Supernus Pharmaceuticals, Inc.
) recently received final U.S. Food & Drug Administration
(FDA) approval for Trokendi XR for the treatment of epilepsy.
Trokendi XR is a novel once-daily extended release formulation
Johnson & Johnson's
) Topamax (topiramate). This epilepsy product will be launched in
a few weeks.
Along with granting approval, the FDA also agreed to a
deferral of submission of post-marketing pediatric
pharmacokinetic assessments, which were due in 2019, followed by
clinical assessments in 2025. Supernus also got an FDA waiver for
certain pediatric study requirements.
In Jun 2013, Supernus had received tentative approval for
Trokendi XR. Trokendi XR had initially received tentative FDA
approval in Jun 2012. However, at that time, the FDA had said
that final approval depended on the resolution of a marketing
exclusivity issue raised by the FDA regarding a specific
A request for final approval was filed in Dec 2012 along with
a safety data update, a new package insert and packaging
configurations for Trokendi XR. The FDA had informed Supernus
that they will most likely grant this request in the form of a
tentative approval because the review period would be expected to
conclude within the second quarter, prior to the
Jun 22, 2013 expiration of Topamax' pediatric
Supernus has another epilepsy product, Oxtellar XR, in its
portfolio. Oxtellar XR was launched in the U.S. in Feb 2013.
Oxtellar XR was granted three years of marketing exclusivity by
the FDA. The company reported meaningful growth in the Oxtellar
XR prescriber base in the second quarter of 2013, totaling 3,648,
up from 529 in the first quarter. Since its launch, more than
1,100 target physicians have prescribed Oxtellar XR.
Supernus carries a Zacks Rank #2 (Buy). Currently, companies
Questcor Pharmaceuticals Inc.
) look well placed with a Zacks Rank #1 (Strong Buy).
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