New drug for acute treatment of migraines! Axsome's new oral multi-mechanism drug AXS-07 Phase III Clinical: Fast and effective long-lasting migraine relief!

December 31, 2020 // -- Axsome Therapeutics is a biopharmaceutical company dedicated to the development of innovative therapies for the treatment of central nervous system (CNS) diseases.
, the company announced positive results for evaluating its new oral multi-mechanism drug AXS-07 for the long-term open-label Phase 3 MOVEMENT test for acute migraine treatment.
in this trial, AXS-07 treatment can quickly, effectively and lastingly relieve migraines and related symptoms.
AXS-07 is well-resistant in long-term treatment and its safety is consistent with previously reported controlled trials.
Axsome is still expected to submit a new AXS-07 drug application (NDA) for acute migraine treatment in the first quarter of 2021.
AXS-07 is a new oral drug with a unique dual mechanism of action and is currently being clinically developed for acute treatment of migraines.
AXS-07 consists of MoSEIC Meloxicam and Liza tuptan.
Meloxicon is a new molecular entity that uses Axisome's MoSEIC (Molecular Solubility Enhancement Package) technology to treat migraines, which allows meloxicon to absorb quickly while maintaining a long plasma half-life.
meloxicon is a COX-2 biased nonsteroidal anti-inflammatory drug, and liza tuptan is a 5-HT1B/1D astrogen.
AXS-07 is designed to provide rapid, enhanced and persistent migraine relief and reduce recurrence of symptoms.
, chief executive of
Axsome, said: "The results of the Open Label Phase 3 MOVEMENT trial confirm the strong efficacy of AXS-07 observed in our previous controlled trials and demonstrate good long-term safety.
the rapid and substantial efficacy of AXS-07, which has been observed in three separate trials, suggests that AXS-07 may provide unique benefits for migraine sufferers and help address currently unsolved needs for more effective treatment.
data further supports our plan to submit an application in the first quarter to use AXS-07 for acute treatment of migraines.
" MOVEMENT is an open label Phase 3 trial designed to assess the long-term safety of AXS-07 in patients with migraine attacks for up to 12 months.
patients in the study group completed the AXS-07 key clinical studies MOMENTUM and INTERCEPT.
over a 12-month period, these patients were allowed to treat up to 10 migraine episodes per month, taking AXS-07 once per migraine episode.
safety and effectiveness of the AXS-07 was evaluated during the test.
706 patients were included in the trial.
the trial ended when at least 300 patients had migraines at least twice a month for six months and about 100 patients treated for migraines at least twice a month for 12 months.
at the end of the trial, 515 patients were treated for at least six months and 155 patients for at least 12 months.
trial, more than 21,000 migraine episodes were treated with AXS-07.
: Oral AXS-07 can quickly and substantially relieve migraines and related symptoms.
1 hour after the drug was given, 39% of patients (range: 37-41%) had migraine relief, indicating that AXS-07 was effective quickly.
two hours after taking AXS-07, 68% (range: 65-71%) had migraine reduction and 38% (range: 37-40%) had reduced pain.
addition, 47% (range: 46-49%) of patients were free of the most annoying symptoms (fear of light, fear of sound, nausea) within 2 hours of being given the drug.
AXS-07 provides lasting relief from migraines, with 85% (range: 84-86%) patients not using rescue drugs within 24 hours and 83% (range: 82-85%) not using rescue drugs within 48 hours of taking AXS-07 alone.
2-24 hours and 2-48 hours were 60% (range: 59-62%) and 59% (58-60%), respectively.
33% (range: 33-35%) and 32% (range: 32-34%) for 2-24 hours and 2-48 hours, respectively.
AXS-07 has good long-term dosing tolerance.
safety of AXS-07 during the 12-month treatment period was consistent with previously reported in short-term controlled trials.
most common adverse reactions (≥3%) were nausea, dizziness and vomiting.
1.6 percent of patients stopped taking the drug because of adverse events in a 12-month trial.
() Origin: Axsome Therapeutics Announces Positive Efficacy and Safety Results from the Phase 3 MOVEMENT Long-Term Trial of AXS-07 in The Acute Treatment of Migraine