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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.
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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 .
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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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