Sleep | Phase III Developments | Pipeline Prospector

Syneos Health

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United States

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TIDES - 2020

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Idorsia Selects Syneos Health as Commercialization Partner to Launch Daridorexant in the United States

Lead Product(s): Daridorexant

Therapeutic Area: Sleep Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Syneos Health

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration August 31, 2020

Details:

The strategic collaboration brings Idorsia’s lead investigational compound, daridorexant, and expertise in the science of the orexin system, together with Syneos Health’s robust customer-facing sales expertise and proven track record in launching new products in the US.

Idorsia Pharmaceuticals

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Switzerland

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TIDES - 2020

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Daridorexant Phase 3 Results In Insomnia to be Presented at Sleep 2020

Lead Product(s): Daridorexant

Therapeutic Area: Sleep Product Name: ACT-541468

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 August 13, 2020

Details:

Results from the first pivotal Phase 3 study investigating 25 and 50 mg doses of its dual orexin receptor antagonist, daridorexant, in adult and elderly patients with insomnia, are to be presented at SLEEP 2020.

Idorsia Pharmaceuticals

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Switzerland

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TIDES - 2020

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Idorsia Japan Confirms Daridorexant Dose Response in Japanese Patients with Insomnia

Lead Product(s): Daridorexant

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 August 06, 2020

Details:

Treatment with daridorexant in 47 adult patients (ranging from 16 to 64 years) showed a significant dose-dependent decrease in WASO at Day 1 & 2 (average decrease of wake time after sleep onset from baseline on the 2 nights of treatment.

Avadel Pharmaceuticals

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IRELAND Ireland

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TIDES - 2020

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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.

Idorsia Pharmaceuticals

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Switzerland

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TIDES - 2020

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Second PhIII Study for Idorsia's Sleep Drug Returns Positive Results

Lead Product(s): Daridorexant

Therapeutic Area: Sleep Product Name: ACT-541468

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 06, 2020

Details:

The study confirms the findings of the first pivotal study, demonstrating efficacy of treatment with daridorexant on objective and subjective sleep parameters and showed positive effects on daytime functioning, with patients reporting no morning sleepiness and other symptoms.

Avadel Pharmaceuticals

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IRELAND Ireland

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TIDES - 2020

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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 .

Idorsia Pharmaceuticals

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Switzerland

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TIDES - 2020

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Idorsia's Rival to Merck's Insomnia Drug Clears Phase 3 Test

Lead Product(s): Daridorexant

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 20, 2020

Details:

The study demonstrated efficacy of treatment with daridorexant on objective and subjective sleep parameters and daytime performance with no residual effect in the morning.

Jazz Pharmaceuticals

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IRELAND Ireland

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TIDES - 2020

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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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Phase III

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Syneos Health

Idorsia Selects Syneos Health as Commercialization Partner to Launch Daridorexant in the United States

Idorsia Pharmaceuticals

Daridorexant Phase 3 Results In Insomnia to be Presented at Sleep 2020

Idorsia Pharmaceuticals

Idorsia Japan Confirms Daridorexant Dose Response in Japanese Patients with Insomnia

Avadel Pharmaceuticals

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

Idorsia Pharmaceuticals

Second PhIII Study for Idorsia's Sleep Drug Returns Positive Results

Avadel Pharmaceuticals

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

Idorsia Pharmaceuticals

Idorsia's Rival to Merck's Insomnia Drug Clears Phase 3 Test

Jazz Pharmaceuticals

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