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- meloxicam/rizatriptan (AXS-07) / Axsome Therap
Combined efficacy and safety of AXS-07 (MOSEIC(TM) meloxicam and rizatriptan) in two phase 3 clinical trials () - Jun 18, 2024 - Abstract #AHS2024AHS_337;
Pooled analysis of MOMENTUM and INTERCEPT indicates that AXS-07 was effective at acutely treating migraine with a favorable tolerability profile.
- meloxicam/rizatriptan (AXS-07) / Axsome Therap
Combined Efficacy and Safety of AXS-07 (MOSEICTM Meloxicam and Rizatriptan) in Two Phase 3 Clinical Trials (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3618;
Pooled analysis of MOMENTUM and INTERCEPT indicates that AXS-07 was effective at acutely treating migraine with a favorable tolerability profile. Pooled analysis of MOMENTUM and INTERCEPT indicates that AXS-07 was effective at acutely treating migraine with a favorable tolerability profile.
- meloxicam/rizatriptan (AXS-07) / Axsome Therap
EMERGE Study: An Open-label Evaluation of the Efficacy and Safety of AXS-07 (MoSEIC (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3413;
P3
Participants must have been using an oral CGRP inhibitor (rimegepant or ubrogepant). This is the first study to investigate the effects of AXS-07 in patients with inadequate response to oral CGRP inhibitors, a difficult to treat patient population.
- meloxicam/rizatriptan (AXS-07) / Axsome Therap
Efficacy of AXS-07 (MOSEIC (Both in-person and online) - Mar 12, 2023 - Abstract #AAN2023AAN_4148;
to the median BMI (28.8 kg/m2), 23.3% vs. 11.0% (p<0.001) for presence of allodynia, 23.5% vs. 10.5% (p<0.001) for morning migraine, and 23.1% vs. 5.9% (p=0.004) for history of depression.The most common adverse events reported in the AXS-07 group were nausea (2.4%), somnolence (2.1%), and dizziness (1.9%). Conclusions Among patients with documented risk factors for non-response to acute migraine medication, treatment with AXS-07 resulted in a statistically significant greater percentage of patients achieving 2-hour pain freedom compared to placebo.
- meloxicam/rizatriptan (AXS-07) / Axsome Therap
Identifying Areas of Unmet Need Among People with Migraine with an Inadequate Response to Prior Acute Therapies: Results from the MOMENTUM trial (Both in-person and online) - Mar 12, 2023 - Abstract #AAN2023AAN_2774;
Conclusions Among patients with documented risk factors for non-response to acute migraine medication, treatment with AXS-07 resulted in a statistically significant greater percentage of patients achieving 2-hour pain freedom compared to placebo. Design/Methods The Phase 3 MOMENTUM trial (N=1594) assessed the efficacy and safety of AXS-07 (MoSEIC
- ||| meloxicam/rizatriptan (AXS-07) / Axsome Therap
NDA: $AXSM following a Type A meeting with the FDA it intends to resubmit its NDA for AXS-07 for the acute treatment of migraine in Q3'23. (Twitter) - Sep 29, 2022
- |||||||| meloxicam/rizatriptan (AXS-07) / Axsome Therap
New P3 trial: Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE) (clinicaltrials.gov) - Sep 22, 2022
P3, N=100, Recruiting, Sponsor: Axsome Therapeutics, Inc.
- meloxicam/rizatriptan (AXS-07) / Axsome Therap
Efficacy and Safety of AXS-07 (MoSEIC Meloxicam-Rizatriptan) for the Acute Treatment of Migraine: Results from the MOMENTUM Phase 3, Randomized, Double-blind, Active- and Placebo-controlled Trial (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_3852;
Design/Methods The Phase 3 MOMENTUM trial (N=1594) assessed the efficacy and safety of AXS-07 (MoSEIC AXS-07 produced favorable outcomes relative to placebo and relative to its individual components, Mlx and Riz.
- meloxicam/rizatriptan (AXS-07) / Axsome Therap
Long-Term Efficacy and Safety of AXS-07 (MoSEIC Meloxicam-Rizatriptan) for the Acute Treatment of Migraine: Results from the MOVEMENT Phase 3 Trial (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_3827;
AXS-07 produced favorable outcomes relative to placebo and relative to its individual components, Mlx and Riz. AXS-07 rapidly, substantially, and durably relieved migraine pain and MBS.
