Takeda will provoke Section 3 trials after constructive outcomes from a randomized, double-blind, placebo-controlled, a number of dose Section 2b trial evaluating TAK-861, an oral orexin receptor 2 agonist, in sufferers with narcolepsy kind 1.
Lilly addresses use of weight reduction medicine (March 7)
Lilly addressed sure practices referring to its tirzepatide medicines (Mounjaro and Zepbound) to make sure they’re prescribed and used safely, noting they shouldn’t be used for beauty weight reduction or in sufferers beneath the age of 18.
Axsome presents new narcolepsy drug information (March 25)
Axsome Therapeutics introduced that AXS-12 (reboxetine) achieved the first endpoint and considerably decreased the frequency of cataplexy assaults in contrast with placebo in sufferers with narcolepsy in a Section 3 multicenter trial.
Zevra pronounces top-line information from Section 2 scientific trial of KP1077 for idiopathic hypersomnia (March 26)
Zevra Therapeutics introduced top-line information from its placebo-controlled, double-blind Section 2 scientific trial evaluating the security and tolerability of KP1077 (serdexmethylphenidate) in sufferers with idiopathic hypersomnia.
Alkermes pronounces outcomes from part 1b research of ALKS 2680 in narcolepsy, idiopathic hypersomnia (April 9)
Alkermes introduced constructive topline outcomes from a part 1b, proof-of-concept research evaluating ALKS 2680, the corporate’s novel, investigational, oral orexin 2 receptor agonist in growth as a as soon as every day therapy for narcolepsy.
Concord licenses new narcolepsy drug (April 11)
Concord Biosciences introduced an unique licensing settlement with Bioprojet to commercialize TPM-1116, a selective oral orexin-2 receptor agonist that might be evaluated for the therapy of narcolepsy and different sleep problems.
Tirzepatide decreased OSA severity by as much as practically two-thirds in adults with weight problems (April 17)
Eli Lilly introduced constructive topline outcomes of part 3 scientific trials exhibiting the injectable prescription drug Zepbound (tirzepatide) considerably decreased the AHI in comparison with placebo in adults with average to extreme OSA and weight problems.
Alkermes pronounces initiation of Vibrance-1 part 2 research evaluating ALKS 2680 for Narcolepsy kind 1 (April 24)
Alkermes introduced initiation of the Vibrance-1 research, a part 2 scientific trial evaluating the security and efficacy of ALKS 2680, a novel oral orexin 2 receptor agonist in growth as a as soon as every day therapy for narcolepsy kind 1.
Johnson & Johnson research of seltorexant reveals enchancment in depressive signs, sleep disturbance (Might 29)
Johnson & Johnson introduced constructive outcomes from a Section 3 scientific trial exploring the efficacy and security of seltorexant as an adjunctive therapy to antidepressants in adults with main depressive dysfunction with insomnia signs.
Incannex makes progress in OSA drug trial (Might 30)
Incannex Healthcare introduced that affected person dosing has commenced within the firm’s Section 2/3 scientific trial to evaluate security and efficacy in sufferers with sleep apnea of IHL-42X, which mixes low-dose dronabinol and acetazolamide.
What GLP-1 information may imply for OSA (June)
On this on-line replace, ResMed Chief Medical Officer Carlos Nunez takes a more in-depth take a look at what the newest GLP-1 information may imply for these with OSA, and he describes how combo remedy with remedy plus CPAP could also be optimum for therapy.
Zevra shares constructive outcomes for idiopathic hypersomnia drug (June 3)
At SLEEP in Houston, Zevra Therapeutics offered last constructive outcomes from its placebo managed, double blind Section 2 scientific trial evaluating the security and tolerability of KP1077 (SDX) in sufferers with idiopathic hypersomnia.
Takeda presents outcomes for narcolepsy drug (June 3)
Takeda offered constructive outcomes from its Section 2b trial of TAK-861 in narcolepsy kind 1 as late-breaking information displays on the SLEEP 2024 assembly in Houston. TAK-861 is an investigational oral orexin receptor 2 agonist.
