Bexson Biomedical announced today that it received pre-investigational new drug guidance from the FDA for its ketamine compound therapy.

Santa Barbara, California-based Bexson develops the patented BB106 formulation, a ketamine therapy delivered through a wearable, subcutaneous patch pump in development with Stevanato Group.

According to a news release, having reached the milestone of pre-IND guidance, Bexson plans to expand its ketamine development program to address mental health conditions including treatment-resistant depression and suicidality.

“We are pleased with the clear guidance we received from FDA regarding our preclinical and clinical programs developing BB106,” Bexson Biomedical CEO Gregg Peterson said in the release. “FDA approval is a long process, but every milestone reached is one step closer to providing patients with an alternative to opioids for pain management.”

Future clinical trials will test the effect the drug-device combination has in acute pain management as an alternative to opioid pain medications or as an added therapy to lower the need for opioids after serious surgeries, Bexson said. With FDA guidance, the company is now applying BB106 toward mental health conditions.

“Our subcutaneous ketamine formulation and pump technology has been modular by design, allowing us to tune dosing profiles to a variety of mental health conditions as our program advances,” added Bexson Co-Founder & CSO Dr. Jeffrey Becker. “We are designing our parenteral ketamine delivery system to be convenient, controlled and consistent.  This can solve many of the problems that still exist in office-based delivery of ketamine for depression and suicidal ideation, but also for ketamine-assisted trauma therapy.”