In an 8-K filing with the Securities and Exchange Commission (:SEC) dated Aug 21, 2013, Supernus Pharmaceuticals, Inc. (SUPN) disclosed its commercial supply agreement with Catalent Pharma Solutions, LLC. The parties joined forces effective Dec 15, 2012, in anticipation of final approval for Trokendi XR in the U.S. Supernus received final U.S. Food & Drug Administration (:FDA) approval on Aug 16, 2013.
Commercial-grade quantities of topiramate, the main ingredient required for Trokendi XR, will be manufactured and provided by Catalent under the agreement.
Catalent will manufacture Trokendi XR as per mutually agreed upon specifications and current good manufacturing practices. Besides this, Catalent will also be responsible for processing, packaging and labeling of Trokendi XR. Supernus will provide the active pharmaceutical ingredient and materials required for manufacturing Trokendi XR.
Trokendi XR is approved for the treatment of epilepsy. 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.
Trokendi XR is a novel once-daily extended release formulation of Johnson & Johnson (JNJ)’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.
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