Sleep | Phase III Developments | IRELAND

Avadel Pharmaceuticals

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IRELAND Ireland

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Avadel Pharmaceuticals Announces First Patient Dosed in Open-Label Extension/Switch Study of Investigational Once-Nightly FT218

Lead Product(s): Sodium Oxybate

Therapeutic Area: Sleep Product Name: FT218

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 13, 2020

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.

Avadel Pharmaceuticals

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IRELAND Ireland

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Avadel Pharmaceuticals Announces Positive Topline Results from its Pivotal Phase 3 REST-ON Trial of Once-Nightly FT218

Lead Product(s): Sodium Oxybate

Therapeutic Area: Sleep Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 27, 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 .

Jazz Pharmaceuticals

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IRELAND Ireland

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Jazz Pharmaceuticals Submits New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy

Lead Product(s): JZP-258

Therapeutic Area: Sleep Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 22, 2020

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.

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Find Drugs for Sleep in Phase III Clinical Development in IRELAND

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Avadel Pharmaceuticals

Avadel Pharmaceuticals Announces First Patient Dosed in Open-Label Extension/Switch Study of Investigational Once-Nightly FT218

Avadel Pharmaceuticals

Avadel Pharmaceuticals Announces Positive Topline Results from its Pivotal Phase 3 REST-ON Trial of Once-Nightly FT218

Jazz Pharmaceuticals

Jazz Pharmaceuticals Submits New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy