Lumryz (sodium oxybate extended release) / Avadel 
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 0 Diseases   2 Trials   2 Trials   5 News 


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  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    Journal:  RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates. (Pubmed Central) -  Sep 12, 2024   
    P3
    Preference for extended-release, once-nightly sodium oxybate (ON-SXB, FT218) vs twice-nightly immediate-release (IR) oxybate was assessed in participants switching from IR oxybate to ON-SXB in an open-label/switch study, RESTORE (NCT04451668)...The second nightly IR oxybate dose presents significant treatment burdens and adherence concerns. Participants overwhelmingly preferred the once-nightly dosing regimen of ON-SXB.
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    Trial completion, Trial completion date, Trial primary completion date:  RESTORE: An Open Label Study of FT218 in Subjects With Narcolepsy (clinicaltrials.gov) -  Jan 29, 2024   
    P3,  N=184, Completed, 
    These findings demonstrate the robust efficacy of once-at-bedtime ON-SXB across participant subgroups. Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2023 --> Dec 2023
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    Journal:  Clinician Preferences for Oxybate Treatment for Narcolepsy: Survey and Discrete Choice Experiment. (Pubmed Central) -  Jun 19, 2023   
    A once-nightly bedtime dose of ON-SXB is a narcolepsy treatment option for people without the need for a middle-of-the-night dose of sodium oxybate. Clinicians indicated a significantly higher preference for the once-at-bedtime dosing schedule versus twice nightly in selecting oxybate therapies overall and when aiming to improve patient QoL or reduce patient anxiety.
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    P3 data, Retrospective data, Journal:  Efficacy of Once-Nightly Sodium Oxybate (FT218) in Narcolepsy Type 1 and Type 2: Post Hoc Analysis From the Phase 3 REST-ON Trial. (Pubmed Central) -  May 29, 2023   
    Clinicians indicated a significantly higher preference for the once-at-bedtime dosing schedule versus twice nightly in selecting oxybate therapies overall and when aiming to improve patient QoL or reduce patient anxiety. Clinically meaningful improvements of a single ON-SXB bedtime dose were shown for daytime sleepiness and DNS in NT1 and NT2, with less power for the limited NT2 subgroup.
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    Long-Term Safety of Once-Nightly Sodium Oxybate: Interim Analysis of Data From RESTORE (Both in-person and online) -  Mar 12, 2023 - Abstract #AAN2023AAN_2238;    
    P3
    Conclusions Thus far in RESTORE, ON-SXB is generally well tolerated, and no new safety signals have been observed. If approved, ON-SXB will offer a once-nightly oxybate treatment option for adults with narcolepsy.
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    Patient Preference and Nocturnal Experience With Oxybate Treatment for Narcolepsy: Interim Analysis of Data From RESTORE (Both in-person and online) -  Mar 12, 2023 - Abstract #AAN2023AAN_2237;    
    P3
    RESTORE, an ongoing open-label/switch study (NCT04451668), evaluates long-term safety/tolerability of investigational, extended-release once-nightly sodium oxybate (FT218; ON-SXB)...Most (90.8% [118/130]) arose from bed when waking for the second dose; 9 had falls and 5 reported injuries. Conclusions These data indicate patient preference for once-at-bedtime dosing and reveal the treatment burden of twice-nightly IR oxybate.
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    Patient and Provider Preferences for Oxybate Treatment for Narcolepsy: A Discrete Choice Experiment () -  Oct 17, 2022 - Abstract #ANA2022ANA_641;    
    Dosing frequency was identified as the most important attribute driving preference for overall product choice, QoL, and reducing patient anxiety/stress for both patients and HCPs with oncenightly preferred over twice-nightly dosing. If FDA approved, ON-SXB may fulfill an unmet need for a once-at-bedtime oxybate treatment.
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    Efficacy of Once-Nightly Sodium Oxybate (ONSXB; FT218) by Narcolepsy Type: Post-Hoc Analyses from the REST-ON Trial () -  Oct 17, 2022 - Abstract #ANA2022ANA_638;    
    P3
    Significant improvements in refreshing nature of sleep and ESS for ON-SXB vs placebo were reported for NT1 (all doses, P≤0.001) with directional improvements observed for the NT2 subgroup. Results of these subgroup analyses are generally consistent with previously reported REST-ON endpoints and support efficacy of ON-SXB for DNS, as well as daytime sleepiness, with a single bedtime dose in adults with either NT1 or NT2.
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    Enrollment closed, Enrollment change:  RESTORE: An Open Label Study of FT218 in Subjects With Narcolepsy (clinicaltrials.gov) -  Jun 14, 2022   
    P3,  N=175, Active, not recruiting, 
    ON-SXB conferred efficacy with a clearly beneficial single nighttime dose. Recruiting --> Active, not recruiting | N=250 --> 175
  • ||||||||||  Wakix (pitolisant) / Ferrer International, Paragon Biosci, sodium oxybate ER (FT218) / Avadel, Sunosi (solriamfetol) / Axsome Therap
    PATIENT AND HEALTHCARE PROVIDER SURVEYS OF NARCOLEPSY DISEASE BURDEN AND OXYBATE TREATMENT EXPERIENCE () -  Jun 6, 2022 - Abstract #SLEEP2022SLEEP_952;    
    While both individuals with narcolepsy and HCPs are relatively satisfied with current narcolepsy treatments, both groups are less satisfied with the dosing frequency of currently approved oxybate formulations. ON-SXB will be an additional treatment option that can address this unmet need.
