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Also known as AXS-07 (meloxicam-rizatriptan)
AXS-07 · 4 trials · 1 indication
Absence of headache pain and without the use of rescue medication.
Absence of the most bothersome symptom, defined at the onset of migraine.
Absence of headache pain at Hour 2
Absence of Most Bothersome Symptom, defined at the onset of migraine at Hour 2
Long-term safety as measured by: Subjects with any TEAEs Subjects with suspected to be drug-related TEAEs Subjects with serious TEAEs Subjects with TEAEs that led to drug withdrawal Subjects with TEAEs that led to withdrawal from study Subjects with TEAEs that resulted in death
Absence of headache pain. AXS-07 vs Placebo.
Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo.
| Arm | Type | Description |
|---|---|---|
| AXS-07 (meloxicam-rizatriptan) | EXPERIMENTAL | Up to 8 weeks |
| AXS-07 | EXPERIMENTAL | Taken once upon migraine |
| Placebo | PLACEBO_COMPARATOR | Taken once upon migraine |
| Meloxicam | ACTIVE_COMPARATOR | Taken once upon a qualifying migraine |
| Rizatriptan | ACTIVE_COMPARATOR | Taken once upon a qualifying migraine |
| Name | Type | Description |
|---|---|---|
| AXS-07 (meloxicam-rizatriptan) | DRUG | AXS-07 tablets, taken orally for the acute treatment of migraine |
| AXS-07 (MoSEIC meloxicam and rizatriptan) | DRUG | AXS-07 tablet taken once upon the earliest onset of migraine pain. |
| Placebo | DRUG | Placebo tablet taken once upon the earliest onset of migraine pain. |
| AXS-07 | DRUG | AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine. |
| Meloxicam | DRUG | Meloxicam taken once upon onset of a qualifying migraine. |
| Rizatriptan | DRUG | Rizatriptan taken once upon onset of a qualifying migraine. |
Inclusion Criteria: * Has an established diagnosis of migraine with or without aura * Has experienced an inadequate response to oral CGRP inhibitors for the acute treatment of migraine Exclusion Criteria: * Pregnant, breastfeeding, or planning to become pregnant during the study * Has previously ...
Top 5 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 13 | PHASE3 | Atogepant, Ubrogepant, MEDI0618 |
| Pfizer Inc. | PFE | 11 | PHASE3 | Rimegepant, Zavegepant |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab |
| Evommune, Inc. | EVMN | 1 | PHASE2 | EVO756 |
AXS-07 is being developed for the acute treatment of migraine in adults. It is an investigational oral therapy studied in patients aged 18 years and older, including those who had an inadequate response to a prior oral CGRP inhibitor. All completed trials enrolled adults with migraine in the United States.
AXS-07 is being developed by Axsome Therapeutics, Inc., which trades on the Nasdaq under the ticker AXSM. Axsome is the sponsor of the clinical program evaluating AXS-07 for acute migraine treatment.
AXS-07 is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Four Phase 3 trials have been completed, including the EMERGE, MOVEMENT, and Maximizing Outcomes in Treating Acute Migraine studies, with no active trials currently listed.
AXS-07 has been studied in four completed Phase 3 trials: NCT05550207 (EMERGE), NCT04163185, NCT04068051 (MOVEMENT), and NCT03896009. These randomized, double-blind, placebo-controlled trials enrolled a total of 2,702 participants with migraine across sites in the United States.
AXS-07 is an investigational oral small molecule therapy for the acute treatment of migraine in adults. Its Phase 3 program included a study specifically evaluating AXS-07 in patients with a prior inadequate response to an oral CGRP inhibitor, alongside broader acute migraine trials.