The implant slowly releases naltrexone, a non-addictive opioid antagonist that can reduce physical cravings and block some of the effects of alcohol and opioids, the Los Angeles-based company said.
“While we continue to observe positive results in our practice, currently the FDA has not given a specific approval for the administration of naltrexone by having it implanted under the skin. Vivitrol, the first FDA approved 30-day injectable form of naltrexone, has led to meaningful market penetration, demonstrating strong demand for this application. Furthermore, with the recent approval of Probuphine by the FDA, implants to treat addiction in general are getting more exposure. Our objective is to expand the addressable market for our treatment targets and seeking FDA approval for our naltrexone implant is a logical next step. To support this endeavor, we anticipate announcing strategic relationships with experienced FDA advisors and consultants in the near term and will provide further details as our strategy unfolds.,” CEO Brady Granier said in a prepared statement.
The initiative is being funded by a previously announced $2.5 million investment from Alpine Creek, BioCorRx said. The company also plans to use the R&D platform to evaluate other compounds to expand its pipeline of addiction treatment services.