Allergan migraine drug shown to be safe, effective in late-stage trial

UPI Finance 3 weeks ago

Nov. 19 (UPI) -- Migraine sufferers might soon have a new weapon against the condition's painful symptoms.

In a Phase 3 clinical trial, results of which were published Tuesday in the Journal of the American Medical Association, ubrogepant, manufactured by Allergan, was found to reduce pain and address the "most bothersome" symptoms experienced by those who have migraine headaches.

In addition to pain, migraine sufferers often report symptoms such as nausea and sensitivity to light and sound.

"Ubrogepant has a novel mechanism of action and a favorable safety and tolerability profile," study co-author Dr. Richard B. Lipton, director of the headache center at Montefiore Medical Center in New York City, told UPI.

Lipton said the drug is part of a "new class of migraine-specific acute treatments known as "gepants" that target calcitonin gene-related peptide, a key molecule involved in the development of migraine pain and related symptoms.

"Gepants can be taken orally at the time of an attack to relieve pain and other migraine symptoms and restore function," Lipton said, adding that ubrogepant could be an option for patients who "cannot safely take triptans," a commonly used class of drugs for the severe headaches, because they have cardiovascular disease.

Triptans have been shown to "constrict blood vessels," which can cause heart attack and stroke, he said.

Allergan received approval of its new drug application for ubrogepant from the Food and Drug Administration in March. The company has said it expects full FDA approval for the migraine treatment in December. Phase 3 clinical trials that show safety and efficacy of a new drug generally are the final step in the approval process before the FDA acts.

Lipton and his colleagues tested ubrogepant, which is taken orally in capsule form, at two dosing levels -- 50 and milligrams. In all, roughly 22 percent of the study participants who received the 50 mg. strength and 21 percent of those who received the 25 mg. dose reported "pain freedom" two hours after taking the medication, compared to just 14 percent among those who received a placebo.

Notably, "absence of the most bothersome" symptom -- pain, nausea or sensitivity to light and/or sound -- was reported by nearly 40 percent of participants who took the 50 mg. dose and 34 percent of those who took the 25. mg. dose within two hours of taking the drug.

The most common side effects reported by those taking ubrogepant were nausea and dizziness.

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