- meloxicam/rizatriptan (AXS-07) / Axsome Therap
Efficacy and Safety of AXS-07 (MoSEIC Meloxicam-Rizatriptan) for the Acute Treatment of Migraine: Results from the INTERCEPT Phase 3, Randomized, Double-blind, Placebo-controlled Trial (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_3287;
AXS-07 rapidly, substantially, and durably relieved migraine pain and MBS. Treatment with AXS-07 was superior to placebo on both coprimary endpoints and a number of secondary endpoints.
- meloxicam/rizatriptan (AXS-07) / Axsome Therap
[VIRTUAL] Long Term Efficacy and Safety of AXS-07 (MoSEIC™ Meloxicam-Rizatriptan) for the Acute Treatment of Migraine: Results from the MOVEMENT Phase 3 Trial () - Oct 21, 2021 - Abstract #ANA2021ANA_265;
AXS-07 rapidly, substantially, and durably relieved migraine pain and MBS over 12 months. These long-term data confirm the robust efficacy and well-tolerated safety profile of AXS-07 observed in controlled trials.
- meloxicam/rizatriptan (AXS-07) / Axsome Therap
[VIRTUAL] Treatment of migraine pain and associated symptoms with AXS-07: Results from MOVEMENT, a long-term efficacy and safety study () - Jun 4, 2021 - Abstract #AHS2021AHS_337;
AXS-07 was well tolerated after long-term episodic treatment with a safety profile consistent with that observed in previously reported controlled trials. These long-term data confirm the robust efficacy of AXS-07 observed in controlled trials, versus both rizatriptan alone and placebo, and demonstrate a long-term safety profile consistent with controlled trials.
- meloxicam/rizatriptan (AXS-07) / Axsome Therap
[VIRTUAL] Comparative efficacy of AXS-07 (MoSEIC Meloxicam/Rizatriptan) versus rizatriptan in the acute treatment of migraine () - Jun 4, 2021 - Abstract #AHS2021AHS_333;
AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine. The greater efficacy of AXS-07 over rizatriptan in this trial indicate that AXS-07 may help address the unmet need for more effective treatments for this debilitating neurological condition.
- meloxicam/rizatriptan (AXS-07) / Axsome Therap
[VIRTUAL] Efficacy and safety of AXS-07 (MoSEIC Meloxicam/Rizatriptan) in the acute treatment of migraine: Results from the INTERCEPT phase 3 randomized, double-blind, placebo-controlled trial () - May 16, 2021 - Abstract #AHS2021AHS_109;
In the INTERCEPT trial, early treatment with AXS-07 resulted in rapid and sustained efficacy compared to placebo. Specifically, robust efficacy with AXS-07 compared to placebo was demonstrated on freedom from migraine pain and symptoms, prevention of migraine pain progression, less use of rescue medication, and the ability to return to normal functioning.
- ||||||| meloxicam/rizatriptan (AXS-07) / Axsome Therap
Trial completion, Enrollment change: Open-Label Long-Term Safety Study of AXS-07 for the Acute Treatment of Migraine (clinicaltrials.gov) - Jan 11, 2021
P3, N=706, Completed, Sponsor: Axsome Therapeutics, Inc.
Specifically, robust efficacy with AXS-07 compared to placebo was demonstrated on freedom from migraine pain and symptoms, prevention of migraine pain progression, less use of rescue medication, and the ability to return to normal functioning. Recruiting --> Completed | N=300 --> 706
- ||| bupropion/dextromethorphan (AXS-05) / Axsome Therap, meloxicam/rizatriptan (AXS-07) / Axsome Therap
NDA: $AXSM NDA submissions for AXS-05 in depression expected in Jan'21 and for AXS-07 in migraine expected in Q1 (Twitter) - Nov 5, 2020
- ||||||| meloxicam/rizatriptan (AXS-07) / Axsome Therap
Trial completion: INTERCEPT: Initiating Early Control of Migraine Pain and Associated Symptoms (clinicaltrials.gov) - Oct 8, 2020
P3, N=302, Completed, Sponsor: Axsome Therapeutics, Inc.
Recruiting --> Completed | N=300 --> 706 Recruiting --> Completed
- [VIRTUAL] Efficacy and Safety of AXS-07 (MoSEIC™ Meloxicam/Rizatriptan) in the Acute Treatment of Migraine: Results from the MOMENTUM Phase 3, Randomized, Double-Blind, Active- and Placebo- Controlled Trial () - Sep 30, 2020 - Abstract #ANA2020ANA_353;
Recruiting --> Completed AXS-07 produced rapid, sustained, substantial and significant efficacy versus rizatriptan, MoSEIC™ meloxicam and placebo in the acute treatment of migraine in patients with a history of inadequate response.
