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- 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.
- || sodium oxybate ER (FT218) / Avadel
Clinical, PK/PD data, Journal: Pharmacokinetics of FT218, a Once-Nightly Sodium Oxybate Formulation in Healthy Adults. (Pubmed Central) - Oct 27, 2021
Once-nightly FT218 at 4.5 and 6 g had lower overall C and C and similar exposure and variability compared with twice-nightly SO. FT218 was generally well tolerated and comparable to twice-nightly SO.
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] Weight Loss with FT218, a Once-Nightly Sodium Oxybate Formulation (ON-SXB), for the Treatment of Narcolepsy: Post Hoc Analysis from REST-ON () - Oct 21, 2021 - Abstract #ANA2021ANA_505;
Patients receiving ON-SXB experienced a sig nificantly greater decrease in weight and BMI vs placebo. These results suggest that treatment with once-nightly ON SXB may provide weight-related benefit for patients with nar colepsy and comorbid weight gain.
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] Efficacy of FT218, a Once-Nightly Sodium Oxybate Formulation (ON-SXB), by Stimulant Use: Post Hoc Analysis from REST-ON () - Oct 21, 2021 - Abstract #ANA2021ANA_504;
ON-SXB had similar efficacy on EDS at all evaluated doses in narcolepsy patients with or without stimu lant use, with improvement over placebo on MWT, DNS, and CGI-I. ON-SXB may provide effective treatment for EDS and DNS in patients with narcolepsy regardless of con comitant stimulant use.
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] Efficacy of FT218, a Once-Nightly Sodium Oxybate Formulation (ON-SXB), by Narcolepsy Subtype: Post Hoc Analysis from REST-ON () - Oct 21, 2021 - Abstract #ANA2021ANA_498;
In post hoc subgroup analyses by narcolepsy subtype, ON-SXB had similar efficacy on EDS in NT1 and NT2 with improvement in MWT, DNS, and CGI-I greater than placebo. ON-SXB may provide effective treatment for EDS and DNS in patients with narcolepsy, with or without cataplexy.
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] SLEEP LATENCY RESPONSE WITH FT218, A ONCE-NIGHTLY SODIUM OXYBATE: POST-HOC RESPONDER ANALYSES FROM THE PHASE 3 REST-ON CLINICAL TRIAL () - Oct 13, 2021 - Abstract #CHEST2021CHEST_2422;
P3
This improvement was evident as early as week 3 at the 6-g dose and continued to improve for the 7.5- and 9-g doses at week 8 and 13, respectively. CLINICAL IMPLICATIONS: ON-SXB is an efficacious treatment for daytime sleepiness in adults with narcolepsy.
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] CATAPLEXY RESPONSE WITH FT218, A ONCE-NIGHTLY SODIUM OXYBATE: POST-HOC RESPONDER ANALYSES FROM THE PHASE 3 REST-ON CLINICAL TRIAL () - Oct 13, 2021 - Abstract #CHEST2021CHEST_2412;
P3
A significantly greater proportion of participants who received ON-SXB treatment vs placebo experienced reductions in the number of weekly cataplexy attacks at once-nightly doses of 6, 7.5 and 9 g. Importantly, ~10% of patients taking the 2 highest doses of ON-SXB had complete elimination of their cataplexy. CLINICAL IMPLICATIONS: ON-SXB may be an effective treatment for cataplexy in adults with narcolepsy.
- || 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, Sponsor: Avadel
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
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] Weight Loss With FT218, a Once-Nightly Sodium Oxybate Formulation for the Treatment of Narcolepsy: Post Hoc Analysis From REST-ON () - May 17, 2021 - Abstract #SLEEP2021SLEEP_742;
Conclusion Patients receiving FT218 experienced a significantly greater decrease in weight and BMI vs placebo. These results suggest that treatment with once-nightly FT218 may provide weight-related benefit for patients with narcolepsy and comorbid weight gain.
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] Efficacy of FT218, a Once-Nightly Sodium Oxybate Formulation, by Stimulant Use: A Post Hoc Analysis From the REST-ON Study () - May 17, 2021 - Abstract #SLEEP2021SLEEP_741;
Conclusion FT218 had similar efficacy on EDS at all evaluated doses in narcolepsy patients with or without stimulant use, with improvement over placebo on MWT and CGI-I. FT218 may provide effective treatment for EDS in patients with narcolepsy regardless of stimulant use.
