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FDA approves Trokendi XR for migraine prophylaxis in adolescents, adults
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The FDA has approved Supernus Pharmaceuticals' supplemental new drug application requesting a label expansion for Trokendi XR to include migraine headache prophylaxis in adults and adolescents aged 12 years and older, according to a press release.
Supernus was granted provisional approval last summer with final approval contingent upon pediatric exclusivity of the drug in adolescents, which expired last week.
"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," Jack Khattar, president and CEO, Supernus Pharmaceuticals, said in the release. "This is an important advancement for patients and another step toward realizing the full potential of Trokendi XR."
Trokendi XR capsules will be available in strengths of 25 mg, 50 mg, 100 mg and 200 mg. According to the drug’s website, serious adverse events include loss of muscle coordination, dizziness, effects on thinking and alertness, low body temperature, kidney stones and high blood ammonia levels.
In addition to this latest indication, Trokendi XR can be taken as adjunctive therapy in patients aged 6 years and older with seizures associated with the epileptic condition known as Lennox-Gastaut syndrome and partial-onset or primary generalized tonic-clonic seizures. It can also be taken as initial monotherapy in patients aged 6 years and older with partial-onset or primary generalized tonic-clonic seizures, according to the press release.
This is the second recent FDA approval regarding a migraine drug. Last week, the agency approved two supplemental new drug applications for Qudexy XR (topiramate, Upsher-Smith Laboratories Inc.) extended-release capsules, a once-daily prophylactic medication for migraine headache in adults and adolescents aged 12 years and older.
Disclosure: Khattar is president and CEO of Supernus Pharmaceuticals.
Reference: Epilepsy Foundation's page on Lennox-Gastaut Syndrome (Accessed 04-06-2017.)