Allergan has announced positive results from the first of two Phase 3 trials for ubrogepant, a novel, highly potent, orally-administered calcitonin gene-related peptide receptor antagonist being evaluated for the acute treatment of migraine.
The ACHIEVE I study included 1327 adult patients randomized to receive ubrogepant 50mg (n=423), 100mg (n=448), or placebo (n=456) for the treatment of a single migraine attack of moderate to severe headache intensity. The co-primary endpoints were pain freedom 2 hours after initial dose and absence of most bothersome symptom 2 hours after initial dose.
The results showed that 2 hours after migraine attack, 19.2% and 21.2% of patients in the ubrogepant 50mg and 100mg group were pain free, respectively, compared to 11.8% of corresponding placebo-treated patients. In addition, a greater percentage of ubrogepant patients achieving absence of the most bothersome migraine-associated symptom at 2 hours after the initial dose compared to placebo patients (50mg vs placebo, P=0.0023, 100mg vs placebo, P=0.0023).
Adverse events were similar for ubrogepant and placebo; the most common events were nausea, somnolence, and dry mouth.
“There remains a need for new treatments with improved benefit-risk profiles,” said lead investigator, Dr. Richard B. Lipton, Albert Einstein College of Medicine, NY. “Results from this ubrogepant Phase 3 trial are important in progressing the research and developing therapies to help migraine patients.”
Results from the second trial, ACHIEVE II, are expected at some point in the next few months. The Company expects to file a New Drug Application (NDA) with the FDA in 2019.
For more information visit Allergan.com.