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] Efficacy of FT218, a Once-Nightly Sodium Oxybate Formulation, by Narcolepsy Subtype: A Post Hoc Analysis From the REST-ON Study () - May 17, 2021 - Abstract #SLEEP2021SLEEP_740;
Conclusion FT218 had similar efficacy on EDS at evaluated doses in NT1 and NT2, with improvement in MWT and CGI-I greater than placebo. FT218 may provide effective treatment for EDS in patients with narcolepsy, with or without cataplexy.
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] Efficacy of FT218 on Polysomnographic Measures of Sleep Continuity in Patients With Narcolepsy: Results From the REST-ON Trial () - May 17, 2021 - Abstract #SLEEP2021SLEEP_739;
FT218 was generally well tolerated; the most common adverse events were consistent with known SO side effects. FT218 could offer a new once-nightly treatment option for DNS in patients with narcolepsy as demonstrated by PSG measures.
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation, in Patients With Narcolepsy: REST-ON Primary Results () - May 17, 2021 - Abstract #SLEEP2021SLEEP_738;
Conclusion All evaluated doses of FT218 showed significant improvement vs placebo in mean sleep latency on MWT, CGI-I, and weekly NCAs. FT218 was generally well tolerated and the most common adverse events were consistent with known side effects of SO.
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] REST-ON: Efficacy of FT218 for Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients With Narcolepsy () - May 17, 2021 - Abstract #SLEEP2021SLEEP_737;
Conclusion At all evaluated doses, treatment with FT218 significantly improved EDS, sleep quality/refreshing nature of sleep, and SP vs placebo. FT218 was generally well tolerated; the most common adverse events were consistent with known SO side effects.
- || Clinical, Review, Journal: Clinical Characteristics of Cataplectic Attacks in Type 1 Narcolepsy. (Pubmed Central) - Apr 28, 2021
Cataplexy remains a challenge for children and adults with narcolepsy and can interfere with daily activities. There is no cure for narcolepsy, but cataplexy can be well-managed with current and promising new treatment options on the horizon.
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] Polysomnographic Measures of Sleep Continuity in Patients With Narcolepsy: Results From the REST-ON Trial, a Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation () - Mar 18, 2021 - Abstract #AAN2021AAN_2137;
FT218 was generally well tolerated, and the most common adverse reactions were well-known and established SO adverse reactions. FT218 could offer a new once-nightly treatment option for disrupted nighttime sleep in patients with narcolepsy as demonstrated by PSG measures.
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients With Narcolepsy: Results From the REST-ON Trial, a Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation () - Mar 18, 2021 - Abstract #AAN2021AAN_2136;
FT218 demonstrated significant and clinically meaningful results vs placebo at all doses tested for ESS, sleep quality/refreshing nature of sleep, and SP, representing improvement on important narcolepsy symptoms. FT218 was generally well tolerated, and the most common adverse reactions were well-known and established SO adverse reactions.
- | modafinil / Generic mfg.
Review, Journal: Advances in treatment of narcolepsy (Pubmed Central) - Oct 23, 2020
These new drugs include new hydroxybutyrate preparations (controlled release sodium hydroxybutyrate FT218, low sodium hydroxybutyrate JZP-258), selective norepinephrine reuptake inhibitor (AXS-12), and modafinil combined with astroglial junction protein inhibitor (THN102). This paper reviews the recently approved drugs and potential 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) - Jul 23, 2020
P3, N=250, Recruiting, Sponsor: Avadel
This paper reviews the recently approved drugs and potential treatments for narcolepsy. Trial completion date: Jun 2023 --> Jun 2022 | Trial primary completion date: Jun 2023 --> Jun 2022
- |||||||||| sodium oxybate ER (FT218) / Avadel
New P3 trial: RESTORE: An Open Label Study of FT218 in Subjects With Narcolepsy (clinicaltrials.gov) - Jun 29, 2020
P3, N=250, Recruiting, Sponsor: Avadel
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] STUDY DESIGN OF AN OPEN-LABEL EXTENSION AND SWITCH STUDY FOR ONCE NIGHTLY SODIUM OXYBATE, FT218, IN NT1 AND NT2 PATIENTS () - Jun 29, 2020 - Abstract #Sleep2020SLEEP_200;
The results of this open label extension/switch study will further elucidate the potential benefits of once-nightly FT218 regarding long term safety/tolerability, nocturnal safety/tolerability and efficacy, and importantly provide dosing and preference data for patients switching from twice-nightly SO to once-nightly FT218. Support: This work was supported by Avadel Pharmaceuticals
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] THE PHARMACOKINETICS OF FT218, ONCE NIGHTLY SODIUM OXYBATE: FOOD EFFECT AND BIOAVAILABILITY COMPARED TO TWICE NIGHTLY SODIUM OXYBATE () - Jun 29, 2020 - Abstract #Sleep2020SLEEP_199;
In the Fed state, AUC and Cmax of FT218 was lower than in the Fasted State. FT218 was generally safe and well tolerated and the safety profile appeared comparable to twice-nightly sodium oxybate.
