Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALKS 5461 · 16 trials · 6 indications
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of Major Depressive Disorder (MDD) symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
The HAM-D17 scale is a clinician-administered questionnaire comprised of 17 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.
Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461
Maximum observed plasma concentration for ALKS 5461
Area under the concentration time curve from time zero to the last measureable time point (AUC0-t) of ALKS 5461 in the presence and absence of itraconazole
Area under the concentration time curve from time zero to infinity (AUC0-inf) of ALKS 5461 in the presence and absence of itraconazole
Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole
The parameters for determining the bioavailability include Cmax, AUC last, and AUC(0-infinity).
Measured over a range of dose levels in subjects with inadequate/partial response to antidepressant therapy during the current episode of MDD.
| Arm | Type | Description |
|---|---|---|
| ALKS 5461 | EXPERIMENTAL | Sublingual tablets |
| ALKS 5461 Placebo | PLACEBO_COMPARATOR | Sublingual tablets |
| High Dose | EXPERIMENTAL | - |
| Low Dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Titration Schedule 1 | EXPERIMENTAL | - |
| Titration Schedule 2 | EXPERIMENTAL | - |
| Moxifloxacin | ACTIVE_COMPARATOR | Oral tablet |
| ALKS 5461 Dose 1 | EXPERIMENTAL | Sublingual tablets |
| ALKS 5461 Dose 2 | EXPERIMENTAL | Sublingual tablets |
| ALKS 5461 Dose 3 | EXPERIMENTAL | Sublingual tablets |
| Buprenorphine Dose 1 | ACTIVE_COMPARATOR | Sublingual tablets |
| Buprenorphine Dose 2 | ACTIVE_COMPARATOR | Sublingual tablets |
| Itraconazole | OTHER | Itraconazole or placebo |
| ALKS 5461-A | EXPERIMENTAL | - |
| ALKS 5461-B | EXPERIMENTAL | - |
| ALKS 5461 (ALKS 33 and buprenorphine) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ALKS 5461 | DRUG | Samidorphan + buprenorphine, administered sublingually |
| ALKS 5461 Placebo | DRUG | Placebo tablet, administered sublingually |
| Placebo | DRUG | Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
| High Dose ALKS 5461 | DRUG | Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
| Low Dose ALKS 5461 | DRUG | Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
| Moxifloxacin | DRUG | Single administration |
| Buprenorphine | DRUG | Sublingual tablets, single administration |
| Itraconazole | DRUG | Administered orally in a crossover design |
Inclusion Criteria: * Have a Major Depressive Disorder (MDD) primary diagnosis * Have a body mass index (BMI) of 18.0 to \</= 40.0 kg/m\^2 * Be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials) * Ha...
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ALKS 5461 is an investigational small molecule being studied for use in Major Depressive Disorder (MDD). It has also been evaluated in clinical trials involving healthy volunteers, pharmacokinetics, renal impairment, and hepatic impairment. The drug is being developed by Alkermes plc and is currently in Phase 1 clinical development.
ALKS 5461 is being developed by Alkermes plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALKS. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in various patient populations, including those with Major Depressive Disorder.
ALKS 5461 is currently in Phase 1 clinical development. While some earlier studies have been completed, the drug remains investigational and has not been approved by regulatory authorities. It is being studied for its potential use in treating Major Depressive Disorder and for pharmacokinetic evaluation in special populations.
ALKS 5461 has been studied in several completed clinical trials. These include NCT01381107, a Phase 1 safety and tolerability study in subjects with Major Depressive Disorder; NCT01500200, a Phase 2 study in MDD; NCT02452801, a pharmacokinetics study in hepatic impairment; and NCT02545439, a drug-drug interaction study in healthy volunteers.
Yes, ALKS 5461 is also known as ALKS 33-BUP. The drug has been referred to by this alternative name in clinical trial documentation, such as in the study titled 'ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD.' Both names refer to the same investigational compound.