Life science company focusing on developing a psilocybin based therapeutics and complementary diagnostics for neuroinflammatory disorders Nova Mentis Life Science Corp. (CSE: NOVA) (OTCQB: NMSLF) announced having submitted an application to U.S Food and Drug Administration (FDA) to get orphan drug designation for its proprietary psilocybin drug which treats patients with fragile X syndrome (FSX).
The fragile X syndrome is the most common inherited cause of autism spectrum disorder (ASD). The U.S Orphan Drug Act gives special status to a drug for treatment, diagnosis and prevention of rare diseases or conditions.
“NOVA is committed to accelerating the research and development of psilocybin-based therapeutics to help treat fragile X syndrome. With FDA orphan drug designation, our Company would qualify for benefits and incentives such as seven years of market exclusivity after drug approval, tax credits for clinical testing, eligibility for orphan drug grants and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million,” said the company’s president and CEO, Will Rascan.
Rascan further added that last month the company also filed for orphan drug designation with European Medicines Agency (EMA). The company says that new clinical treatments for FXS are needed as it believes serotonergic agonists like psilocybin represent promising option with a great potential.