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FDA Approves New Treatment For Migraine In Adults


Adults suffering with acute and immediate attack of migraine now have a new treatment option with the approval of Ubrelvy (ubrogepant) by the U.S. Food and Drug Administration.

Allergan USA, Inc.'s Ubrelvy tablets are approved to treat migraine with or without aura - a sensory phenomenon or visual disturbance, in adults. However, it is not indicated for the preventive treatment of migraine.

In a statement, the FDA noted that the drug is the first one in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.

Migraine is a neurologic disease characterized by recurrent episodes of moderate-to-severe headache. It comes with additional symptoms of nausea and/or vomiting and sensitivity to light and sound. The reasons behind migraines could be stress, hormone changes, bright or flashing lights, lack of food or sleep and diet.

Migraine affects more than 10 percent of people worldwide, and an estimated 37 million people in the U.S. Among these, around one third people also experience aura shortly before the migraine that can appear as flashing lights, zig-zag lines, or a temporary loss of vision.

Ubrelvy's effectiveness to treat migraine was demonstrated in two randomized, double-blind, placebo-controlled trials. In these studies, 1,439 adult patients with a history of migraine, with and without aura, received the approved doses of Ubrelvy to treat an ongoing migraine.

The FDA further said Ubrelvy is contraindicated for co-administration with strong CYP3A4 inhibitors.

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