SAN DIEGO, July 27, 2020 /PRNewswire/ -- IRISYS LLC, a
pharmaceutical contract development and manufacturing company
(CDMO), provides contract development and GMP manufacturing
services to BioCorRx Pharmaceuticals, Inc., for a sterile
naltrexone sub-cutaneous implant, also known as BICX102, which is
meant to help in the treatment of opioid use disorder (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 1990's
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 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," 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 a minor
procedure into the fatty tissue of a patient typically in the lower
abdominal 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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SOURCE IRISYS LLC