FDA Approves Trokendi XR (topiramate) for Migraine Prophylaxis

On April 5, 2017, Trokendi XR (manufactured by Supernus Pharmaceuticals) received final approval from the US Food & Drug Administration. After receiving tentative approval in August 2016, Trokendi XR is now approved for migraine headache prophylaxis in adolescent and adult patients ages 12 years and older.

Trokendi XR is a topiramate product, the most commonly prescribed drug for migraine prophylaxis. Topiramate accounts for over 9 million prescriptions every year, representing approximately 50% of all migraine prophylaxis prescriptions.

Trokendi XR is a once-daily extended release capsule, and can be prescribed for the treatment of epilepsy, as well as migraine prophylaxis. Trokendi XR is available in 25mg, 50mg, 100mg, and 200mg capsules, and should be swallowed whole (not crushed or chewed).

Trokendi XR is indicated for…
● Individuals 12 years and older (as migraine prophylaxis)
● Patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures (as monotherapy)
● Patients 6 years of age and older with Lennox-Gastaut syndrome associated seizures (as adjunctive therapy)

“Trokendi XR…provides full 24 hour coverage for patients…. making it an important new treatment option for adult and adolescent patients suffering from migraine headache. This is an important advancement for patients and another step towards realizing the full potential of Trokendi XR.” – Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals

Some serious side effects can occur with Trokendi XR, including:
● Eye problems, such as eye pressure & blurred vision
● Decreased sweat-production
● Hyperthermia (increased body temperature)
● Metabolic acidosis (acid accumulation in the body)
● Suicidal thoughts
● Cognitive changes
● Kidney stones

Patients who are prescribed Trokendi XR should talk to their doctor about their other medications before beginning treatment. Trokendi XR is not recommended for patients with metabolic acidosis who are also taking metformin. Patients should not drink alcohol 6 hours before and 6 hours after taking Trokendi XR. This medication may not be safe for pregnant women.

Click here for full prescribing and safety information.

For help paying for your Trokendi XR prescription, including co-pay assistance, check out the Supernus Support for Trokendi XR Program.

Reference: “Supernus Receives Final FDA Approval for Trokendi XR for Migraine Prophylaxis in Adults and Adolescents.” NASDAQ. 05 April 2017. Available here.

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