Date: 2017-12-20
Type of information: Submission of a Market Application in the US
Product name: solriamfetol (JZP-110)
Compound: solriamfetol
Therapeutic area: Rare diseases
Action mechanism:
- dopamine and norepinephrine reuptake inhibitor (DNRI). JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in development for treatment of excessive sleepiness in adult patients with narcolepsy, OSA, and Parkinson's disease. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize JZP-110 from SK Biopharmaceuticals, which discovered the compound.
- Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to JZP-110, excluding certain jurisdictions in Asia . SK Biopharmaceuticals maintains rights in Korea , Japan , China , Taiwan , Singapore , Indonesia , India , Philippines ,Thailand , Malaysia , Vietnam , and Hong Kong . JZP-110 has orphan drug designation in the United States for narcolepsy.
- Across the entire JZP-110 development program, over 2,000 subjects have enrolled in 20 studies. The JZP-110 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. Enrollment is complete in all studies that are expected to support Jazz Pharmaceuticals' planned JZP-110 New Drug Application (NDA) submission to the FDA in late 2017.
Company: Jazz Pharmaceuticals (Ireland)
Disease: excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA)
Latest news:
- • On December 21, 2017, Jazz Pharmaceuticals announced the submission of a New Drug Application (NDA) to the FDA on December 20, 2017 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 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.
Patents:
Submission of marketing authorization application USA : 2017-12-20
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
