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Details:
sodium oxybate oral solution indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: Xyrem-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 03, 2023
Details:
Lumryz (sodium oxybate) is a once-nightly formulation of the USFDA approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: Lumryz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 05, 2023
Details:
Lumryz (sodium oxybate) is a once-nightly formulation of the USFDA approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: Lumryz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 2023
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.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: Lumryz
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies LLC
Deal Size: $125.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 29, 2023
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.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: Lumryz
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: RTW Investments
Deal Size: $75.0 million Upfront Cash: Undisclosed
Deal Type: Agreement March 29, 2023
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.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: Lumryz
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2023
Details:
Lumryz (sodium oxybate) is a sodium salt of GHB, a naturally occurring CNS depressant that increases dopamine levels and increases serotonin turnover. It is being developed for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: Lumryz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2023
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.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: Lumryz
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2023
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.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: Lumryz
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2022
Details:
In a human clinical study, Tris established about 100% bioavailability for one dose of its formulation against two doses of XYREM at 4.5 gm each, equivalent to the 9.0 gm maximum dose of sodium oxybate.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2022
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.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: Lumryz
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2022
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-nightly oxybates to FT218.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: FT218
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 25, 2022
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.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: FT218
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2022
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 with narcolepsy.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: FT218
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2021
Details:
FT218 demonstrated statistically significant improvement in EDS at all evaluated doses in narcolepsy patients with or without stimulant use, with improvement over placebo on MWT and CGI-I.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: FT218
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2021
Details:
REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: FT218
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2021
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.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: FT218
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 2020
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 .
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2020
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.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2020
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