Posted by Michael Wonder on 06 Mar 2018
Jazz Pharmaceuticals announces FDA acceptance of NDA for solriamfetol (JZP-110) for excessive sleepiness associated with narcolepsy or obstructive sleep apnea
2 March 2018 - Jazz Pharmaceuticals today announced that the U.S. FDA has accepted for filing with standard review the company's new drug application seeking marketing approval for solriamfetol, an investigational medicine for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea.
The Prescription Drug User Fee Act goal date for an FDA decision is 20 December 2018.
The solriamfetol Phase 3 clinical program includes one study evaluating excessive sleepiness in adult patients with narcolepsy (TONES 2), two studies evaluating excessive sleepiness in adult patients with OSA (TONES 3 and TONES 4), and an open-label, long-term safety and maintenance of efficacy study (TONES 5) in the treatment of excessive sleepiness in patients with narcolepsy or obstructive sleep apnea.
