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Ubrogepant outperforms triptans as migraine treatment

PHILADELPHIA — The oral calcitonin gene-related peptide antagonist ubrogepant provided better pain relief than triptans in patients with migraine, according to study results presented at the American Headache Society Annual Scientific Meeting.

Susan Hutchinson, MD, of the Orange County Migraine & Headache Center, explained the need for new migraine therapies.

“Triptans have their limitations. They have suboptimal efficacy, side effects and contradictions,” she said.

Researchers reviewed data from 3,358 patients with migraine (with and without aura) randomized in an approximate 1:1:1:1 ratio to receive either a 25-mg dose, 50-mg dose or 100-mg dose of ubrogepant (Allergan) or placebo. Patients were labeled as triptan-effective, triptan-ineffective or triptan-naive based on previous treatment attempts.

 

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Hutchinson and colleagues found that across all subgroups, those who received ubrogepant had higher response rates for 2-hour pain freedom and most bothersome pain symptom.

Other ubrogepant data presented at the meeting included:

• An onset of pain relief was achieved at 1 hour in 43% of the 887 patients who received 50 mg of ubrogepant and 37% of the 912 patients who received placebo; absence of most bothersome migraine symptom occurred at 1.5 hours in 28% of the 50-mg ubrogepant recipients and 22% of the placebo recipients; and pain freedom happened at 2 hours in 20% of the 50-mg ubrogepant recipients and 13% of the placebo recipients.
• A “significantly higher” proportion of the 1,144 patients who opted to take a second 25-mg or 50-mg dose of ubrogepant experienced pain freedom at 2 hours after the additional dose.
• There was “no evidence” of more adverse events tied to cardiovascular risk in 3,358 patients with migraine (with and without aura) randomized in an approximate 1:1:1:1 ratio to receive either a 25-mg dose, 50-mg dose or 100-mg dose of ubrogepant or placebo.
• The 813 patients who received either intermittent 50-mg or 100-mg doses of ubrogepant for the acute treatment of migraine attacks over 1 year reported the drug was well tolerated and identified no safety concerns.
• The 256 patients who received 100 mg of ubrogepant as part of an intermittent, high-frequency dosing regimen reported the drug was well tolerated and produced no safety concerns. Researchers added that the patients in this study had a mean age of 32 years, an average BMI of 25, 55% were women, 68% were white and 25% were black, “which differs from the typical migraine population.”

Ubrogepant’s PDUFA data is scheduled for the fourth quarter of 2019, according to an Allergan press release. – by Janel Miller

References:

Ailani J, et al. An optional second dose of ubrogepant is effective in achieving 2-hour pain freedom in the acute treatment of migraine.

Ailani J, et al. Long-term safety evaluation of ubrogepant for the acute treatment of migraine attacks.

Blumenfeld A, et al. Ubrogepant is effective for the acute treatment of migraine in patients for whom triptans are ineffective.

Dodick D, et al. Ubrogepant achieves onset of pain relief at 1 hour for the acute treatment of migraine.

Goadsby P, et al, Safety and tolerability of ubrogepant following intermittent, high-frequency dosing.

Hutchinson S, et al. Safety of ubrogepant in participants with moderate to high cardiovascular risk.

All presented at: American Headache Society Annual Scientific Meeting; July 11-14, 2019; Philadelphia.

Disclosures: Hutchinson reports serving as an advisor and speaker for Allergan.