- [VIRTUAL] Efficacy and Safety of AXS-07 (MoSEIC™ Meloxicam/Rizatriptan) in the Acute Treatment of Migraine: Results from the INTERCEPT Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial () - Sep 30, 2020 - Abstract #ANA2020ANA_349;
AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine. In the INTERCEPT trial, early treatment with AXS-07 substantially and significantly eliminated migraine pain, and substantially and significantly prevented progression of migraine pain beyond mild intensity, as compared to placebo.
- || MOMENTUM trial: Rizatriptan + meloxicam proprietary formulation shows promise in migraine. https://t.co/SKPpVH2hLX #AANAM (Twitter) - Jun 3, 2020
- [VIRTUAL] Efficacy and Safety of AXS-07 (MoSEIC™ Meloxicam/rizatriptan) in the Acute Treatment of Migraine: Results from the MOMENTUM Phase 3 Trial () - May 25, 2020 - Abstract #AHS2020AHS_44;
These positive efficacy findings translated into significantly reduced use of rescue medications with AXS-07 compared to the active comparators. AXS-07 was safe and well tolerated in this trial.
- meloxicam/rizatriptan (AXS-07) / Axsome Therap
Efficacy and Safety of AXS-07 for the Acute Treatment of Migraine: Results from the MOMENTUM (Maximizing Outcomes in Treating Acute Migraine) Phase 3 Randomized, Double-blind, Active- and Placebo-controlled Study. () - May 20, 2020 - Abstract #AAN2020AAN_5311;
- ||| bupropion/dextromethorphan (AXS-05) / Axsome Therap, meloxicam/rizatriptan (AXS-07) / Axsome Therap
NDA: $AXSM to submit an NDA for AXS-05 for the treatment of MDD and for AXS-07 for the acute treatment of migraine in Q4. (Twitter) - Apr 27, 2020
- ||| meloxicam/rizatriptan (AXS-07) / Axsome Therap
P3 data: $AXSM Announces AXS-07 Achieves Both Co-Primary Endpoints and Prevents Migraine Pain Progression in the INTERCEPT Phase 3 Trial in the Early Treatment of Migraine (Twitter) - Apr 6, 2020
- ||||||| meloxicam/rizatriptan (AXS-07) / Axsome Therap
Trial completion, Enrollment change: MOMENTUM: Maximizing Outcomes in Treating Acute Migraine (clinicaltrials.gov) - Jan 13, 2020
P3, N=1594, Completed, Sponsor: Axsome Therapeutics, Inc.
AXS-07 was safe and well tolerated in this trial. Active, not recruiting --> Completed | N=875 --> 1594
- |||||||||| meloxicam/rizatriptan (AXS-07) / Axsome Therap
New P3 trial: INTERCEPT: Initiating Early Control of Migraine Pain and Associated Symptoms (clinicaltrials.gov) - Nov 15, 2019
P3, N=300, Recruiting, Sponsor: Axsome Therapeutics, Inc.
- ||||| meloxicam/rizatriptan (AXS-07) / Axsome Therap
Enrollment closed, Trial completion date: MOMENTUM: Maximizing Outcomes in Treating Acute Migraine (clinicaltrials.gov) - Nov 14, 2019
P3, N=875, Active, not recruiting, Sponsor: Axsome Therapeutics, Inc.
Active, not recruiting --> Completed | N=875 --> 1594 Recruiting --> Active, not recruiting | Trial completion date: Mar 2020 --> Dec 2019
- | meloxicam/rizatriptan (AXS-07) / Axsome Therap
New P3 trial: Open-Label Long-Term Safety Study of AXS-07 for the Acute Treatment of Migraine (clinicaltrials.gov) - Aug 28, 2019
P3, N=300, Recruiting, Sponsor: Axsome Therapeutics, Inc.
- |||||||||| meloxicam/rizatriptan (AXS-07) / Axsome Therap
New P3 trial: MOMENTUM: Maximizing Outcomes in Treating Acute Migraine (clinicaltrials.gov) - Mar 29, 2019
P3, N=875, Recruiting, Sponsor: Axsome Therapeutics, Inc.