A Synergistic Therapeutic Approach
How It Works
The components of AXS-07, MoSEIC™ meloxicam and rizatriptan, are combined for a potentially synergistic effect with enhanced efficacy over currently available therapies in the treatment of migraine. Meloxicam is an NSAID that provides potent pain relief with a long duration of action. However, standard meloxicam has an extended time to maximum plasma concentration (Tmax). AXS-07 utilizes Axsome’s proprietary MoSEIC™ technology to achieve rapid peak plasma levels of meloxicam after oral administration without compromising its long half-life. Rizatriptan is currently approved as a single agent for the acute treatment of migraine and targets different migraine-inducing CNS receptor systems than meloxicam
Clinical and Regulatory
AXS-07 is currently being developed for the acute treatment of Migraine. We intend to seek FDA approval for AXS-07 utilizing the 505(b)(2) regulatory development pathway. An NDA is planned.
The Centers for Disease Control estimate that over 37 million Americans suffer from migraines. According to the American Migraine Foundation, it is a greater source of disability in the United States than any other neurological disorder. Migraine is characterized by recurrent attacks of pulsating, often severe and disabling head pain associated with nausea, and sensitivity to light and or sound.