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 disease.
Specifically for the narcolepsy and OSA indications, the FDA has set a Prescription Drug User fee Act (PDUFA) date for December 20th, 2018.
Jazz pharmaceuticals announces FDA acceptance of NDA for solriamfetol (JZP-110) for excessive sleepiness associated with narcolepsy or obstructive sleep apnea [press release]. Dublin: Jazz Pharmaceuticals. Published March 2, 2018. Accessed March 6, 2018.
This article originally appeared on MPR