Ubrogepant (Ubrelvy) is the first oral anti-CGRP drug to be approved by the FDA for the acute treatment of migraine attacks. It was developed by Allergan, manufacturer of Botox, the safest and arguably the most effective preventive treatment for chronic migraines. Allergan took a risk and bought this drug from Merck after Merck ran into problems developing a similar drug, telcagepant. Fortunately, ubrogepant had none of telcagepant’s problems and it was shown to be safe and effective in two large double-blind placebo-controlled trials.
The FDA-approved package insert says that, UBRELVY is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. The recommended dose is 50 mg or 100 mg taken as needed. If needed, a second dose may be administered at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. It can be taken with or without food. The most common side effects were nausea, seen in 2% of those receiving placebo, 2% of those on 50 mg of ubrogepant and 3% of patients taking 100 mg. The second most common side effect was somnolence, present in 1% of patients taking placebo, 2% of those taking 50 mg and 3% taking 100 mg.
Such a low incidence of side effects is extremely rare with oral drugs, but we also see this with injectable anti-CGRP drugs that are used for the prevention of migraines. The second oral anti-CGRP drug, rimegepant which is awaiting FDA approval, also seems to have very low rates of side effects, which is very reassuring.
The average cost of developing a new drug is $2.6 billion, which means that by necessity new drugs are expensive. This means that insurance companies will require that migraine patients first try and fail generic versions of triptans, such as sumatriptan (Imitrex) or have a contraindication to taking a triptan. Contraindications for the use of triptans include cardiovascular disease (coronary artery disease, strokes, heart attacks, etc.), uncontrolled hypertension, and a few other. Fortunately, ubrogepant can be safely used in such patients.
Oral triptans work well in about 60% of patients, which leaves millions of migraine sufferers without an effective abortive therapy and for these patients, the introduction of ubrogepant could be life-changing.
