Supernus (SUPN) Offers Update on Launch of Trokendi, SPN-804
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Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) announced on June 26 that it received a tentative approval letter from the FDA for Trokendi XR™, a 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 NDA and that no additional clinical trials are required. The letter also states that final approval may not be made effective by the FDA until the period of exclusivity protection associated with safety information regarding a specific pediatric population expires.
Since then, the Company has been in discussion with the FDA to clarify which of the three marketing exclusivities (December 2012, June 2013 or July 2014) that are listed in the Orange Book the FDA is referring to and how such exclusivity applies to its NDA. The Company is pleased to provide the following update.
The marketing exclusivity that the FDA is referring to relates to pediatric patients, age 1-24 months. This exclusivity expires on June 22, 2013. Although such age bracket is not part of the patient population for which Trokendi XR will be indicated, the FDA is requesting that such safety information be included in the Trokendi XR label. Therefore, final approval may not be made effective by the FDA until such exclusivity expires.
While the Company continues to discuss this issue with the FDA, it is now planning on launching SPN-804 (extended-release oxcarbazepine) in 1Q 2013, assuming approval in October 2012, and then followed by Trokendi XR in 3Q 2013. This will provide sufficient time between the two product launches to ensure that each launch is optimally resourced. The NDA for SPN-804 is currently under review by the FDA with a PDUFA date of October 19, 2012.
Since then, the Company has been in discussion with the FDA to clarify which of the three marketing exclusivities (December 2012, June 2013 or July 2014) that are listed in the Orange Book the FDA is referring to and how such exclusivity applies to its NDA. The Company is pleased to provide the following update.
The marketing exclusivity that the FDA is referring to relates to pediatric patients, age 1-24 months. This exclusivity expires on June 22, 2013. Although such age bracket is not part of the patient population for which Trokendi XR will be indicated, the FDA is requesting that such safety information be included in the Trokendi XR label. Therefore, final approval may not be made effective by the FDA until such exclusivity expires.
While the Company continues to discuss this issue with the FDA, it is now planning on launching SPN-804 (extended-release oxcarbazepine) in 1Q 2013, assuming approval in October 2012, and then followed by Trokendi XR in 3Q 2013. This will provide sufficient time between the two product launches to ensure that each launch is optimally resourced. The NDA for SPN-804 is currently under review by the FDA with a PDUFA date of October 19, 2012.
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