New drug for acute treatment of migraines! Axsome's new oral multi-mechanism drug, AXS-07 Phase III, has significantly better clinical efficacy than Liza tuptan!

September 27, 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 that its new oral multi-mechanism drug, AXS-07, rapidly relieves migraines and significantly reduces recurrence in the Phase III MOMMENTUM trial of acute migraine treatment: compared to the active controlled drug rizatriptan.
the findings were made at the 2020 American Academy of Neurology (AAN) Science Highlights platform.
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 Quptan.
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 lizaquotan is a 5-HT1B/1D astrogen.
AXS-07 is designed to provide rapid, enhanced and persistent migraine relief and reduce recurrence of symptoms.
MOMENTUM is a randomized, double-blind, placebo-controlled and positive drug-controlled Phase III trial based on the FDA Special Program Assessment (SPA) to assess the effectiveness and safety of AXS-07 in acute treatment of moderate to severe migraines.
the study was evaluated using the Migraine Treatment Optimization Questionnaire (mTOQ-4) and only included patients with a history of under-response to previous acute migraine treatments.
study, a total of 1,594 patients were randomly assigned to AXS-07 (20mg MoSEIC meloxicon/10mg lizatuptan), Liza tuptan (10mg), MoSEIC meloxicon (20mg), and placebo therapy in a 2:2:2:1 ratio. The two common main endpoints of the
study were the proportion of patients with AXS-07 who had their headache pain eliminated 2 hours after giving the drug, and the proportion of patients who had their most annoying migraine-related symptoms (nausea, fear of light, or fear of sound) eliminated 2 hours after giving the drug.
is a positive controlled drug in the study and is considered to be the fastest-acting oral quartan and one of the most effective drugs currently available for acute migraine treatment.
previously published results, the study reached two major regulatory endpoints: AXS-07 significantly improved migraine pain and the most annoying symptoms compared to placebos.
addition, the AXS-07 reached a critical secondary endpoint, showing a statistically significant advantage over the active controlled drug rizatriptan in the continued relief of migraine pain.
AXS-07 showed faster and longer-lasting migraine relief than Liza-Trump, according to data released at the AAN conference.
the probability of taking AXS-07 to relieve pain was greater at each point in time within 30 minutes and after the dose than lizatuptan, and the AXS-07 was nearly three times faster to relieve migraine relief (1.5 vs. 4.0 hours, p.lt;0.001).
compared to lizatuptan, AXS-07 significantly reduced migraine recurrence: within 48 hours of taking, 45.2% of patients treated with lizatuptan relapsed, compared with 21.2% of patients treated with AXS-07 (p-0.001).
the time results of migraine relief and recurrence, the advantages of AXS-07 over Lizatuptan are consistent with several other therapeutic measures, including migraine rescue drugs (p.lt;0.001), 24 hours (p-0.006) and 48 hours (p-0.006) 0.003) Continuous pain relief, 24 hours (p-0.038) and 48 hours (p-0.003) sustained pain-free, the overall change of the patient's impression at 2 hours (p-0.022), 24-hour normal function (p-0.027).
Also as mentioned earlier, in the two common main endpoints of the study, a higher proportion of patients in the AXS-07 group achieved pain relief (19.9% vs. 6.7%, p.001) and no most annoying symptoms (36.9% vs. 24.4%, p.002) 2 hours after giving the drug.
the study, the AXS-07 was safe and well-to-do.
most common adverse reactions to AXS-07 were nausea, dizziness, and drowsiness, none of which occurred higher than a placebo or 3%.
based on the findings, Axsome plans to submit an AXS-07 new drug application (NDA) for acute migraine treatment to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2020.
April this year, the AXS-07 Phase III INTERCEPT Study for Early Treatment of Migraines (NCT04163185) was also successful.
need to be noted that the MOMENTUM study included patients with a history of undertreated responses and were treated in the event of a mild or severe migraine attack.
the INTERCEPT study, AXS-07 was given immediately when the earliest symptoms of migraines appeared.
() Original source: Axsome Therapeutics Presents New Data from MOMENTUM Phase 3 Trial with AXS-07 Rapids of Action And Action Reduced Symptoms In The Acute Treatment of Migraine.