Supernus Pharmaceuticals, Inc.
) recently received tentative US Food & Drug Administration
(FDA) approval for Trokendi XR. Trokendi XR is a novel once-daily
extended release formulation of
Johnson & Johnson
)'s Topamax (topiramate). The company pointed out that the
agency's approval was a tentative approval as the same was
granted before the expiry of data exclusivity on Topamax.
Trokendi XR, an epilepsy candidate, 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 pediatric population.
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
June 22, 2013 expiration of Topamax's pediatric
Supernus intends to submit a "Request for Final Approval"
letter to the FDA and launch the candidate in the third quarter
of 2013 after receiving final approval.
Supernus has another epilepsy product, Oxtellar XR, in its
portfolio. Oxtellar XR was launched in the US in Feb 2013.
Oxtellar XR was approved by the FDA in Oct 2012. Oxtellar XR was
granted three years of marketing exclusivity by the FDA. As of
Mar 31, 2013 net deferred product revenue amounted to $3.6
The company reported meaningful growth in the Oxtellar XR
prescriber base so far in the second quarter of 2013. In the
first two months of its launch, prescriptions totaled 579.
Supernus carries a Zacks Rank #3 (Hold). Other companies like
Salix Pharmaceuticals Ltd.
) look more attractive with a Zacks Rank #1 (Strong Buy).
JOHNSON & JOHNS (JNJ): Free Stock Analysis
SALIX PHARM-LTD (SLXP): Free Stock Analysis
SANTARUS INC (SNTS): Free Stock Analysis
SUPERNUS PHARMA (SUPN): Free Stock Analysis
To read this article on Zacks.com click here.