FDA approves psilocybin-based orphan drug for Fragile X syndrome
The FDA has approved a new development by Nova Mentis Life Science (Vancouver, Canada). The biotechnolog...
The FDA has approved a new development by Nova Mentis Life Science (Vancouver, Canada). The biotechnology company has developed a psilocybin-based drug in order to treat Fragile X syndrome, implicated to have links to autism spectrum disorder.
The biotech company aims to develop diagnostics and psilocybin-based therapeutics for disorders that are yet to find appropriate treatments. This includes conditions such as Fragile X syndrome, autism spectrum disorder and comorbid depression.
The approval positions Nova Mentis Life Science in a unique position for biotechs, due to established leadership within the field of psychedelic therapy.
It is thought that the non-toxic psilocybin could modulate the immune system and induce anti-inflammatory effects, a novel treatment for such disorders. The outcomes can also include a change in cognition and behavior without leading to adverse effects.
Providing low doses of the psychedelic psilocybin is believed to create a sustainable treatment as a consequence of its anti-inflammatory properties.
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Medicines approved by the FDA as an orphan drug can receive benefits including the ability to ask for research grants from the Office of Orphan Products Development and the capacity to receive regulatory advice from the FDA.
In the future, Nova Mentis Life Science intend to conduct an observational study on autism spectrum disorder approved by an institutional review board. The results of the real-world data generated are hoped to lead to clinical biomarker real-world evidence (RWE). This information is hoped to support a new drug submission concerning the use psilocybin for Fragile X syndrome.
Nova Mentis Life Science will therefore advance their aims of developing psilocybin-based treatments by generating real-world data. Marvin Hausman, Chairman of NOVA’s Scientific Advisory Board, stated that RWE studies can highlight the “potential benefits of a medical product” and reinforced his hopes that by producing real-world data “support of its psilocybin IND [Investigational New Drug] to treat FXS [Fragile X syndrome]” grows in strength.