Supernus’ sNDAs receive final FDA approval for Trokendi XR for migraine prophylaxis


Supernus Pharmaceuticals has received the final approval from the US Food and Drug Administration (FDA) for its supplemental new drug applications (sNDAs) requesting a label expansion for Trokendi XR.

The label expansion for Trokendi XR is to include prophylaxis of migraine headache in adults and adolescents aged 12 and older.

In August last year, Supernus secured tentative approval for one of the two sNDAs.

The Topiramate drug is used to treat migraine prophylaxis and is the most prescribed drug with more than nine million prescriptions a year, representing about 50% of all IMS prescriptions written for migraine prophylaxis.

Supernus Pharmaceuticals president and CEO Jack Khattar said: "This approval and our imminent launch in migraine represent an opportunity for Supernus to further strengthen its leadership position in this market with Trokendi XR.

"This approval and our imminent launch in migraine represent an opportunity for Supernus to further strengthen its leadership position in this market with Trokendi XR."

“Trokendi XR, with its novel formulation, provides full 24-hour coverage for patients with smooth pharmacokinetics compared to the immediate-release topiramate products, making it an important new treatment option for adult and adolescent patients suffering from migraine headache."

The once-daily extended release formulation of topiramate, Trokendi XR, is also used to treat epilepsy.

The drug is available in 25mg, 50mg, 100mg and 200mg extended-release capsules.

Supernus has two marketed products for epilepsy, Oxtellar XR (extended-release oxcarbazepine) and Trokendi XR (extended-release topiramate).

It is also developing several product candidates such as SPN-810 for the treatment of impulsive aggression in ADHD patients and SPN-812 for the treatment of ADHD.