Supernus Receives Tentative Approval for Trokendi XR(TM)
ROCKVILLE, Md., June 10, 2013 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals,
Inc. (Nasdaq:SUPN), a specialty pharmaceutical company, received a tentative
approval letter from the Food & Drug Administration (the "FDA") for Trokendi
XR™, a novel once-daily extended release formulation of topiramate (formerly
known as SPN-538). The letter states that the FDA completed its review of the
Trokendi XR™ New Drug Application (the "NDA") as amended in December 2012 and
the product is tentatively approved for use as recommended in the submitted
and agreed-upon labeling.
"As expected and as previously communicated, most recently during our May 13,
2013 quarterly earnings call, since this approval was granted before the June
22, 2013 date of expiration of the Topamax® data exclusivity, this approval
came in the form of a tentative approval. We will now submit the "Request for
Final Approval" letter to the FDA based on which we expect to receive Final
Approval and then launch our product, as anticipated, in the third quarter of
2013," said Jack Khattar, Chief Executive Officer, President and Director of
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused
on developing and commercializing products for the treatment of central
nervous system, or CNS, diseases. The Company has one marketed product for
epilepsy, Oxtellar XR^TM (extended release oxcarbazepine), and one tentatively
approved product for epilepsy, Trokendi XR^TM (extended release topiramate).
The Company is also developing several product candidates in psychiatry to
address large market opportunities in ADHD, including ADHD patients with
impulsive aggression. These product candidates include SPN-810 for impulsive
aggression in ADHD and SPN-812 for ADHD.
Forward Looking Statements
This press release contains forward-looking statements regarding the timing of
the availability of Trokendi XR™ to the market. Actual results may differ
materially from those in these forward-looking statements as a result of
various factors, including, but not limited to, risks regarding the Company's
ability to obtain final approval for its products, commercialize its products
successfully, whether physicians will prescribe and patients will use its
products, once available, and competition in their respective markets. For a
further description of these and other risks facing the Company, please see
the risk factors described in the Company's Annual Report Form 10-K that was
filed with the United States Securities and Exchange Commission on March 15,
2013 and under the caption "Risk Factors" and the updates to these risk
factors in the Company's quarterly report form 10-Q that was filed with the
commission on May 15, 2013. Forward-looking statements speak only as of the
date of this press release, and the Company undertakes no obligation to update
or revise these statements, except as may be required by law.
CONTACT: Jack Khattar, President & CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
Press spacebar to pause and continue. Press esc to stop.