 Drugs in Dev.
 Drugs in Dev.								 Sleep
Sleep
											 Phase III
Phase III
											
																			 Ireland
Ireland								
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Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Undisclosed
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 : Controlled Substance
Upfront Cash : Inapplicable
July 31, 2024
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
Details : FT218 is a drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Idiopathic Hypersomnia.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
July 29, 2024

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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 : Controlled Substance
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

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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 : Controlled Substance
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

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Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Undisclosed
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 : Controlled Substance
Upfront Cash : Inapplicable
March 22, 2023
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Undisclosed
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 : Controlled Substance
Upfront Cash : Inapplicable
January 24, 2023
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Undisclosed
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 : Controlled Substance
Upfront Cash : Inapplicable
April 25, 2022
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Undisclosed
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 : Controlled Substance
Upfront Cash : Inapplicable
July 13, 2020
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

An Open Label Study of FT218 in Subjects With Narcolepsy
Details : FT218 is a drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Narcolepsy.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
June 30, 2020

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Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Study Phase : Phase III
Sponsor : Undisclosed
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 : Controlled Substance
Upfront Cash : Inapplicable
April 27, 2020
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable


 
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