SANTA BARBARA, Calif., February 1, 2019 – Bexson Biomedical, Inc. today announced that the FDA’s Office of Orphan Products Development (OOPD) granted orphan-drug designation to Bexson Biomedical for the treatment of Complex Regional Pain Syndrome (CRPS) with ketamine.
Orphan designation brings multiple incentives following ultimate FDA marketing approval. These include 7-years exclusivity following approval, a 25% tax credit on trial costs, and waiving of NDA application fees. On average 25% of therapies that receive orphan designation continue on to receive FDA marketing approval.
“We were pleased to see the OOPD grant Bexson orphan status for the treatment of CRPS with ketamine, and with no questions on our application,” said Jeffrey Becker, MD, Bexson’s Chief Scientific Officer. “We look forward to continuing the development of our new formulation of ketamine and to bringing another treatment option for the chronic pain experienced by CRPS patients.”
Bexson Biomedical, Inc. is a research stage company developing ketamine-based therapies for both chronic and acute pain management. Visit at: www.bexsonbiomedical.com.