Ubrelvy Approved to Treat Migraines

December 23, 2019 – The U.S. FDA has approved UbrelvyTM (ubrogepant) tablets, manufactured by Allergan, to provide acute treatment of migraine with or without aura in adults. Ubrelvy is the first drug in the calcitonin gene-related peptide (CGRP) receptor antagonist class approved for the acute treatment of migraines.

Migraine is a neurological condition and pain disorder that affects approximately 31 million people in the United States. It is best known for causing severely painful, debilitating headaches, but symptoms can also include nausea, sensitivity to light and sound, difficulty speaking, and numbness or tingling. Migraine attacks can be triggered by a wide variety of circumstances, including stress, anxiety, hormonal changes, missed meals, changes in the weather, and more. These attacks can last for hours or days and can be debilitating. CGRP receptor antagonists like Ubrelvy are thought to help treat the condition by blocking the CGRP protein, which is released during migraine attacks, from bonding with receptors in the body.

In clinical trials, a significantly greater percentage of patients who received Ubrelvy achieved freedom from pain and their most bothersome migraine symptoms (nausea, light sensitivity, and sound sensitivity) two hours after treatment compared to patients who received a placebo. Nearly a quarter (23%) of patients who participated in the trials were also on a preventive medication for migraine.

The recommended dosing for Ubrelvy is 50mg or 100mg taken by mouth as needed. If necessary, a second dose can be administered at least two hours after the initial dose. Dosing should not exceed 200mg in a 24-hour period and should be reduced in patients who have severe hepatic or renal impairment. Unlike other CGRP receptor antagonists, Ubrelvy is not approved to prevent migraines.

Allergan has launched Ubrelvy at a wholesale acquisition cost of $850 per box of 10 tablets.