Benzinga | Aug 20, 2020 07:02AM EDT

Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting For AXS-07 For Acute Treatment Of Migraine

NDA submission on track for 4Q 2020

NEW YORK, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it has completed a successful pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for AXS-07 for the acute treatment of migraine. AXS-07 is Axsome's novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine. The purpose of the meeting was to reach agreement with the FDA on the proposed content and format of the Company's planned NDA submission including the clinical and nonclinical requirements.

Based on the feedback from the FDA, the Company believes its regulatory data package will be sufficient to support an NDA for AXS-07 for the acute treatment of migraine, and Axsome remains on track to submit the planned NDA in the fourth quarter of 2020. Acceptance of the final NDA will be subject to the FDA's review of the complete filing.

"Axsome is pleased with the outcome of our recent pre-NDA meeting with the FDA, which confirmed the studies and data to be presented in our planned NDA submission of AXS-07 for the acute treatment of migraine," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. "AXS-07 incorporates multiple mechanisms of action, and rapid absorption after oral administration, to address various migraine processes with the goal of providing enhanced effectiveness. We remain on track to complete the submission in the fourth quarter to make this new potential therapy available to patients living with migraine."

Axsome previously announced positive results from two Phase 3, randomized, controlled trials of AXS-07 in the acute treatment of migraine, the MOMENTUM and INTERCEPT trials, which demonstrated rapid, substantial, and statistically significant elimination of migraine pain and prevention of progression of migraine pain intensity with AXS-07 compared to control.

MOMENTUM, conducted pursuant to an FDA Special Protocol Assessment, randomized 1,594 patients with a history of inadequate response to prior acute migraine treatments to treat a single migraine attack with AXS-07, rizatriptan, MoSEIC(tm) meloxicam, or placebo. Rizatriptan, an active comparator in the trial, is considered to be the fastest acting oral triptan and one of the most effective medications currently available for the acute treatment of migraine [1]. AXS-07 provided substantially greater and more sustained migraine pain relief compared to placebo and rizatriptan, which translated to a significant reduction in rescue medication use for AXS-07 compared to placebo and rizatriptan. The percentage of patients achieving sustained pain relief from 2 to 24 hours after dosing was 53.3% for AXS-07, compared to 33.5% for placebo and 43.9% for rizatriptan (p<0.001, p=0.006, respectively versus AXS-07). Rescue medication was used by 23.0% of AXS-07 patients, compared to 43.5% of placebo and 34.7% of rizatriptan patients (p<0.001 for each group versus AXS-07). AXS-07 provided rapid relief of migraine pain with the percentage of patients achieving pain relief with AXS-07 being numerically greater than with rizatriptan at every time point measured starting at 15 minutes.

INTERCEPT randomized 302 patients to treat a single migraine attack with AXS-07 or placebo, at the earliest sign of migraine pain, while the pain intensity was mild. In this trial, AXS-07 resulted in a statistically significantly greater percentage of patients as compared to placebo achieving pain freedom (32.6% versus 16.3%, p=0.002) and freedom from most bothersome symptom (43.9% versus 26.7%, p=0.003), 2 hours after dosing (co-primary endpoints). A single dose of AXS-07 prevented progression of migraine pain beyond mild intensity in 73.5% of patients versus 47.4% of placebo patients (p<0.001), with rescue medication being required by only 15.3% of AXS-07 patients versus 42.5% of placebo patients (p<0.001) within 24 hours after dosing. AXS-07 rapidly eliminated migraine symptoms, with numerical separation from placebo as early as 30 minutes for migraine pain freedom and most bothersome symptom freedom.

AXS-07 was safe and well tolerated in both trials. The most commonly reported adverse events with AXS-07 in the MOMENTUM trial were nausea, dizziness and somnolence, none of which occurred at a rate greater than placebo or greater than 3%. The most commonly reported adverse events with AXS-07 in the INTERCEPT trial were somnolence, dizziness, and paresthesia, all of which occurred at a rate of less than five percent.