Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 13 | PHASE3 | Atogepant |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1 |
| Ki Health Partners. LLC | RVNC | 1 | - | Daxibotulinumtonix A |
AXS-07 is an investigational small molecule being developed for the acute treatment of migraine in adults. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being studied for its ability to treat migraine symptoms, including pain and associated symptoms.
AXS-07 is being developed by Axsome Therapeutics, Inc., a biopharmaceutical company. Axsome Therapeutics is publicly traded under the ticker symbol AXSM. The company is conducting clinical trials to evaluate the safety and efficacy of AXS-07 for the acute treatment of migraine.
AXS-07 is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. All four completed clinical trials for AXS-07 were Phase 3 studies, which are typically the final stage of testing before a regulatory submission is considered.
AXS-07 has been studied in four completed Phase 3 clinical trials. These include NCT03896009, NCT04068051, NCT04163185, and NCT05550207. The trials enrolled a total of 2,702 participants with migraine and were conducted in the United States. All trials were randomized and double-blind, with placebo controls, except for the open-label EMERGE study.
AXS-07 is a distinct investigational drug and is not known to be the same as any other marketed medication. It is being studied specifically for the acute treatment of migraine. No alternative names for AXS-07 have been reported in the clinical trial information.