Migraine medicine! Axsome's new oral multi mechanism drug axs-07 has been successfully used in the phase III clinical treatment of migraine!

December 31, 2019 / BIOON / -- axsome therapeutics is a clinical stage biopharmaceutical company dedicated to the development of innovative therapies for the treatment of central nervous system (CNS) diseases Recently, the company announced that the phase III momentum trial to evaluate the new oral multi mechanism drug axs-07 for acute migraine treatment reached two regulatory common primary endpoints: axs-07 significantly improved migraine pain and most annoying symptoms compared with placebo In addition, axs-07 also reached a key secondary end point, showing a statistically significant advantage over the active control drug rizatriptan in the continuous relief of migraine pain According to the results of the study, axsome plans to submit axs-07 new drug application (NDA) for acute migraine treatment to the U.S Food and Drug Administration (FDA) in the second half of 2020 Axs-07 is a new oral drug with unique dual action mechanism, which is currently being developed clinically for the acute treatment of migraine Axs-07 is composed of moseic meloxicam and rizatriptan Meloxicam is a new molecular entity for the treatment of migraine using axsome moseic (molecular solubility enhancing inclusion complex) technology, which can make meloxicam rapidly absorbed and maintain a long plasma half-life Meloxicam is a COX-2 biased non steroidal anti-inflammatory drug Rizatriptan is a 5-HT1B / 1D agonist Axs-07 is designed to provide rapid, enhanced and sustained migraine relief and reduce symptom recurrence Momentum is a randomized, double-blind, placebo-controlled, and positive drug-controlled phase III trial conducted in accordance with the FDA special program evaluation (SPA) to evaluate the efficacy and safety of axs-07 in the treatment of moderate to severe migraine The study was evaluated with the migraine treatment optimization questionnaire [mtoq-4], and only patients with a history of inadequate response to previous acute migraine treatment were enrolled In the study, 1594 patients were randomly assigned to receive axs-07 (20mg moseic meloxicam / 10mg rizatriptan), rizatriptan (10mg), moseic meloxicam (20mg), placebo The two common primary endpoints of the study were the proportion of patients with headache pain relief at 2 hours after administration of axs-07, and the proportion of patients with the most annoying migraine related symptoms (nausea, photophobia or voice fear) relief at 2 hours after administration Rizatriptan is a positive control drug in this study, which is considered to be one of the most effective drugs in the treatment of migraine The results showed that the study reached two common primary endpoints, and the data were highly statistically significant: two hours after administration, a higher proportion of patients in the axs-07 treatment group achieved pain relief (19.9% vs 6.7%, P < 0.001) and no most annoying symptoms (36.9% vs 24.4%, P = 0.002) compared with the placebo group In addition, axs-07 also achieved the advantages specified in spa compared with rizatriptan, moseic meloxicam and placebo: a higher proportion of patients achieved continuous pain relief (16.1%, 11.2%, 8.8%, 5.3%; P = 0.038, P = 0.001, P < 0.001) 2-24 hours after administration The positive results of the common primary endpoint and component contribution certificate support the regulatory submission of axs-07 for new drug application for acute migraine treatment (NDA) In addition, axs-07 provides greater and longer-lasting migraine relief compared to placebo and rizatriptan, with a significant reduction in the use of migraine rescue drugs The proportion of patients with continuous pain relief 2-24 hours after administration was 53.3% in axs-07 group, 33.5% in placebo group and 43.9% in rizatriptan group (P < 0.001, P = 0.006, respectively) The proportion of patients with persistent pain relief within 2-48 hours was also significantly higher, 46.5% in the axs-07 group, 31.1% in the placebo group and 36.5% in the rizatriptan group (P < 0.001, P = 0.003, respectively) The proportion of patients who used rescue drugs was 23.0% in axs-07 group, 43.5% in placebo group and 34.7% in rizatriptan group (all P < 0.001 compared with axs-07) Axs-07 can relieve migraine rapidly At each time point measured from 15 minutes, the proportion of patients whose axs-07 can relieve migraine is statistically higher than that of rizatriptan group, and statistically significantly higher than that of rizatriptan group at 60 minutes (P = 0.04) The proportion of patients with pain relief 1.5 hours after administration was 60.5% for axs-07, 52.5% for rizatriptan and 48.3% for placebo (P = 0.019 and P = 0.004, respectively) Axs-07 was significantly superior to rizatriptan in several other secondary endpoints (including the patient's overall impression of change [pgi-c], P = 0.022) and 24-hour recovery of normal function (P = 0.027) In this study, axs-07 was safe and well tolerated The most common adverse reactions of axs-07 are nausea, dizziness and drowsiness The incidence of these adverse reactions is no higher than that of placebo or 3% A serious adverse event occurred in the axs-07 treatment group, which was considered by the investigator to be unrelated to the study drug Currently, axs-07 is also evaluated in the phase III intercept trial, a randomized, double-blind, placebo-controlled study evaluating the early treatment of migraine with axs-07 In the momentum study, patients with a history of insufficient response to treatment were enrolled, and they were given treatment once they had a moderate or severe migraine attack; in the intercept study, axs-07 was given when the earliest symptoms of migraine occurred Original source: axsome therapeutics announcements axs-07 achievements co primary and key secondary endpoints in momentum phase 3 migrate trial in patients with history of intake response