Clinical-stage biotechnology company focusing on research and development, development and commercialization of novel formulations and delivery methods of psychedelics to treat mental conditions, neurological and pain disorders PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF) has submitted an application to the U.S Food and Drug Administration (FDA) to receive orphan drug designation (ODD) for using ketamine to treat Status Epilepticus (SE).
Status Epilepticus is a rare neurological disorder which needs emergency treatment of a seizure. The seizure lasts more than five minutes. The company had earlier been grated FDA orphan drug designation for use ketamine to treat complex regional pain syndrome (CRPS) and amyotrophic lateral sclerosis (ALS).
The addition of using ketamine to treat status epilepticus indeed strengthens the company’s pharmaceutical strategy in developing novel uses and delivery methods like the micro-needle patch for ketamine to treat life threatening conditions and rare conditions.
The orphan drug act gives special status to a drug to treat a condition or a rare disease upon the request of a sponsor. This special status is what is referred to as orphan designation or orphan status and the FDA is the body in charge of granting this orphan designation to products which address rare conditions.
“Ketamine has the potential to treat various mental health, neurological and pain disorders, and we are focused on expanding ketamine’s therapeutic utility in rare disorders and life-threatening conditions including, but not limited to, Parkinson’s disease, amyotrophic lateral sclerosis, complex regional pain syndrome, and now status epilepticus. The FDA orphan drug application for ketamine to treat status epilepticus builds on our belief in the potential of ketamine to improve quality of life and to save lives,” said the company’s CEO, Fabio Chianelli.