Axsome Therapeutics Presents Positive AXS-07 Phase 1 Trial Results at the 19th Congress of the International Headache Society
Dual mechanisms, rapid absorption and long half-life support therapeutic potential of AXS-07 in migraine
AXS-07 MOMENTUM Phase 3 trial ongoing in migraine patients with history of inadequate response to prior acute treatments
The Phase 1 trial examined the pharmacokinetics of AXS-07 tablets (20 mg MoSEIC meloxicam/10 mg rizatriptan), and 10 mg standard rizatriptan in healthy volunteers. After oral administration of AXS-07, therapeutic plasma concentrations of MoSEIC meloxicam were attained in a median time of 17 minutes, the trial’s pre-specified primary endpoint, while maximum plasma concentrations of the rizatriptan component were reached in a median time of 38 minutes. These results suggest the potential for enhanced onset of action for AXS-07. In addition, the terminal half-life of MoSEIC meloxicam was 18 hours indicating the potential for sustained effect. With the administration of AXS-07, the absorption of rizatriptan was numerically faster, and the resulting plasma concentrations numerically greater, as compared to standard rizatriptan. AXS-07 was well tolerated with no relevant differences in safety profile across the two treatment arms. There were no serious adverse events in the study.
The efficacy of AXS-07 in the acute treatment of migraine is currently being evaluated in the ongoing MOMENTUM Phase 3 trial, in which patients are randomized to treatment with AXS-07, rizatriptan, MoSEIC meloxicam, or placebo. MOMENTUM is enrolling only patients with a history of inadequate response to prior acute treatments, assessed using the Migraine Treatment Optimization Questionnaire (mTOQ-4), and the majority of patients randomized to date also report associated allodynia (pain from a normally non-painful stimulus), reflecting a more treatment-resistant population.
The presentation at the IHC includes the Phase 1 trial results as well as information on the design and targeted patient population of the ongoing MOMENTUM Phase 3 trial. Below are the details of the poster presentation:
Title: AXS-07 (MoSEIC™ Meloxicam/Rizatriptan): Novel Oral Therapeutic in Clinical Development for the Acute Treatment of Migraine
Poster Number: IHC-PO-124
Date and Time:
A copy of the poster presentation is available on the “Publications” page of the “Science” section of Axsome’s website at www.axsome.com.
Phase 1 Trial Design
The study was a randomized, parallel group trial to evaluate the pharmacokinetics and safety of AXS-07 tablets (20 mg MoSEIC™ meloxicam/10 mg rizatriptan), and 10 mg standard rizatriptan, after single-dose, oral administration in healthy volunteers. A total of 20 healthy volunteers were randomly assigned in a 1:1 ratio to treatment with AXS-07 or standard rizatriptan, under fasting conditions. The primary endpoint was the time to therapeutic concentration of meloxicam.
AXS-07 is a novel, oral, investigational medicine with distinct dual mechanisms of action under development for the acute treatment of migraine. AXS-07 consists of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (
Forward Looking Statements
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Source: Axsome Therapeutics, Inc.