Jazz Pharmaceuticals submits Solriamfetol NDA with US FDA for narcolepsy or obstructive sleep apnea.
M2 EQUITYBITES-March 5, 2018-Jazz Pharmaceuticals submits Solriamfetol NDA with US FDA for narcolepsy or obstructive sleep apnea
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Biopharmaceutical company Jazz Pharmaceuticals plc (Nasdaq:JAZZ) said on Friday that it has successfully filed its New Drug Application (NDA) with the US Food and Drug Administration (FDA ) seeking marketing approval for solriamfetol for the treatment of obstructive sleep apnea (OSA).
In conjunction, the Prescription Drug User Fee Act (PDUFA) goal date for solriamfetol for an US FDA decision is 20 December 2018, added the company.
Jazz Pharmaceuticals said solriamfetol (JZP-110) is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in development for the treatment of excessive sleepiness in adult patients with narcolepsy, OSA, and Parkinson's disease.
The company added that solriamfetol Phase 3 clinical programme 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.
OSA is a prevalent disease (as high as 14% in men and 5% in women) with excessive sleepiness being a major presenting complaint in many cases. Excessive sleepiness in OSA is associated with impairments in cognitive function, safety, productivity, interpersonal relationships and overall quality of life. Narcolepsy is a debilitating neurological disorder characterized by excessive sleepiness and the inability to regulate sleep-wake cycles normally.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Mar 5, 2018|
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