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Expanded FDA Approval for Trokendi XR

Supernus news release; 2017 Apr 5

Supernus Pharmaceuticals, Inc. has announced that the US Food and Drug Administration (FDA) has granted final approval to the company's Supplemental New Drug Applications (sNDAs) requesting a label expansion for Trokendi XR to include prophylaxis of migraine headache in adults and adolescents aged ≥12 years. Supernus Pharmaceuticals, Inc. is headquartered in Rockville, MD.

Dosage/administration: The recommended dosage is 25 mg once daily, administered for the first week. Dosage should then be increased weekly by 25 mg increments to achieve desired clinical outcome. Capsules should be swallowed whole and should not be sprinkled on food, chewed, or crushed.

Adverse reactions: The most common adverse reactions at recommended dosing in adult and adolescent controlled migraine clinical trials were paresthesia, anorexia, weight decrease, difficulty with memory, taste perversion, upper respiratory tract infections, abdominal pain, diarrhea, hypoesthesia, and nausea.

Citation:

Supernus receives final FDA approval for Trokendi XR® for migraine prophylaxis in adults and adolescents. [news release]. Rockville, MD: Supernus Pharmaceuticals, Inc. April 5, 2017. http://ir.supernus.com/releasedetail.cfm?ReleaseID=1020364. Accessed April 13, 2017.

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