- Adds to PharmaTher’s existing FDA orphan drug portfolio for Amyotrophic Lateral Sclerosis and Complex Regional Pain Syndrome
- Strengthens commitment to treating rare and life-threatening diseases with ketamine
TORONTO, November 24, 2021 (GLOBE NEWSWIRE) – PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelic biotechnology company, is pleased to announce that it has applied to the United States Food and Drug Administration (“FDA”) to receive the Orphan Drug Designation (“ODD”) for ketamine to treat status epilepticus (“SE”), a rare neurological disorder requiring emergency treatment for a seizure. The Company has received the SDO from the FDA for ketamine to treat amyotrophic lateral sclerosis (“ALS”) and complex regional pain syndrome (“CRPS”). The addition of SE strengthens the Company’s pharmaceutical strategy in developing new uses and delivery methods (i.e. micro-needle patch) for ketamine to treat rare and life-threatening diseases .
SE is a life-threatening occurrence of a prolonged seizure or of recurrent seizures without regaining consciousness between seizures (Lowenstein 1999) lasting more than five minutes. Epidemiological studies have found an annual incidence of SE ranging from 41/100000 to 61/100000 (DeLorenzo 1996). Based on these studies, there are approximately 120,000 to 180,000 episodes of convulsive SE each year in the United States. SE affects individuals of all ages and complicates various neurological and systemic diseases. If ES is not treated immediately, permanent neuronal damage can occur, contributing to high morbidity and mortality rates. Mortality associated with SE is estimated at 17% and can lead to morbidity, including cognitive abnormalities and neurological damage. SE is initially treated with benzodiazepines, of which about 35-45% of patients are refractory to benzodiazepines.
Fabio Chianelli, President and CEO of PharmaTher, said, “Ketamine has the potential to treat a variety of mental health, neurological and painful disorders, and we are focused on expanding the therapeutic utility of ketamine in these disorders. rare 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’s orphan drug application for ketamine to treat status epilepticus is based on our belief in the potential of ketamine to improve quality of life and save lives.
The Orphan Medicines Act grants special status to a drug or biologic to treat a rare disease or condition at the request of a sponsor. This status is called orphan designation (or sometimes “orphan status”). The FDA grants orphan status to products that treat rare diseases, offering incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those that affect fewer than 200,000 people in the United States at any given time. Orphan drug designation would allow ketamine to enjoy certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain testing costs drug clinics, activities, eligibility for orphan drug grants, and the waiver of the FDA new drug application filing fee of approximately $ 2.4 million.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelic biotechnology company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA-approved Phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a new micro-needle patch for intradermal administration of psychedelics and treatments for infectious diseases.
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