AXS-07 Phase 3 Results for Acute Migraine (Momentum)

Axsome Therapeutics released phase 3 clinical data with AXS-07 for the treatment of acute migraine, for patients with an inadequate response to prior treatments.
The clinical trial met the two co-primary endpoints; Pain-Free at 2 hours after dose, and Absent most Bothersome Symptoms 2 hours after dose versus placebo. The clinical trial can be found here Momentum Phase 3. The trial also compared AXS-07 to Rizatriptan (a well known and effective generic drug for acute migraine) for these tough to treat patients, who have not responded to prior treatments. Comparisons below are AXS-07 versus Rizatriptan.

• Sustained pain freedom from 2 to 24 hours after dosing.  16.1% vs 11.2%  p=0.038
• Sustained pain relief from 2 to 24 hours after dosing.  53.3% vs 43.9%  p=0.006
• Sustained pain relief from 2 to 48 hours after dosing.  46.5% vs 36.5%  p=0.003
• Rescue medication was used for 23.0% of AXS-07 patients vs 34.7%  p=0.001
• Patient Global Impression of Change, AXS-07 vs Rizatriptan.                             p=0.022
• Return to normal function at 24 hours.                                                                      p=0.027

The clinical trial was a success, as AXS-07 above, compared well to the generic acute migraine drug Rizatriptan. The safety profile of AXS-o7 was similar to placebo. The company plans to file an NDA (new drug application) in the second half of 2020.

AXS-07 for Acute Migraine

Axsome’s AXS-07 is designed to treat acute episodes of migraine. The drug is a combination of Meloxicam and Rizatriptan. Rizatriptan belongs in a group called triptans which are oral drugs designed to treat moderate to severe migraine headaches. AXS-07 will also compete against a newer group of oral drugs known as CGPR inhibitors similar to Allergan's Ubrogepant. The recently announced news from Axsome, was that the company met with the FDA in May, and was told that the current phase 3 clinical trial for acute migraine AXS-07 Phase 3, if successful, would be the only clinical trial needed to file a new drug application (NDA).  The clinical trial is currently being run under a Special Protocol Assessment (SPA) which was granted by the FDA prior to the trial beginning. Axsome also announced that a 12-month safety study has commenced. Patients will roll off the current phase 3 clinical trial, and into the 12 month safety study, which is a standard requirement for a new drug application to be filed with the FDA. The company is expected to file for FDA approval in the second half of 2020, which could lead to approval in 2021. The patent for AXS-07 runs into 2036.  Thank you for reading.