Summary: The FDA has denied a citizen petition filed by a short seller challenging the safety and effectiveness of Wakix (pitolisant) for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. The FDA reaffirmed Wakix’s favorable benefit-risk profile and … [Read more...]
FDA Approves Non-Scheduled Narcolepsy Drug for Children
Summary: The FDA has expanded the approval of a narcolepsy drug, previously approved for adults, to now include children aged 6 and older. This new approval provides a non-scheduled treatment option for pediatric patients experiencing excessive daytime sleepiness due to … [Read more...]
Alkermes to Present Data for ALKS 2680 in Narcolepsy Treatment | Sleep Review
Summary: Alkermes plc introduced plans to present 3 posters at Rest 2024, showcasing the probable positive aspects of its investigational orexin 2 receptor agonist, ALKS 2680, for narcolepsy therapy. Displays will consist of information from a period 1b research, the layout of … [Read more...]
Mazindol Shows Neuroprotective Benefits in Narcolepsy Treatment
Summary: NLS Pharmaceutics Ltd will present a preclinical review at the ASCP convention exhibiting that mazindol, administered at 3 mg/kg, mitigated circadian exercise disruption in rats with narcoleptic-like indications induced by orexin-B-saporin lesions. The examine discovered … [Read more...]
Avadel to Present Data on Lumryz for Narcolepsy at SLEEP 2024
Summary: At Sleep 2024, Avadel will present new data on Lumryz, the initially extended-launch, when-nightly formulation of sodium oxybate for narcolepsy. Findings highlighted client preference for Lumryz around twice-nightly oxybate, with 94% preferring when-nightly dosing and … [Read more...]
Avadel Reports Uptick in Lumryz Therapy Adoption for Narcolepsy
Summary: Avadel Prescription drugs reported a considerable improve in Lumryz use for narcolepsy, with around 1,700 individuals initiating therapy—a 70% rise considering the fact that December. The enterprise is searching to expand Lumryz’s indications into pediatric treatment … [Read more...]
Orexin-2 Receptor Agonist for Narcolepsy Enters Phase 2 Trials
Summary: Alkermes plc has launched the Vibrance-1 examine, a stage 2 medical trial to evaluate the basic safety and efficacy of ALKS 2680, a novel orexin-2 receptor agonist, in treating narcolepsy type 1. This oral treatment method aims to boost wakefulness by focusing on the … [Read more...]
FDA OKs Phase 1 Trial of Narcolepsy Drug Candidate ORX750
Summary: Centessa Prescription drugs has received Food and drug administration authorization to commence a section 1 demo of ORX750, an investigational oral therapy aimed at narcolepsy and other slumber-wake conditions. ORX750, a selective orexin receptor 2 agonist, addresses the … [Read more...]
ALKS 2680 Improves Wakefulness in Narcolepsy Type 2 and IH
Summary: Alkermes plc introduced favourable benefits from a phase 1b research evaluating ALKS 2680, an oral orexin 2 receptor agonist, for dealing with narcolepsy variety 2 and idiopathic hypersomnia. The analyze showed statistically sizeable enhancements in wakefulness and rest … [Read more...]
Jazz to Highlight Narcolepsy and IH Research at AAN 2024
Summary: Jazz Prescribed drugs will existing five abstracts at the 76th Once-a-year American Academy of Neurology Conference in Denver that aim on narcolepsy and idiopathic hypersomnia. Essential conclusions include things like a authentic-planet promises evaluation demonstrating … [Read more...]