Sunosi(solriamfetol)

Sunosi (solriamfetol) is a drug reviewed under Application Number 211230Orig1s000 and 211230Orig2s000, with a review completion date of March 19, 2019. This New Drug Application (NDA) was submitted on December 20, 2017, and received on the same date, designated as a Standard review. The drug demonstrated a statistically significant effect compared to placebo for excessive daytime sleepiness (EDS) in narcolepsy and obstructive sleep apnea (OSA).

In Study 14-003 (OSA), solriamfetol 75 mg/day and 37.5 mg/day showed a statistically significant difference from placebo on co-primary endpoints. However, solriamfetol 75 mg/day did not demonstrate statistically significant improvement over placebo on co-primary endpoints in Study 14-002 (narcolepsy), and solriamfetol 37.5 mg/day did not succeed on a key secondary endpoint in Study 14-003. Solriamfetol can cause dose-related increases in systolic blood pressure, diastolic blood pressure, and heart rate. Discontinuation due to adverse events for combined solriamfetol was 7.3%, compared to 3.4% for placebo.