New medicine for acute migraine treatment! Axsome's new oral multi mechanism drug axs-07 is used in the early stage of migraine treatment and is in phase III clinical!

February 23, 2020 / 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 evaluation of the new oral multi mechanism drug axs-07 (moseic melody CAM / rizatriptan) for the early treatment of migraine in the phase III intercept study (nct04163185) has completed the enrollment of patients Axs-07 is a new oral drug with unique dual action mechanism, which is currently being developed for the acute treatment of migraine Axsome expects to get the top line results of the intercept study in the first quarter of 2020 This is a randomized, double-blind, single dose, placebo-controlled phase III study to evaluate the efficacy and safety of axs-07 and placebo in the early treatment of migraine In this study, approximately 300 adult patients will be randomly assigned 1:1 to receive axs-07 or placebo as soon as the earliest symptoms of migraine appear The two common primary endpoints of the study were the proportion of patients who had no headache (headache elimination) at 2 hours after administration, and the proportion of patients who did not have the most annoying migraine related symptoms (nausea, photophobia, voice fear) at 2 hours after administration Axs-07 is a new oral drug with unique dual action mechanism It 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 By the end of December 2019, the phase III momentum trial to evaluate axs-07 for acute migraine treatment reached two regulatory common primary endpoints: axs-07 significantly improved migraine pain and most annoying symptoms compared to 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 It should be noted that in the momentum study, patients with a history of inadequate response to treatment were enrolled and were treated in the event of a moderate or severe migraine attack In contrast to the intercept study, axs-07 was administered immediately when the earliest symptoms of migraine occurred 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 (BIOON Com) original source: axsome therapeutics complete patient enrollment in the intersect phase 3 trial of axs-07 in the early treatment of migration