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General Information
Ubrelvy (ubrogepant) is a calcitonin gene-related peptide receptor antagonist.
Ubrelvy is specifically indicated for the acute treatment of migraine with or without aura in adults.
Ubrelvy is supplied as a tablet for oral administration. The recommended dose of Ubrelvy is 50 mg or 100 mg taken orally with or without food.
If needed, a second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established.
Mechanism of Action
Ubrelvy (ubrogepant) is a calcitonin gene-related peptide receptor antagonist.
Side Effects
Adverse effects associated with the use of Ubrelvy may include, but are not limited to, the following:
- nausea
- somnolence
Clinical Trial Results
The FDA approval of Ubrelvy was based on 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. In both studies, the percentages of patients achieving pain freedom two hours after treatment (defined as a reduction in headache severity from moderate or severe pain to no pain) and whose most bothersome migraine symptom (nausea, light sensitivity or sound sensitivity) stopped two hours after treatment were significantly greater among patients receiving Ubrelvy at all doses compared to those receiving placebo. Patients were allowed to take their usual acute treatment of migraine at least two hours after taking Ubrelvy. 23% of patients were taking a preventive medication for migraine.
Approval Date: 2019-12-01
Company Name: AbbVie