PharmaTher, a Toronto-based biotechnology company focused on discovering and developing drugs using Ketamine, received an Orphan Drug Designation (ODD) for a ketamine-based medicine to treat a rare seizure condition.
Status Epilepticus is characterized by a seizure lasting more than five minutes or having more than one seizure in a five-minute period, according to HopkinsMedicine.org. While all seizures can be dangerous, these are considered extremely severe and can lead to permanent brain damage and even death.
This designation is not PermaTher’s first ODD designation, the company previously received ODDs for its ketamine therapy for amyotrophic lateral sclerosis and complex regional pain syndrome.
“Studies have shown the potential of ketamine to treat various mental health, neurological and pain disorders,” PermaTher CEO Fabio Chianelli said. “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.”
What Is an ODD?
The FDA grants orphan status to products that treat rare diseases, providing incentives to companies working on therapies for rare diseases. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time.
Orphan drug designation would qualify ketamine for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, tax credits for certain clinical drug testing costs and a waiver of the FDA New Drug Application filing fee of approximately $2.4 million.
