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Avadel Pharmaceuticals Avadel Pharmaceuticals Provides Corporate Update and Reports First Quarter 2021 Financial Results May 10 , 2021 • Announced FDA acceptance of NDA for once - nightly FT218 and an October 15 , 2021 target action PDUFA date • Presented positive secondary endpoint data at the AAN 2021 Annual Meeting , which further highlights the overall clinical value proposition of FT218 • FT218 launch preparation progressing • Management to host a conference call today at 8:30 a.m. ET DUBLIN , Ireland , May 10 , 2021 ( GLOBE NEWSWIRE ) -- Avadel Pharmaceuticals plc ( Nasdaq : AVDL ) , a company focused on developing FT218 , an investigational , once - nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy , today provided a corporate update and announced its financial results for the first quarter ended March 31 , 2021 . " We entered 2021 with positive momentum which included the announcement of several significant milestones for the FT218 program that will help shape our company's future , including FDA acceptance of the NDA filing for once - nightly FT218 , which was assigned a PDUFA target action date of October 15th . We are now approaching the mid - point of the review timeline and remain confident in our regulatory filing strategy . We also announced the appointment of Richard Kim as Chief Commercial Officer to lead the launch of FT218 , if approved . We are continuing to build our team and capabilities , and we are incredibly pleased with the experience and caliber of talent we are attracting to Avadel . We believe this is a testament to both confidence in the potential approval of FT218 and the opportunity that FT218 represents , " said Greg Divis , Chief Executive Officer of Avadel . " During the AAN annual meeting , we presented positive secondary endpoint data that further highlights the consistency with which once - nightly FT218 improved both subjective and objective symptoms of narcolepsy , as early as week three with the 6 g dose . Notably , the clinical data from the REST - ON phase 3 study presented at AAN shows that FT218 improved disturbed nocturnal sleep , with a single dose taken at bedtime . We believe the overwhelmingly positive data from this pivotal trial along with our Special Protocol Assessment agreement with FDA provides a strong foundation for our NDA , " said Dr. Jennifer Gudeman , Vice President of Medical and Clinical Affairs . " Educating the medical community on the clinical data from the REST - ON study is an important part of our broader strategy for FT218 . We will be presenting the secondary data and additional clinical data from the REST - ON study at future medical congresses , including the Associated Professional Sleep Societies ' annual SLEEP meeting , as well as publishing in peer - reviewed journals throughout the remainder of 2021 , " concluded Dr. Gudeman . First quarter and recent Company highlights • Announced that the New Drug Application ( NDA ) for FT218 was accepted for filing by the U.S. Food and Drug Administration ( FDA ) during the first quarter of 2021 , and was assigned a Prescription Drug User Fee Act ( PDUFA ) target action date of October 15 , 2021 • Presented positive secondary endpoint data from the REST - ON trial at the American Academy of Neurology ( AAN ) annual meeting , which further bolster the previously announced positive data regarding the three co - primary endpoints , including : • FT218 demonstrated significant consolidation of sleep , significant increase in time in deep sleep and significant decrease in light sleep compared to placebo , for all doses evaluated ( 6 g , 7.5 g , and 9 g ) , beginning by week three • FT218 demonstrated significant improvement in the Epworth Sleepiness Scale , a patient - reported outcome , as well as significantly improving patient perceptions of both the quality and refreshing nature of sleep , and a reduction of sleep paralysis , also for all doses evaluated ( 6 g , 7.5 g , and 9 g ) • Scheduled to present additional data from the REST - ON trial at the SLEEP congress in June 2021 • Continued the expansion and enrollment of the RESTORE open - label extension / switch study of FT218 designed to generate long - term safety , tolerability , and efficacy data , as well as data on switching from twice - nightly sodium oxybate and patient preference Overview of First Quarter Results As a result of the sale of the sterile injectable products to Exela Sterile Medicines LLC on June 30 , 2020 , the Company did not report any revenue for the quarter ended March 31 , 2021 , compared to $ 12.2 million for the same period in 2020 . R & D expenses were $ 3.9 million in the quarter ended March 31 , 2021 , compared to $ 5.5 million for the same period in 2020. The decrease on a year - over - year basis was primarily attributed to the completion of the Phase 3 REST - ON clinical study for FT218 , which concluded during the quarter ended March 31 , 2020 .