Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Solriamfetol · 6 trials · 11 indications
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 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 300 mg | EXPERIMENTAL | Up to 6 weeks |
| Solriamfetol 150 mg | EXPERIMENTAL | Up to 6 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 |
| Solriamfetol | EXPERIMENTAL | Participants will receive a single oral dose of solriamfetol 150 mg with 240 mL water at 0 hour on the morning of Day 1, 2 hours after completion of a light breakfast. |
| Name | Type | Description |
|---|---|---|
| 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 | DRUG | solriamfetol 75 mg daily for 3 days and will increase the dose to 150 mg daily starting on day 4 of the treatment period (total of four weeks) |
| Solriamfetol 150 mg Oral Tablet | DRUG | Single-dose 150 mg tablet orally administered. |
Inclusion Criteria: * Currently meets the DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT * Excessive daytime sleepiness symptoms * Able to comply with study procedures * Male or female, aged 18 to 65 years inclusive Exclusion Criteria: * Any clinically significant medic...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |