Axsome Therapeutics, a US-based biopharmaceutical company, has reported positive data from the phase 3 trial of “AXS-07” for the treatment of acute migraine.
The drug is a combination of meloxicam and rizatriptan, which has several methods of action.
Sold under the brand name Mobic, meloxicam is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. Rizatriptan, which is available under the brand name Maxalt, is a medication used for the treatment of migraine headaches.
Axsome expects to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the first quarter of 2021.
The clinical trial evaluated long-term safety of AXS-07 for up to 12 months in patients with migraine attacks. The patients were allowed to treat up to 10 migraine attacks a month for up to 12 months, with a single dose of AXS-07 for each migraine attack.
Axsome CEO Herriot Tabuteau said, “The results of the open-label, Phase III MOVEMENT trial confirm in a real-world setting the strong efficacy of AXS-07 observed in our previous controlled trials, and demonstrate a favorable long-term safety profile.”
“The rapid and substantial efficacy of AXS-07 now observed in three separate trials indicates that ASX-07 may provide unique benefits to patients with migraine and help address the current unmet need for more effective treatments,” he added. “These data further support our planned NDA filing of AXS-07 in the acute treatment of migraine in the first quarter.”
The trial found that a dose of AXS-07 caused rapid and “substantial relief” of migraine pain and the symptoms associated with it, such as pulsating, severe and disabling headaches, nausea, sensitivity to light or sound.
Nearly 40% of the patients who received AXS-07 achieved migraine pain relief within an hour. Within two hours of receiving AXS-07, 68% of the patients achieved migraine pain relief.
In addition, 47% of the patients achieved relief from nausea and light/sound sensitivity within two hours of receiving the drug.
Overall, AXS-07 relieved migraine pain for 85% of the patients, keeping them free from rescue medication use through 24 hours.
The combination of meloxicam and rizatriptan was well tolerated over long-term dosing with a 12-month safety profile.
Some of the most common side effects reported during the trial were nausea, dizziness, and vomiting. The article originally appeared on BioSpace.
