Lead Product(s) : Sodium Oxybate
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : LUMRYZ is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once-at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
Product Name : Lumryz
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 18, 2022
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Post-hoc analyses support positive results observed in completed Phase 3 REST-ON trial and demonstrated improvement in subjective measures of daytime sleepiness, sleep quality and refreshing nature of sleep with once-at-bedtime FT218 as early as week 1.
Product Name : Lumryz
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 03, 2022
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : LUMRYZ is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of EDS or cataplexy in adults with narcolepsy.
Product Name : Lumryz
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 19, 2022
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : FT218, also known as ON-SXB is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults wi...
Product Name : Lumryz
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 19, 2021
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Jazz Pharmaceuticals Announces FDA Acceptance of New Drug Application for JZP-258
Details : JZP-258 represents between 1,000 and 1,500 milligrams daily reduction of sodium for patients currently treated with Xyrem, depending on the dose.
Product Name : Xyrem
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 25, 2020
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : JZP-258
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The submission is based on a Phase 3 global randomized-withdrawal, multicenter study that demonstrated the efficacy and safety of JZP-258 in the treatment of narcolepsy.
Product Name : JZP-258
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 22, 2020
Lead Product(s) : JZP-258
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable