Jazz Pharmaceuticals plc has submitted a New Drug Application (NDA) to the US Food and Drug Administration seeking marketing approval for solriamfetol (JZP-110), an investigational medicine for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). The NDA was submitted on December 20, 2017.
“Excessive sleepiness due to narcolepsy or OSA can affect a person’s ability to function at work or at home, and many patients unfortunately might suffer for years before their condition is properly addressed,” says Karen Smith, MD, PhD, executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals, in a release. “Jazz is committed to addressing unmet needs in this area by improving awareness and accurate diagnosis of these conditions and by delivering meaningful treatment options.”
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 OSA.