FDA Accepts Solriamfetol NDA for Narcolepsy-, OSA-Related Sleepiness
The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for solriamfetol (Jazz Pharmaceuticals), an investigational treatment for excessive sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
The Phase 3 clinical program for solriamfetol, a selective dopamine and norepinephrine reuptake inhibitor (DNRI), includes 1 study evaluating adults with narcolepsy (TONES 2), 2 studies involving patients with OSA (TONES 3 and TONES 4) and an open-label, long-term safety and efficacy study (TONES 5) in patients with narcolepsy or OSA. A separate trial is also investigating solriamfetol for the treatment of excessive sleepiness associated with Parkinson's disease.
Specifically for the narcolepsy and OSA indications, the FDA has set a Prescription Drug User fee Act (PDUFA) date for December 20th, 2018.
For more information visit JazzPharma.com.