Supernus Pharmaceuticals, Inc. (SUPN) 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 (JNJ)’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 exclusivity.
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 million.
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.
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