The United States Food and Drug Administration (FDA) has approved United States-based Vanda Pharmaceuticals Inc's (Nasdaq: VNDA) HETLIOZ (tasimelteon) capsule and liquid formulations intended for the treatment of adults and children, respectively, with night-time sleep disturbances associated with Smith-Magenis Syndrome (SMS), it was reported on Tuesday.

The product is the first FDA-approved medication for patients with SMS. HETLIOZ capsules will immediately be available for adults with SMS, while the HETLIOZ LQ liquid formulation, for children with SMS is likely to be offered in the first quarter of 2021.

The approval was based on a single placebo-controlled efficacy study in this disorder that studied both adults with SMS taking the HETLIOZ capsule and children with SMS taking the liquid formulation. The safety profile of HETLIOZ in this study was similar to those seen in HETLIOZ studies earlier conducted for the treatment of Non-24-Hour Sleep-Wake Disorder, and was similar between adults and children with SMS.

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