BioCorRx (OTC:BICX) said late last week it scheduled a pre-investigational new drug meeting with the FDA for its BICX102 naltrexone implant for next January as the company works on an IND application for the implant.
The Anaheim, Calif.-based company said that its scheduled pre-IND meeting will not preclude it from submitting its IND application before that date.
“While we would have hoped for an earlier meeting date with the FDA, we cannot control their timeline and it does not stop our progress as we still need the CMC portion of the package completed. That work is already in progress so that no time is wasted while we wait for the pre-IND meeting in the event we cannot submit the IND application prior to the meeting. Our desire remains to be able to go to human trials as quickly as possible by submitting the IND application. We do not want to rush things and submit something that’s incomplete in the eyes of the FDA. It’s also important to note that there is strong interest in this product from various government entities which has helped fuel our decision to get this product approved. We have been in discussions or meetings with ONDCP, NIDA, NIAAA, DoD, SAMHSA, some state DOCs, and others to explore opportunities for assistance in bringing this product to market. We believe that the medical community and government entities have a clear desire for an antagonist therapy that can last several months to fight this opioid epidemic. We feel that this product can save many lives once approved and, as a result, payers from different sources will emerge following approval,” BioCorRx CEO Brady Granier said in a press release.
“BioCorRx and ISS are working to finalize a comprehensive meeting package that includes a robust plan to demonstrate a scientific bridge. Given the national opioid epidemic, we believe we have developed a strong justification for why we believe the available data can and should be leveraged to expedite the IND review. We anticipate a productive conversation with the FDA,” ISS head of clinical and regulatory support Steven Weisman said in a prepared statement.
“We have the clinical and toxicology data that we feel will be sufficient for the application, and we are now completing the CMC information which involves agreements with drug suppliers and manufacturers. The implant must be made by a cGMP facility and we are negotiating with several FDA licensed contract manufacturers at this time. We are also close to finalizing commitments from manufacturers of the ingredients in the implant with drug suppliers that have open drug master files with the FDA. Once we have the CMC portion of the package in place, I feel we will be in a good position to file the IND,” BioCorRx drug development VP Dr. Bal Brar said in prepared remarks.
In June, BioCorRx said it partnered with the Virtual Reality Medical Center to conduct a study on the company’s long-lasting naltrexone implant.
