Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, announced that it remains in discussions with the FDA regarding its Supplemental New Drug Application, or sNDA, for migraine.
The FDA requested that the company resubmit the Trokendi XR product label with migraine as an indication in a different format prior to completing its review. No additional new data, studies or analyses for efficacy or safety were requested by the FDA. The company will resubmit the revised label before the end of June, and a new PDUFA date will be assigned by the FDA. At this point, the Company believes that such a PDUFA date is likely to be in the third quarter of 2016.
"Supernus is ready to launch the new indication, and a launch later this year or next year should not have any material effect on our business," stated Jack Khattar, president and chief executive officer of Supernus Pharmaceuticals. "Upon final approval for prophylaxis of migraine headache in adults, we believe Trokendi XR will represent an important new treatment option for adult patients suffering from this condition."
Trokendi XR is the first approved novel once-daily extended release formulation of topiramate for the treatment of epilepsy. Trokendi XR is an antiepileptic drug indicated for initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures; and adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome. The product is available in 25mg, 50mg, 100mg and 200mg extended-release capsules.
