- Allergan (NYSE:AGN) is up 2% premarket on light volume in response to its announcement of positive results from a Phase 3 clinical trial, ACHIEVE I, evaluating ubrogepant in adult patients experiencing a single migraine attack. Both co-primary endpoints were met.
- 19.2% (n=81/423) of those receiving 50 mg and 21.2% (n=95/448) of those receiving 100 mg achieved pain freedom at two hours versus 11.8% (n=54/456) for placebo (p=0.0023 and p=0.0003, respectively).
- 38.6% (n=163/423) of the 50 mg cohort and 37.7% (n=169/448) of the 100 mg cohort achieved absence of the most bothersome migraine-associated symptom at hour two compared to 27.8% (n=127/456) for placebo. (p=0.0023 and p=0.0023, respectively).
- On the safety front, ubrogepant was well-tolerated with a profile similar to placebo. The most common adverse events were nausea, drowsiness and dry mouth (all less than 5%). There were six cases of elevated liver enzymes greater than three times the upper limit of normal across both treatment arms and placebo. All were determined to be related to other medications or illness.
- Additional data will be submitted for presentation at future medical conferences.
- Results from a second Phase 3, ACHIEVE II, should be available next quarter.
- The company expects to file its U.S. marketing application in 2019.
- Ubrogepant is an orally available calcitonin gene-related peptide (CGRP) receptor antagonist. CGRP and its receptors are expressed in regions on the nervous system associated with migraine pathophysiology.
- MIgraine rival Teva Pharmaceutical Industries (NYSE:TEVA) is down 2% premarket.
- Now read: Allergan - I Am Allergic To Aggressive Practices
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