Brady Granier, the President and Director of BioCorRx, chatted with Digital Journal’s Markos Papadatos about a new addiction treatment, BICX104, currently being developed by BioCorRx Pharmaceuticals for potential FDA approval and America’s landscape with the national opioid epidemic.
During his tenure at Clear Channel Media & Entertainment (CCME), now iHeartMedia, Granier served in many roles over the years, most notably as the Healthcare Category Manager. CCME is one of the largest media companies in the U.S.
Much of Granier’s focus was helping to develop marketing campaigns for healthcare-related clients, as well as for national brands including, but not limited to Neutrogena, New Line Cinema, Paramount Pictures, Samsung, AT&T, Coke, Dr. Pepper, Hansen’s, Honda, MGM, Universal Studios, and more.
With an extensive background in nursing, Granier also moonlighted as a home health nurse, critical care transport nurse, and TV studio set medic, spending most of his nursing years in healthcare as the charge nurse in the emergency room at White Memorial Hospital downtown Los Angeles.
Overdose Deaths Are At An All-Time High
Right now, overdose deaths in the United States are at a record level, with last year’s estimates reported to have topped 90,000 – an increase of 27% from the previous 12 months and a record for the most such deaths in a single year, according to the Centers for Disease Control and Prevention (CDC).
Medication-Assisted Treatment and a New Form of Opioid Use Disorder Treatment
For those familiar with medication-assisted treatment, or MAT, which is a combination of medication and therapy for substance use disorder, there are a variety of medications commonly used to help people prevent cravings, bounce back from an overdose, and/or better manage their daily substance use problem.
“Everyone knows the drug Narcan for overdose reversal, but that’s not necessarily the right treatment for people who need to fight cravings. It’s an overdose agent,” Granier explained. “The few drugs that are used more commonly to treat opioid use disorder are Methadone, Suboxone, and Naltrexone, or Vivitrol” – all of which, according to Granier, have utility based on the patient’s situation.
Methadone is more closely related to heroin itself than any other treatment form. It’s an accepted, longer-lasting, harm-reduction treatment that has been around for decades.
The big move has been more towards buprenorphine, which is a partial agonist. It’s more closely related to methadone than naltrexone as they are both opioids and can lead to withdrawals if discontinued. However, they all occupy the same receptors in the brain, which can help prevent overdose.
Naltrexone is the medication that BioCorRx works with, which is effective for opioids and alcohol. It has been around for decades and has been approved several times by the FDA in different forms. It works by blocking the receptors in the brain that opioids bind to as well. So, if you have sufficient therapeutic levels of naltrexone in your system, then the opioids can’t bind with those receptors, making you much less likely to get high or overdose.
Naltrexone Currently Lacks Compliance, Here’s a Solution
Unfortunately, with some forms of naltrexone, compliance can be a significant issue. Most patients, in general, tend to be non-compliant with any prescribed by their doctor, due to substance use disorder and the intrusive cravings that often derail the recovery.
“It was originally as a day one a daily pill, so it works very well if you take it,” Granier said. “However, most individuals aren’t very compliant with taking prescriptions for anything, for that matter.”
Suppose you look at Vivitrol, an injectable form of naltrexone approved in 2005 and 2006. It provides patients with one-month coverage of naltrexone after one shot. “This is better because someone decides to get a shot, and it lasts for 30 days. The problem, however, is that it doesn’t last long enough because 30 days is usually not long enough to change environments, behaviors, and go through therapy or whatever other recovery tools one is using.”
For these reasons, Granier and the BioCorRx team have come up with a three-month delivery method of naltrexone, an implantable pellet called BICX104, with one significant difference:
“…ours has subcutaneously implanted in the belly flat; a minor procedure,” which Granier describes as “much like someone getting hormone replacement therapy via pellets. It’s a large pellet that goes into the patient’s belly fat and should dissolve over three months.”
And it is that three-month product that BioCorRx is looking for FDA approval significant already has received nearly $9.2 million from the National Institutes of Health (NIH) and the National Institute on Drug Abuse (NIDA) to undertake a variety of preclinical and clinical studies on it to advance it toward FDA approval. They are currently preparing for their first-in-human study.
“This is an essential project for both organizations, and since we received the initial funding in 2019, we were finally able to achieve clearance from the FDA earlier this year to begin our human trials.”
BICX104 is a biodegradable, long-acting subcutaneous pellet of naltrexone developed in collaboration with the NIDA/NIH, under RFA DA-19-002. We learned that the medication is designed to overcome substantial non-compliance issues seen with other drugs on the market to battle substance use disorder under the company’s pharmaceutical subsidiary, BioCorRx Pharmaceuticals, to which Granier serves as CEO.
“The FDA’s communication that we are safe to proceed to our human study represents a major milestone for BICX104,” Granier said. “We are looking forward to beginning the first-in-human clinical trial of BICX104, which will assess longevity, safety, and tolerability of BICX104.”
Both Granier and recent CDC data acknowledge that the COVID-19 pandemic has been a significant driver in the high volume of drug overdose deaths. “[It] had overshadowed the opioid epidemic, which unfortunately seems to have worsened over the last year,” Granier explained. “Our main goal is to bring this important medication to the masses, and we hope that [it] can one day soon be available to help those in need.”
Bottom Line
We need all the help we can get to reduce the number of people in America becoming addicted to alcohol or opioids. It seems that BioCorRx’s BICX104 is here to help those who have unfortunately already become addicted. Speaking about BICX104, Granier says that if the company “can give someone a few months of therapeutic coverage after one administration,”
that the “[patient] should 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.”