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    PATIENT AND PROVIDER PREFERENCES FOR OXYBATE TREATMENT FOR NARCOLEPSY: A DISCRETE CHOICE EXPERIMENT () -  Jun 6, 2022 - Abstract #SLEEP2022SLEEP_951;    
    Support (If Any): Avadel Pharmaceuticals Introduction: Currently available immediate-release sodium oxybate (SXB) and mixed-salt oxybates are dosed twice nightly (second 2.5–4 hours after first)... Dosing frequency was identified as the most important attribute driving preference for overall product choice, QoL, and reducing patient anxiety/stress for both patients and HCPs with once-nightly preferred over twice-nightly dosing.
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    EFFICACY OF ONCE-NIGHTLY SODIUM OXYBATE (ON-SXB; FT218) FOR EXCESSIVE DAYTIME SLEEPINESS AND CATAPLEXY: POST-HOC NUMBER NEEDED TO TREAT AND EFFECT SIZE ANALYSES FROM REST-ON () -  Jun 6, 2022 - Abstract #SLEEP2022SLEEP_950;    
    P3
    Considering these post-hoc analyses may be useful to clinicians in discussing treatment expectations and provide support for the efficacy of ON-SXB for excessive daytime sleepiness and cataplexy in adults with narcolepsy.NNT calculations show that 3–6 patients need to be treated with ON-SXB to achieve ≥5 minutes increased sleep latency on the MWT, ESS score ≤10, or a ≥50% reduction in cataplexy. Considering these post-hoc analyses may be useful to clinicians in discussing treatment expectations and provide support for the efficacy of ON-SXB for excessive daytime sleepiness and cataplexy in adults with narcolepsy.
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    Journal:  Preferences for Attributes of Sodium Oxybate Treatment: A Discrete Choice Experiment in Patients with Narcolepsy. (Pubmed Central) -  Apr 19, 2022   
    Once-nightly SXB (ON-SXB; FT218) is under FDA review to treat adults with narcolepsy...Among the choices presented, dosing frequency was the most important attribute for overall product choice, likelihood to take medication exactly as directed, and reducing anxiety/stress. The ON-SXB blinded profile was significantly preferred over twice-nightly SXB.
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    Efficacy of Once-Nightly Sodium Oxybate (ON-SXB; FT218) By Narcolepsy Type: Post-hoc Analyses From the REST-ON Trial (Concourse / Mezzanine) -  Feb 26, 2022 - Abstract #WSS2022WSS_1064;    
    P3
    Lack of statistical significance on some endpoints for the NT2 subgroup may be due to underpowering. The results of these post-hoc analyses are generally consistent with the previously reported positive endpoints from REST-ON and provide further support for the efficacy of ON-SXB as a treatment for narcolepsy symptoms in adults with either NT1 or NT2.
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    Early Efficacy With Once-Nightly Sodium Oxybate (ON-SXB; FT218): Post-hoc Analyses From REST-ON (Concourse / Mezzanine) -  Feb 26, 2022 - Abstract #WSS2022WSS_89;    
    P3
    ON-SXB demonstrated improvement vs placebo in subjective measures of daytime sleepiness and in sleep quality and refreshing nature of sleep as early as week 1. If approved, ON-SXB will be a treatment option that may provide early relief of narcolepsy symptoms for some patients.
  • ||||||||||  Review, Journal:  Recently Approved and Upcoming Treatments for Narcolepsy. (Pubmed Central) -  Jun 10, 2021   
    Several new agents are being developed and tested as potential treatments for EDS and cataplexy associated with narcolepsy; these agents include novel oxybate formulations (once-nightly [FT218]; low sodium [JZP-258]), a selective norepinephrine reuptake inhibitor (AXS-12), and a product combining modafinil and an astroglial connexin inhibitor (THN102). This review summarises the mechanisms of action, pharmacokinetics, efficacy, and safety/tolerability of recently approved and emerging treatments for narcolepsy.
  • ||||||||||  sodium oxybate ER (FT218) / Avadel
    Trial completion date, Trial primary completion date:  RESTORE: An Open Label Study of FT218 in Subjects With Narcolepsy (clinicaltrials.gov) -  Jun 8, 2021   
    P3,  N=250, Recruiting, 
    This review summarises the mechanisms of action, pharmacokinetics, efficacy, and safety/tolerability of recently approved and emerging treatments for narcolepsy. Trial completion date: Jun 2022 --> Jun 2023 | Trial primary completion date: Jun 2022 --> Jun 2023