Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Solriamfetol · 9 trials · 12 indications
An AE is defined as treatment emergent if the first onset or worsening is after the first administration of the study drug and not more than 7 days after the last dose of study drug or 30 days after the last dose of study drug for SAEs.
Adult ADHD Investigator Symptom Report Scale (AISRS)
MFIS score measured during the last three days of each 4-week medication period. The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue.
The observed maximum breast milk and plasma concentrations (Cmax) of solriamfetol after administration.
The time to reach the maximum breast milk and plasma concentrations (Tmax) of solriamfetol after administration.
The area under the plot of breast milk and plasma concentrations of solriamfetol against time after drug administration from predose (time 0) to Time t of the Last Quantifiable Concentration.
The area under the plot of breast milk and plasma concentrations of solriamfetol against time after drug administration from predose (time 0) to Infinity.
The half-life or the period of time required for the concentration of solriamfetol in breast milk and plasma to be reduced to one-half of the administered amount.
Apparent oral clearance (CL/F) of solriamfetol in plasma.
Apparent volume of distribution (Vd/F) of solriamfetol in plasma.
Area Under the concentration-time curve (AUC) in breast milk divided by AUC in plasma.
The amount of solriamfetol excreted in breast milk samples over 72 hours.
Daily solriamfetol dose that may be received by the infant through breastfeeding.
The percentage of the weight-adjusted maternal solriamfetol dose excreted in breast milk over 24 hours.
| Arm | Type | Description |
|---|---|---|
| Solriamfetol | EXPERIMENTAL | Up to 52 weeks |
| Solriamfetol 150mg | EXPERIMENTAL | * In the open-label period; * In the randomized double-blind period (if applicable) |
| Placebo | PLACEBO_COMPARATOR | • In the randomized double-blind period (if applicable) |
| Solriamfetol 300mg | EXPERIMENTAL | Up to 12 weeks |
| Solriamfetol 150 mg | EXPERIMENTAL | Up to 12 weeks |
| Solriamfetol 300 mg | EXPERIMENTAL | Up to 12 weeks |
| solriamfetol then placebo first | EXPERIMENTAL | Four weeks of treatment with solriamfetol followed by one week of washout and four weeks of treatment with placebo |
| placebo then solriamfetol first | EXPERIMENTAL | Four weeks of treatment with placebo followed by one week of washout and four weeks of treatment with solriamfetol |
| Name | Type | Description |
|---|---|---|
| Solriamfetol | DRUG | Solriamfetol capsules, taken once daily |
| Solriamfetol 150 MG | DRUG | Solriamfetol tablets, taken once daily |
| Placebo | DRUG | Placebo tablets, taken once daily |
| Solriamfetol 300 mg | DRUG | Solriamfetol tablets, taken once daily |
| Solriamfetol 150 mg Oral Tablet | DRUG | Single-dose 150 mg tablet orally administered. |
Inclusion Criteria: * Completed Study SOL-ADHD-302 (FOCUS-2) or Study SOL-ADHD-304 (FOCUS-3). * Has a parent/legal guardian to provide written informed consent and/or is willing to provide written informed assent to participate in the study. Exclusion Criteria: * Unable to comply with study proce...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
Solriamfetol is an investigational small molecule being studied for binge-eating disorder, ADHD, excessive sleepiness, major depressive disorder, major depressive disorder with excessive daytime sleepiness symptoms, and multiple sclerosis. It is in Phase 3 clinical development for several of these psychiatric and neurologic indications.
Solriamfetol targets the trace amine-associated receptor 1 (TAAR-1) and also affects dopamine and norepinephrine systems, as indicated by the trial title 'Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol.' This mechanism is being studied for its potential effects in depression and other conditions.
Solriamfetol is being developed by Axsome Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AXSM. The company is conducting clinical trials to evaluate the drug's efficacy and safety across multiple psychiatric and neurologic indications.
Solriamfetol is in Phase 3 clinical development for ADHD and major depressive disorder, with completed Phase 3 trials in these areas. It is also being studied in a Phase 2 trial for multiple sclerosis fatigue. The drug is investigational and not yet approved by regulatory authorities.
Solriamfetol has been studied in several clinical trials, including NCT05972044 (Phase 3, ADHD, completed, 516 participants), NCT06360419 (Phase 3, major depressive disorder, completed, 346 participants), NCT06170970 (Phase 2, multiple sclerosis fatigue, recruiting, 46 participants), and NCT07773883 (Phase 3, ADHD in children and adolescents, enrolling by invitation, 300 participants).
Yes, Solriamfetol 150 mg and Solriamfetol 150 MG refer to the same drug, solriamfetol, at a specific dosage strength. The drug is being developed by Axsome Therapeutics under the brand name solriamfetol, and the 150 mg formulation is one of the doses being evaluated in clinical trials.