries of the medication.
“Ending the opioid crisis is about having several options available for doctors and their patients. There is no cure, but certain treatments work better for certain patients. When it comes to BICX102, there is a void in the market for an FDA-approved naltrexone product that lasts multiple months after one administration. This is important as patient non-compliance is a huge issue with addiction treatment, especially treatment using naltrexone as it is an opioid antagonist that is non-addictive,” said Brady Granier, CEO of BioCorRx.
As the contract manufacturer of BICX102, IRISYS is in the formulation and scale-up phase. BICX102 is a biodegradable pellet of naltrexone that is designed to be implanted via minimal procedure into the fatty tissue of a patient typically in the lower stomach region.
Naltrexone belongs to a class of drugs known as opiate antagonists. It works in the brain to prevent opioid effects (e.g., feelings of well-being, pain relief). It can also decrease the desire to take opioids and other substances. This medication is used in other delivery forms (oral and injectable) for OUD and AUD. It is typically used as part of a complete treatment program for substance use disorder (e.g., compliance monitoring, counseling, behavioral contract, and lifestyle changes).
BioCorRx provided the starting formula, manufacturing procedure, and analytical methods. IRISYS performed or will perform analytical method transfer/qualification including microbiology and an extended time dissolution test, engineering batches for process and product evaluation, container closure system evaluation (including short term accelerated stability), sterilization process evaluation, and small scale and clinical supply manufacturing.
“At IRISYS we expect to grow with BioCorRx. As BICX102 advances through the regulatory process to commercial manufacturing, we will be there to support their team in bringing BICX102 to the market,” said Robert Giannini, president, and CSO/CTO of IRISYS, LLC.
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