Supernus Pharmaceuticals, Inc.
) 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.
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
Currently approved AED drugs include
) Carbatrol and
)'s Keppra XR.
Supernus carries a Zacks Rank #3 (Hold). Right now,
Pernix Therapeutics Holdings, Inc.
) carries a Zacks Rank #2 (Buy).
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