- sodium oxybate ER (FT218) / Avadel
[VIRTUAL] THE PHARMACOKINETIC ADVERSE EVENT RELATIONSHIP FOR FT218, A ONCE-NIGHTLY SODIUM OXYBATE FORMULATION () - Jun 29, 2020 - Abstract #Sleep2020SLEEP_197;
There was no clear population toxicokinetic range for when AEs occur with FT218, but mostly individual thresholds. Since it appears AEs are related to Cmax, and FT218 only has one Cmax compared to two with the currently available product, it is hypothesized that FT218 will have a favorable safety profile compared to twice-nightly dosing.
- ||||||| sodium oxybate ER (FT218) / Avadel
Trial completion, Trial completion date, Trial primary completion date: Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy (clinicaltrials.gov) - Apr 3, 2020
P3, N=212, Completed, Sponsor: Avadel
Since it appears AEs are related to Cmax, and FT218 only has one Cmax compared to two with the currently available product, it is hypothesized that FT218 will have a favorable safety profile compared to twice-nightly dosing. Active, not recruiting --> Completed | Trial completion date: Sep 2020 --> Mar 2020 | Trial primary completion date: Sep 2020 --> Mar 2020
- | sodium oxybate ER (FT218) / Avadel, Xyrem (sodium oxybate) / Jazz, UCB, Bausch Health
But that twice a night $JAZZ #Xyrem is just awful for the REM cycle. Praying for $AVDL FT-218. (Twitter) - Mar 25, 2020
- sodium oxybate ER (FT218) / Avadel
The Pharmacokinetics of Once-Nightly Sodium Oxybate FT218: Food Effect and Relative Biovailability Compared to Twice-Nightly Sodium Oxybate () - Jan 21, 2020 - Abstract #AAN2020AAN_2333;
In the Fed state, AUC and Cmax of FT218 was lower than in the Fasted State. FT218 was generally safe and well tolerated and the safety profile appeared comparable to twice-nightly sodium oxybate.
- sodium oxybate ER (FT218) / Avadel
Pharmacokinetics and Dose Proportionality of FT218, a Once-Nightly Sodium Oxybate Formulation for the Treatment of Narcolepsy () - Jan 21, 2020 - Abstract #AAN2020AAN_2332;
FT218 was dose proportional for Cmax across the dosage range and slightly higher than dose proportional for AUCinf. The efficacy and safety of FT218 for the treatment of excessive daytime sleepiness and cataplexy in narcolepsy patients is currently being evaluated in the Phase 3 REST-ON pivotal study.
- sodium oxybate ER (FT218) / Avadel
The Pharmacokinetic-Adverse Event Relationship For FT218, a Once-Nightly Sodium Oxybate Formulation () - Jan 21, 2020 - Abstract #AAN2020AAN_2331;
There was no clear population toxicokinetic range for when AEs occur with FT218, but mostly individual thresholds. Since it appears AEs are related to Cmax, and FT218 only has one Cmax compared to two with the currently available product, it is hypothesized that FT218 will have a favorable safety profile compared to twice-nightly dosing.
