Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies ( 14 )] . Limitations of Use SUNOSI is not indicated to treat the underlying airway obstruction in OSA. FDA label
Also known as Sunosi
Solriamfetol · 11 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.
Attention Deficit/ Hyperactivity Disorder Rating Scale-5, Interview with Informant, Child Version (ADHD-RS-5)
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 Dose A | EXPERIMENTAL | Up to 6 weeks |
| Solriamfetol Dose B | EXPERIMENTAL | Up to 6 weeks |
| Placebo | PLACEBO_COMPARATOR | Up to 6 weeks |
| Solriamfetol 150mg | EXPERIMENTAL | * In the open-label period; * 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 Dose A | DRUG | Solriamfetol capsules, taken once daily |
| Solriamfetol Dose B | DRUG | Solriamfetol capsules, taken once daily |
| Placebo | DRUG | Placebo capsules, taken once daily |
| Solriamfetol 150 MG | DRUG | Solriamfetol 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 |
| Axsome Therapeutics, Inc. | AXSM | 3 | PHASE3 | Solriamfetol |
Solriamfetol is a small molecule therapeutic being developed by Axsome Therapeutics, Inc. for psychiatric and neurological conditions. It is in Phase 3 clinical development across several indications, including ADHD, binge-eating disorder, excessive sleepiness, major depressive disorder, major depressive disorder with excessive daytime sleepiness symptoms, and multiple sclerosis.
Solriamfetol is being studied for ADHD, binge-eating disorder, excessive sleepiness, major depressive disorder, major depressive disorder with excessive daytime sleepiness symptoms, and multiple sclerosis. It is investigational and has not been established as a treatment for these conditions. Development is focused on psychiatric and central nervous system indications.
Solriamfetol targets DAT and NET, the dopamine transporter and norepinephrine transporter. By acting on these transporters, it affects dopamine and norepinephrine signaling in the central nervous system. This mechanism underlies its study in ADHD, excessive sleepiness, and mood-related conditions.
Solriamfetol is developed by Axsome Therapeutics, Inc., which trades on the Nasdaq under the ticker AXSM. The company is running the Phase 3 program for the drug across ADHD, major depressive disorder with excessive daytime sleepiness symptoms, and related indications.
Solriamfetol is in Phase 3 clinical development. It is investigational and is not approved for the indications being studied. The program includes four trials in total, with three currently active and one completed, and randomized, double-blind, placebo-controlled designs.
Solriamfetol is being evaluated in four Phase 3 trials. These include NCT07773883, an open-label long-term safety study in children and adolescents with ADHD; NCT07717892 (FOCUS-3) and NCT07717879 (FOCUS-2) in ADHD; and NCT07484217 in major depressive disorder with excessive daytime sleepiness symptoms. Total enrollment across the program is 1,752 participants.