FDA Authorizes Importation of Tentatively-Approved Narcolepsy Drug
The authorization allows the company to shorten the time to product availability following an anticipated final approval decision from the FDA.
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Sodium Oxybate Attributes: Does Once-Nightly Dosing Trump Low Sodium? Avadel Shares Its Findings
World Sleep 2022 attendees learned about results from an experiment about preferred attributes associated with oxybate treatments.
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Avadel Appoints Chief Commercial Officer to Lead Anticipated Launch of Once-Nightly Sodium Oxybate
Responsibilities include leading the US commercial launch of the company’s lead program, once-nightly FT218, pending regulatory approval.
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What We Know About Narcolepsy, Sodium Oxybate Use, Salt Intake & Cardiovascular Risk
A literature review from Stanford University looks at how the popular narcolepsy medication sodium oxybate impacts heart health.
Read MoreNarcolepsy Market Assessment: Once-Nightly Sodium Oxybate May Appeal to More Patients Than Just Those on Twice-Nightly Dosing
“Six out of 10 sodium oxybate-eligible patients are not going on therapy today, with twice-nightly dosing being the primary reason cited.”
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Avadel Transitions Leadership on Investigational Narcolepsy Drug
Jordan Dubow, MD, will be stepping down as chief medical officer of Avadel Pharmaceuticals to pursue another opportunity.
Read MoreAvadel Shares Additional Data from Phase 3 Trial of Potential Narcolepsy Drug
“We are at a pivotal point in Avadel’s transformation, as we recently completed our pre-NDA meeting with the FDA and are currently focused on completing our NDA submission and filing for FT218.”
Read MoreFirst Patient Dosed in Open-Label Extension/Switch Study of Investigational Narcolepsy Treatment
The study will enroll about 250 patients at most of the North American clinical trial sites that participated in the REST-ON study.
Read MoreAvadel Sells Off Sterile Injectable Drug Portfolio to Focus on Investigational Narcolepsy Drug Formulation
The sale of the sterile injectable drug portfolio is a significant milestone for the company, as it reflects a commitment to strategically focus on advancing FT218.
Read MoreAvadel Sees Positive Topline Results for Once-Nightly Sodium Oxybate for Narcolepsy in Phase 3 Trial
Avadel Pharmaceuticals plc announced positive topline data from its pivotal Phase 3 REST-ON trial assessing the safety and efficacy of FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.
Read MoreAvadel Completes REST-ON Phase 3 Trial of FT218 for Narcolepsy
Avadel Pharmaceuticals plc has completed the REST-ON Phase 3 clinical trial for FT218. The company expects to announce topline data from the study in the second quarter of 2020.
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Avadel Meets Revised Target Enrollment for Once-nightly Sodium Oxybate Phase 3 Study for Narcolepsy
Avadel Pharmaceuticals plc, a company focused on developing FT218, an investigational once-nightly...
Read MoreAvadel Gets FDA OK to Reduce Sample Size for Once-nightly Sodium Oxybate Phase 3 Study
Avadel Pharmaceuticals plc, a company focused on developing once-nightly sodium oxybate, FT218, for narcolepsy, reports that the U.S. Food and Drug Administration (FDA) has agreed to the company’s proposed amendments to...
Read MoreAvadel to Present New Data on Once-Nightly Sodium Oxybate at SLEEP 2019
Avadel Pharmaceuticals plc, a company focused on developing FT218 for narcolepsy, present two posters at SLEEP 2019. The posters highlight pharmacokinetic (PK) data for its investigational, once-nightly controlled-release sodium...
Read MoreAvadel Pharmaceuticals Makes Interim CEO Its New CEO
Avadel Pharmaceuticals plc, a company focused on developing FT218 for narcolepsy, has appointed Gregory J. Divis as CEO and member of the board of directors. Divis has served as interim CEO since January 2019. “Since being named...
Read MoreAvadel Pharmaceuticals Appoints Chief Medical Officer as Part of Plan to Give Investigational Narcolepsy Drug Best Chance of Success
Avadel Pharmaceuticals plc, a company focused on developing FT218 for sleep disorders, has appointed Jordan Dubow, MD, as chief medical officer. Dubow brings experience leading clinical development programs in sleep and...
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