- sodium oxybate ER (FT218) / Avadel
Pharmacokinetics and Formulation Selection of FT218, a Once-Nightly Sodium Oxybate Formulation for the Treatment of Narcolepsy () - Jan 21, 2020 - Abstract #AAN2020AAN_2330;
Prototype 2, compared to twice nightly sodium oxybate IR, exhibited a lower overall Cmax, a comparable C8h, and comparable AUC. The efficacy and safety of FT218 for the treatment of excessive daytime sleepiness and cataplexy in narcolepsy patients is currently being evaluated in the Phase 3 REST-ON pivotal study.
- ||||| sodium oxybate ER (FT218) / Avadel
Enrollment closed: Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy (clinicaltrials.gov) - Dec 11, 2019
P3, N=205, Active, not recruiting, Sponsor: Avadel
The efficacy and safety of FT218 for the treatment of excessive daytime sleepiness and cataplexy in narcolepsy patients is currently being evaluated in the Phase 3 REST-ON pivotal study. Recruiting --> Active, not recruiting
- sodium oxybate ER (FT218) / Avadel, Xyrem (sodium oxybate) / Jazz, UCB, Bausch Health
THE PHARMACOKINETICS OF ONCE-NIGHTLY CONTROLLED- RELEASE SODIUM OXYBATE (FT218): OVERVIEW OF RESULTS FROM FOUR PHASE 1 STUDIES (116-117) - Aug 20, 2019 - Abstract #WSS2019WSS_1555;
FT218 was generally safe and well tolerated and the safety profile appeared comparable to twice-nightly sodium oxybate IR. The efficacy and safety of FT218 in narcolepsy is currently being evaluated in the pivotal, randomized, double-blind, placebo-controlled Phase 3 REST-ON study.
- |||| sodium oxybate ER (FT218) / Avadel
Trial completion date, Trial primary completion date: Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy (clinicaltrials.gov) - May 9, 2019
P3, N=264, Recruiting, Sponsor: Flamel Ireland Limited
The efficacy and safety of FT218 in narcolepsy is currently being evaluated in the pivotal, randomized, double-blind, placebo-controlled Phase 3 REST-ON study. Trial completion date: Sep 2019 --> Sep 2020 | Trial primary completion date: Sep 2019 --> Sep 2020
- |||| sodium oxybate ER (FT218) / Avadel
Trial primary completion date: Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy (clinicaltrials.gov) - Jun 19, 2018
P3, N=264, Recruiting, Sponsor: Flamel Ireland Limited
Trial completion date: Sep 2019 --> Sep 2020 | Trial primary completion date: Sep 2019 --> Sep 2020 Trial primary completion date: Apr 2018 --> Sep 2019
- ||| Lumryz (sodium oxybate extended release) / Avadel
New P3 trial: A study to compare the absorption into the body of the drug sodium oxybate in FT218 in comparison to the currently marketed product Xyrem (EUDRACT) - Nov 14, 2017
P3, N=24, Ongoing, Sponsor: Flamel Ireland Ltd trading under the business name Avadel Ireland
- |||| sodium oxybate ER (FT218) / Avadel
Trial primary completion date: Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy (clinicaltrials.gov) - Aug 31, 2017
P3, N=264, Recruiting, Sponsor: Flamel Ireland Limited
Trial primary completion date: Apr 2018 --> Sep 2019 Trial primary completion date: Jan 2018 --> Apr 2018
- ||||| sodium oxybate ER (FT218) / Avadel
Trial initiation date, Trial primary completion date: Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy (clinicaltrials.gov) - May 25, 2017
P3, N=264, Recruiting, Sponsor: Flamel Ireland Limited
Trial primary completion date: Jan 2018 --> Apr 2018 Initiation date: Jul 2016 --> Nov 2016 | Trial primary completion date: Jul 2017 --> Jan 2018
- |||||| sodium oxybate ER (FT218) / Avadel
Enrollment open: Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy (clinicaltrials.gov) - Nov 3, 2016
P3, N=264, Recruiting, Sponsor: Flamel Ireland Limited
Initiation date: Jul 2016 --> Nov 2016 | Trial primary completion date: Jul 2017 --> Jan 2018 Not yet recruiting --> Recruiting
- || sodium oxybate ER (FT218) / Avadel
New P3 trial: Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy (clinicaltrials.gov) - Mar 28, 2016
P3, N=264, Not yet recruiting, Sponsor: Flamel Ireland Limited