The US FDA has approed the Orenitram (treprostinil), extended-release tablets for the treatment of pulmonary arterial hypertension (PAH) in WHO Group I patients to improve exercise capacity.

Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company, developed the extended release formulation of Orenitram under a Development and License Agreement with United Therapeutics Corporation. The product uses EnSoTrol, Supernus' novel osmotic technology platform. Per the license agreement between Supernus and United Therapeutics, United Therapeutics will pay Supernus certain milestone fees and royalties associated with the commercialization of the product worldwide.

"This is a very exciting development for Supernus, our partner United Therapeutics and patients with PAH. This approval is the first of its kind for an oral prostacyclin analogue for any disease. An orally administered prostacyclin analogue offers patients and physicians more treatment choices. We look forward to the launch of the product by United Therapeutics and are very pleased to be a part of such a novel advancement with our EnSoTrol technology," said Jack Khattar, chief executive officer, president and director of Supernus.

Orenitram is a trademark of United Therapeutics Corporation.

Supernus Pharmaceuticals, Inc. is focused on developing and commercializing products for the treatment of central nervous system, or CNS, diseases.