Latest news with #EpworthSleepinessScale
Yahoo
7 days ago
- Business
- Yahoo
Avadel Pharmaceuticals plc (AVDL) Showcases LUMRYZ Success with 14 Abstracts, 4 Oral Presentations at SLEEP 2025
Avadel Pharmaceuticals plc (NASDAQ:AVDL) announced it will present 14 new abstracts, including four oral presentations, at SLEEP 2025, highlighting significant advances for LUMRYZ, its once-at-bedtime sodium oxybate treatment for narcolepsy. Interim results from the real-world REFRESH study showed that patients switching from twice-nightly oxybate to LUMRYZ experienced clinically meaningful improvements in excessive daytime sleepiness (EDS), with many achieving normal Epworth Sleepiness Scale (ESS) scores. A scientist in a labcoat examining a vial of experimental biopharmaceuticals. Additional analyses from the pivotal Phase 3 REST-ON trial revealed that even those with the most severe baseline sleepiness saw their ESS scores normalize after 13 weeks on LUMRYZ, and the therapy did not worsen sleep apnea. Further data demonstrated a reduction in distressing hallucinations and improvement in sleep-related eating disorder (SRED) symptoms after switching to LUMRYZ. Long-term tolerability was underscored, with only 4% discontinuing due to side effects. Avadel Pharmaceuticals plc (NASDAQ:AVDL) emphasized that LUMRYZ, FDA-approved for adults and children aged 7 and older, offers a major benefit over traditional oxybate by eliminating the need for middle-of-the-night dosing, supporting better sleep continuity and patient care. With these compelling results, Avadel Pharmaceuticals plc (NASDAQ:AVDL) continues to solidify its leadership in innovative narcolepsy treatments. While we acknowledge the potential of AVDL to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than AVDL and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None.
Yahoo
02-04-2025
- Health
- Yahoo
Alkermes begins Phase II trial of drug candidate for idiopathic hypersomnia
Irish biopharmaceutical company Alkermes has begun a randomised Phase II trial to assess the efficacy and safety of ALKS 2680 in adults with idiopathic hypersomnia (IH). The double-blind, placebo-controlled Vibrance-3 trial is expected to enrol a total of around 96 IH patients across sites in Australia, Europe and the US. Subjects will be randomised and given either 10mg, 14mg or 18mg of the therapy, or a placebo, once a day for eight weeks. Alkermes said that based on the dose level, the trial's primary endpoint will evaluate if the subjects taking the therapy experience a reduction in sleepiness against those who are taking only a placebo. This will be determined as per the measure of changes in the Epworth Sleepiness Scale (ESS) score. Subjects who complete the trial will be eligible to continue in an open-label, long-term safety trial. Alkermes Research & Development executive vice-president and chief medical officer Craig Hopkinson said: "The initiation of Vibrance-3 represents an important step forward for the ALKS 2680 development programme as we seek to advance a potential new treatment option for people living with idiopathic hypersomnia. "The Vibrance-3 Phase II study builds on encouraging data from our phase Ib, proof-of-concept study of ALKS 2680 in patients with IH, and we look forward to further characterising its safety and efficacy profile in this patient population." ALKS 2680 is an oral, selective orexin 2 receptor (OX2R) agonist being developed as a once-a-day treatment for narcolepsy type I and II, as well as IH–chronic, neurological conditions marked by 'excessive' daytime sleepiness. The ongoing Phase II studies, Vibrance-1 and Vibrance-2, are assessing the therapy's efficacy and safety in adults with narcolepsy type I and II respectively. Last year, Alkermes announced positive topline data from the narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) cohorts of a Phase Ib trial of ALKS 2680. "Alkermes begins Phase II trial of drug candidate for idiopathic hypersomnia" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
