FDA grants priority review of New Drug Applications (NDAs) for tasimelteon in treatment of Smith-Magenis Syndrome (SMS)

The applications include a supplemental NDA for capsules and an NDA for liquid formulation for the treatment of adults and children, respectively, with SMS, a developmental disorder that is caused by a small deletion of human chromosome 17p 1,2.

SPS commentary:

Patients with SMS present with a number of physical, mental and behavioural problems, the most common symptom of which is a severe sleep disorder associated with significant disruption in the lives of patients and their families.


In the EU, tasimelteon was approved for treatment of non-24-Hour sleep-wake disorder in totally blind adults in May 2019, but there is currently no indication of whether there are launch plans for UK.


Biospace Inc.