The oral, dual-mechanism therapy from Axsome Therapeutics met both of its primary end points in the phase 3 MOMENTUM trial in acute migraine, and is expected to be filed with the FDA.
Richard B. Lipton, MD, professor, vice chair of neurology, and director, Montefiore Headache Center, Albert Einstein College of Medicine
Richard B. Lipton, MD
Axsome Therapeutics has announced that its investigational acute migraine treatment, AXS-07, met both of its primary end points in a phase 3 trial, in addition to meeting the key secondary end point of superiority to an active comparator.
The oral and dual-mechanism therapy—which consists of the novel MoSEIC™ meloxicam, a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID), and rizatriptan, a 5-HT1B/1D agonist—was shown to improve both migraine pain (P <.001) and the most bothersome symptoms (P = .002) compared to placebo. Axsome stated that these results, along with the demonstration of component contribution, support the filing of an NDA for AXS-07 in the acute treatment of migraine.
“In the MOMENTUM trial, AXS-07 provided greater and more lasting migraine pain relief than rizatriptan,” Richard B. Lipton, MD, professor, vice chair of neurology, and director, Montefiore Headache Center, Albert Einstein College of Medicine, said in a statement. “Given that rizatriptan is one of the most effective triptans and that the study enrolled patients with difficult-to-treat migraine, this finding is impressive.”
The trial included 1594 patients randomized in a 2:2:2:1 ratio to AXS-07 (20 mg MoSEIC™ meloxicam/10 mg rizatriptan), rizatriptan (10 mg), MoSEIC™ meloxicam (20 mg), or placebo, to treat a single migraine attack of moderate or severe intensity. AXS-07 met the 2 co-primary end points with high statistical significance, first showing a greater percentage of patients achieving pain freedom (19.9%) compared to placebo (6.7%). Second, the absence of the most bothersome symptom (36.9%) compared to placebo (24.4%) was significant. Both were assessed 2 hours after dosing.
As for its secondary end point, compared to rizatriptan, MoSEIC™ meloxicam, and placebo, AXS-07 showed significant numbers of patients achieving pain-freedom (16.1%, 11.2%, 8.8%, and 5.3%, respectively; P = .038, P = .001, and P <.001, respectively versus AXS-07).
“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,” Lipton said. “The results of this study suggest that AXS-07 may provide an important treatment option for people with difficult-to-treat migraine.”
All told, at every time point measured, the Axsome agent displayed a higher percentage of patients achieving relief from pain, starting from 15 minutes. This difference became statistically significant at 60 minutes (P = .04). At 90 minutes post-dose, 60.5% of those treated with AXS-07 had pain relief compared to 52.5% for rizatriptan (P = .019) and placebo (P = .004). Additionally, AXS-07 was statistically significantly superior to rizatriptan on several other secondary end points, such as the Patient Global Impression of Change (PGI-C; P = .022), and return to normal functioning at 24 hours (P = .027).
“The results of MOMENTUM demonstrate the ability of AXS-07 to provide unique benefits to migraine patients, with fast, strong, and durable relief of migraine pain as compared to a potent active comparator in a stringently designed trial enriched with patients with difficult-to-treat migraine,” said Herriot Tabuteau, MD, chief executive officer, Axsome, in a statement. “These data have potentially important implications for patient care based on the high rate of inadequate response to and patient dissatisfaction with current treatments.”
The company noted that further study results, including additional secondary end points, will be submitted for presentation at upcoming medical meetings and for publication. Additionally, the treatment is being assessed in the INTERCEPT phase 3 trial, evaluating the early treatment of migraine with AXS-07. These patients are expected to administer AXS-07 at the earliest sign of migraine pain.
Axsome Therapeutics Announces AXS-07 Achieves Co-Primary and Key Secondary Endpoints in MOMENTUM Phase 3 Migraine Trial in Patients with History of Inadequate Response [press release]. New York, NY: Axsome Therapeutics; Published December 30, 2019. biospace.com/article/releases/axsome-therapeutics-announces-axs-07-achieves-co-primary-and-key-secondary-endpoints-in-momentum-phase-3-migraine-trial-in-patients-with-history-of-inadequate-response. Accessed January 2, 2020.