Axsome Therapeutics reported positive data from the long-term, open-label Phase III MOVEMENT trial of AXS-07 for the treatment of acute migraine.
Axsome Therapeutics reported positive data from the long-term, open-label Phase III MOVEMENT trial of AXS-07 for the treatment of acute migraine.
The drug is a novel, oral, rapidly-absorbed drug with several methods of action. A new molecular entity, it utilizes the company’s Molecular Solubility Enhanced Inclusion Complex (MoSEIC) technology, which allows rapid absorption of meloxicam while maintaining a longer half-life in the blood. The drug is a combination of meloxicam and rizaptriptan. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory and rizaptriptan is a 5-HT1B/1D agonist.
The company expects to submit a New Drug Application (NDA) in the first quarter of 2021.
The MOVEMENT trial evaluated long-term safety of the drug for up to 12 months in patients with migraine attacks. It enrolled patients who had finished the previous pivotal trials, MOMENTUM and INTERCEPT. Patients in the trial were allowed to treat up to 10 migraine attacks per month up to a 12-month period, with a single dose of AXS-07 for each migraine.
A total of 706 patients were enrolled and it was finished when at least 300 patients had treated at least two migraines a month for six months, and about 100 patients had treated at least two migraines a month for 12 months. At the end of the study, 515 patients had reached at least six months, and 155 had reached at least 12 months. Over 21,000 migraine attacks were treated with the drug during the course of the trial.
“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,” said Herriot Tabuteau, chief executive officer of Axsome.
He went on to say, “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. These data further support our planned NDA filing of AXS-07 in the acute treatment of migraine in the first quarter.”
In the MOVEMENT trial, dosing of AXS-07 caused rapid and “substantial relief” of migraine pain and the symptoms associated with it. These are often pulsating, severe and disabling head pain, nausea, sensitivity to light and to sound.
Within one hour after receiving AXS-07, 39% of participants achieved migraine pain relief. Two hours after receiving AXS-07, migraine pain relief was achieved by 68% of patients and pain freedom by 38%. Freedom from light and sound sensitivity and nausea was achieved by 47% of patients within two hours of receiving the drug.
The drug relieved migraine pain for 85% of patients in a durability evaluation, keeping them free from rescue medication use through 24 hours, and 83% free from rescue medication through 48 hours after a single administration. The study reported rates of sustained pain relief from two to 24 hours of 60% and two to 48 hours of 59%. Rates of sustained freedom from pain for two to 24 hours was 33% and from two to 48 hours was 32%.
The drug was well tolerated over long-term dosing with a 12-month safety profile consistent with those observed in the short-term trials. The most common adverse events were nausea, dizziness, and vomiting. During the year, only 1.6% of patients dropped out of the trial because of adverse events.
