SANTA BARBARA, Calif., Nov. 18, 2021
Bexson Biomedical, Inc., a biopharmaceutical company developing subcutaneous treatment platforms for pain management and mental health disorders, today announced it has received pre-IND guidance from the FDA for its lead ketamine compound for acute pain management. With this milestone reached, Bexson is expanding its ketamine development program to address mental health conditions such as Treatment Resistant Depression and Suicidality.
Bexson's patented formulation, BB106, is a ketamine therapy delivered via a wearable, subcutaneous patch pump, in development with leading medical device manufacturer, Stevanato Group. Future clinical trials will test the effect of this drug-device combination 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.
"We are pleased with the clear guidance we received from FDA regarding our preclinical and clinical programs developing BB106," said Gregg Peterson, Bexson Biomedical CEO. "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."
With this guidance in hand, Bexson's team is now applying its BB106 ketamine therapy towards mental health conditions. The company is designing a ketamine therapy with high bioavailability and dynamic dosing profiles that can closely match intravenous ketamine administration. Intravenous delivery of ketamine in depression is reliable and highly validated in research studies, but IV procedural demands have shut out many psychiatrists from this treatment approach. Bexson's therapy, in contrast, could increase provider and patient convenience, and encourage adoption of a differentiated treatment for depression, suicidality and other 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," said Jeffrey Becker, MD, Bexson Biomedical Chief Scientific Officer. "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. By liberating physicians from procedural burdens, I hope that our approach will enable growth of psychotherapeutic support and alliances in the treatment process."
"This may be the future of ketamine treatment in psychiatric care," said Sandhya Prashad, MD, psychiatrist and Medical Director of Houston Ketamine Therapeutics. "This approach can help reduce the costs and expertise needed for IV administration, while still providing the consistency in treatment response that can be lacking with other routes of administration."
Bexson Biomedical, Inc. is a research stage company developing therapies for a wide variety of pain management, addiction and mental health disorders. The company's lead initial indication for its BB106 ketamine therapy is acute pain management. Bexson is also applying its subcutaneous delivery technology to several psychedelic and empathogen compounds. Visit at: www.bexsonbiomedical.com.