Axsome Therapeutics has announced that its novel medicine AXS-07 hit its endpoints in a Phase III migraine trial.
The oral, multi-mechanistic investigational drug met the two regulatory co-primary endpoints and significantly improved migraine pain and most bothersome symptoms, compared to placebo.
The MOMENTUM Phase III trial also met the key secondary endpoint, demonstrating statistically significant superiority to its active comparator rizatriptan on sustained freedom from migraine pain.
In the trial, 19.9% of patients compared to 6.7% achieved pain freedom, as well as 36.9% versus 24.4% becoming absent of the most bothersome symptom two hours after dosing.
The positive outcome supports the filing of a New Drug Application (NDA) for AXS-07 in the acute treatment of migraine.
Given that rizatriptan – the treatment’s comparator - is one of the most effective triptans, so as the “study enrolled patients with difficult-to-treat migraine, this finding is impressive,” said Richard Lipton, professor and vice chair of Neurology, and director of the Montefiore Headache Center, at the Albert Einstein College of Medicine.
He continued, “Many patients experience a suboptimal response to their current acute migraine treatments, placing them at increased risk of headache related disability and progression to chronic migraine, factors associated with increased healthcare costs. The results of this study suggest that AXS-07 may provide an important treatment option for people with difficult-to-treat migraine.”
In addition to the efficacy, AXS-07 was safe and well tolerated in the trial. The most commonly reported adverse events reported were nausea, dizziness and somnolence, none of which occurred at a rate greater than placebo or greater than 3%.
Last month shares in Axsome increased more than 80% after a Phase III study of the experimental drug AXS-05 in adults with moderate-to-severe major depressive disorder met its primary endpoint.