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Also known as AXS-05 (dextromethorphan-bupropion)
AXS-05 · 10 trials · 12 indications
The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver-rated questionnaire that assesses the frequency of agitation-related and disruptive behaviors in subjects with dementia. The scale contains 29 behaviors or items organized into four subscales: physically aggressive, physically non-aggressive, verbally aggressive, and verbally non-aggressive. The CMAI is administered by interviewing the caregiver and asking him or her to rate the frequency with which the subject manifests each behavior using a seven-point scale: 1=never (better outcome), 7=several times an hour (worse outcome). The CMAI total score is the sum of the scores for all of the items in the CMAI. CMAI total scores range from a minimum of 29 (better outcome) to a maximum of 203 (worse outcome).
Incidence of treatment-emergent adverse events following dosing with AXS-05
The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.
The MADRS is used to assess depressive symptomatology during the previous week. Subjects are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.
Smoking intensity refers to the number of cigarettes smoked per day.
A biochemical marker of smoking intensity.
Assessed by clinician-rated scales.
The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.
The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver-rated questionnaire that assesses the frequency of agitation-related and disruptive behaviors in subjects with dementia. The scale contains 29 behaviors or items organized into four subscales: physically aggressive, physically non-aggressive, verbally aggressive, and verbally non-aggressive. The CMAI is administered by interviewing the caregiver and asking him or her to rate the frequency with which the subject manifests each behavior using a seven-point scale: 1=never (better outcome), 7=several times an hour (worse outcome). The CMAI total score is the sum of the scores for all of the items in the CMAI. CMAI total scores range from a minimum of 29 (better outcome) to a maximum of 203 (worse outcome).
| Arm | Type | Description |
|---|---|---|
| AXS-05 | EXPERIMENTAL | Up to 12 weeks |
| Bupropion | EXPERIMENTAL | Up to 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Up to 12 weeks |
| AXS-05 (dextromethorphan-bupropion) | EXPERIMENTAL | * Up to 52 weeks in the open-label segment; * Up to 24 weeks in the randomized double-blind segment (if applicable) |
| Bupropion SR | ACTIVE_COMPARATOR | Participants will receive Bupropion SR (Bupropion Sustained Release) for 4 weeks and will be instructed to take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal. |
| Name | Type | Description |
|---|---|---|
| AXS-05 (dextromethorphan-bupropion) | DRUG | AXS-05 tablets, taken twice daily for 12 weeks. |
| Bupropion | DRUG | Bupropion tablets, taken twice daily for 12 weeks. |
| Placebo | DRUG | Placebo tablets, taken twice daily for 12 weeks. |
| AXS-05 | DRUG | AXS-05 tablets, taken twice daily |
| Bupropion SR | DRUG | Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal. |
Inclusion Criteria: * Male or female, aged 18 to 65 (inclusive) Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.
AXS-05 is an investigational small molecule being developed for treatment resistant depression, agitation in patients with dementia of the Alzheimer's type, major depressive disorder, and smoking cessation. It is also known as dextromethorphan-bupropion. The drug is in Phase 3 clinical development for these neurological and psychiatric conditions.
AXS-05 is a combination of dextromethorphan and bupropion. Dextromethorphan is an NMDA receptor antagonist and sigma-1 receptor agonist, while bupropion is a norepinephrine and dopamine reuptake inhibitor. This dual mechanism is being studied for its effects on depression and other neurological conditions.
AXS-05 is being developed by Axsome Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker AXSM. The company is conducting clinical trials to evaluate the drug for multiple indications including treatment resistant depression and agitation in Alzheimer's disease.
AXS-05 is in Phase 3 clinical development. It has received FDA designations including Priority Review, Breakthrough Therapy, and Orphan Drug designation. The drug is investigational and has not been approved by the FDA for any indication.
AXS-05 has completed four clinical trials. These include NCT02741791 and NCT04019704, both Phase 3 studies in major depressive disorder, NCT03471767, a Phase 2 trial in smoking cessation, and NCT04608396, a Phase 2 mechanistic study in treatment resistant depression. Total enrollment across trials was 1,408 participants.
Yes, AXS-05 is also known as dextromethorphan-bupropion. It is a combination product containing these two active ingredients. The drug is being developed by Axsome Therapeutics for multiple psychiatric and neurological conditions.