Psychedelic biotechnology company focused on research, development and commercialization of novel psychedelic compounds PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF) announced having being granted orphan drug designation (ODD) by the U.S Food and Drug Administration (FDA) for ketamine to treat Status Epilepticus (SE).
Status Epilepticus is a rare neurological condition which requires emergency treatment. In essence, SE is a life threatening occurrence of a prolonged seizure or recurrent seizures without recovery of consciousness between seizures lasting for more than five minutes.
The ODD to treat status epilepticus will indeed expand the company’s current FDA ODD portfolio for ketamine to treat amyotrophic lateral sclerosis and complex regional pain syndrome.
In addition, the FDA ODD will also strengthen PharmaTher’s strategy in developing novel uses and delivery methods like the micro-needle patch for ketamine to treat life threatening conditions and rare disorders.
The Orphan Drug Act gives special status to a drug or biological product to treat a rare condition upon request from a sponsor. The FDA grants orphan drug status to products which treat rare diseases providing incentives to sponsors developing drugs or biologics.
“Studies have shown the potential of ketamine to treat various mental health, neurological and pain disorders. We are focused on becoming the leader for providing novel ketamine solutions and our dedication in 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 puts us on the right path in making ketamine more available to improve quality of life and to save lives,” said the company’s CEO, Fabio Chianelli.