Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Avadel Announces FDA Approval of LUMRYZ™ For Narcolepsy in Patients 7 And Older
Details : Lumryz is an extended-release oral suspension formulation of sodium oxybate being investigated for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy.
Product Name : Lumryz
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 17, 2024
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Avadel Announces First Patient Dosed in Phase 3 Trial of LUMRYZ for Idiopathic Hypersomnia
Details : Lumryz is an investigational, extended-release oral suspension formulation of sodium oxybate being investigated for the treatment of idiopathic hypersomnia.
Product Name : Lumryz
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 31, 2024
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Jefferies
Deal Size : $125.0 million
Deal Type : Public Offering
Avadel Pharmaceuticals Announces Pricing of Public Offering of ADSs and Series B Preferred Shares
Details : The offering will be used for obtaining FDA approval of company's lead candidate, Lumryz, an investigational, extended-release formulation of sodium oxybate for the treatment of cataplexy or EDS in adults with narcolepsy.
Product Name : Lumryz
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
March 29, 2023
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Jefferies
Deal Size : $125.0 million
Deal Type : Public Offering
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : RTW Investments
Deal Size : $75.0 million
Deal Type : Agreement
Avadel Pharmaceuticals Enters into Royalty Agreement with RTW Investments for up to $75 Million
Details : The financing will support the potential commercialization of Lumryz (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
Product Name : Lumryz
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
March 29, 2023
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : RTW Investments
Deal Size : $75.0 million
Deal Type : Agreement
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
Product Name : Lumryz
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 22, 2023
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
Product Name : Lumryz
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 24, 2023
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Presentation highlights results from a questionnaire assessing patient preference for once-nightly versus twice-nightly dosing regimen and another questionnaire assessing experiences with the second nightly dose in patients who switched from twice-nightl...
Product Name : Lumryz
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 25, 2022
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Study to examine the long-term safety and maintenance of efficacy in patients, and evaluate dosing and preference for patients switching from twice-nightly sodium oxybate to once-nightly FT218.
Product Name : Lumryz
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 13, 2020
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The primary analysis of FT218 demonstrated highly statistically significant (p<0.001), and clinically meaningful improvement across all three co-primary endpoints compared to placebo .
Product Name : Lumryz
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 27, 2020
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable