Oxtellar XR Launched by Supernus

Supernus Pharmaceuticals, Inc. (SUPN - Snapshot Report) recently announced the launch of its antiepileptic drug, Oxtellar XR, in the US. Oxtellar XR was approved by the US Food and Drug Administration (FDA) in Oct 2012. Supernus’ 75-person sales force has started promoting the product.

Oxtellar XR is a novel once-daily extended release formulation of oxcarbazepine. Oxtellar XR is an antiepileptic drug (AED) indicated for adjunctive therapy for the treatment of partial seizures in adults and in children 6 to 17 years of age.

In Nov 2012, Supernus received three years of marketing exclusivity from the FDA.

Supernus has another epilepsy product named Trokendi XR, which received tentative FDA approval in Jun 2012. Supernus is likely to launch this product in the third quarter of 2013 provided it gains final approval from the FDA.

Our Take

The launch of Oxtellar XR is a significant milestone for the company. Supernus’s main area of focus is the development of products for central nervous system (CNS) disorders. The company’s pipeline includes SPN-810 (completed phase IIb) for the treatment of impulsive aggression in attention deficit hyperactivity disorder (ADHD) patients and SPN-812 (completed phase IIa) for ADHD.

In Nov 2012, the company announced encouraging top-line results from a phase IIb study on SPN-810, across three doses. The company plans to advance the candidate into phase III trials and will meet the FDA to discuss the trial design and protocol for the same.

Currently approved AED drugs include Shire plc’s (SHPG - Snapshot Report) Carbatrol and UCB (UCBJF)’s Keppra XR.

Supernus carries a Zacks Rank #3 (Hold). Right now, Pernix Therapeutics Holdings, Inc. (PTX - Snapshot Report) carries a Zacks Rank #2 (Buy).