Alkermes shares information from narcolepsy research (June 3)
Alkermes introduced information from the narcolepsy kind 1 cohort of a part 1b, proof-of-concept research evaluating ALKS 2680, a novel, investigational, oral orexin 2 receptor agonist in growth as a as soon as every day therapy for narcolepsy.
Concord presents information on Wakix for extreme daytime sleepiness in DM1 (June 5)
At SLEEP 2024 in Houston, Concord Biosciences offered information from its Section 2 sign detection research exhibiting that Wakix (pitolisant) decreased extreme daytime sleepiness and fatigue in adults with Myotonic dystrophy Sort 1 (DM1).
Tirzepatide for OSA and weight problems (June 21)
A research printed within the New England Journal of Drugs concerned two part 3, double-blind, randomized, managed trials of tirzepatide in adults with average to extreme OSA and weight problems. Remedy decreased the AHI and physique weight.
Lilly anticipates FDA motion on tirzepatide (June 21)
Eli Lilly has submitted tirzepatide for the therapy of moderate-to-severe OSA and weight problems to the FDA, and the corporate anticipates regulatory motion as early as the tip of this 12 months based mostly on the Quick Observe designation it already obtained.
FDA approves Wakix for pediatric narcolepsy (June 24)
Concord Biosciences introduced that the FDA has permitted its supplemental new drug utility for Wakix (pitolisant) tablets for the therapy of extreme daytime sleepiness in pediatric sufferers 6 years of age and older with narcolepsy.
Examine compares GLP-1 weight reduction medicine semaglutide and tirzepatide (July 8)
A cohort research of 18,386 matched sufferers discovered use of tirzepatide was related to considerably better weight reduction than semaglutide in adults who’re obese or overweight, based on a brand new research printed in JAMA Inside Drugs.
Pfizer advances growth of once-daily formulation of oral GLP-1 receptor agonist danuglipron (July 11)
Pfizer introduced that based mostly on outcomes from the continued pharmacokinetic research, the corporate has chosen its most popular once-daily modified launch formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist for weight problems.
Roche pronounces constructive Section I outcomes of oral GLP-1 receptor agonist CT-996 for the therapy of weight problems (July 17)
Roche introduced constructive topline outcomes from two arms of an ongoing multi-part Section I scientific trial for CT-996, an investigational, once-daily, oral small molecule GLP-1 receptor agonist being developed for the therapy of each kind 2 diabetes and weight problems.
First affected person dosed in Lumryz trial for idiopathic hypersomnia (July 31)
Avadel Prescribed drugs introduced that the primary affected person has been dosed in REVITALYZ, a multicenter part 3 research evaluating Lumryz (sodium oxybate) given as soon as at bedtime as a possible therapy for idiopathic hypersomnia in adults.
Avadel experiences weight reduction with Lumryz (Aug. 20)
Avadel introduced the publication of outcomes of a post-hoc evaluation from the finished pivotal part 3 REST-ON scientific trial demonstrating better weight reduction in sufferers with narcolepsy who obtained Lumryz (sodium oxybate) in contrast with placebo.
Alkermes pronounces Vibrance-2 part 2 research evaluating ALKS 2680 for therapy of narcolepsy (Aug. 22)
Alkermes introduced the initiation of the Vibrance-2 research, a part 2 scientific trial evaluating the security and efficacy of ALKS 2680 — a novel, once-daily, oral, selective orexin 2 receptor agonist — in adults with narcolepsy kind 2.
Avadel pronounces Lumryz research outcomes (Sept. 3)
Avadel introduced the publication of ultimate information from the RESTORE open-label swap research, demonstrating individuals with narcolepsy desire once-at-bedtime Lumryz versus a twice-nightly immediate-release oxybate therapy choice.
Sufferers present curiosity in switching to a tablet for OSA (Sept. 9)
Quantum Analysis Group introduced the outcomes of a brand new survey, “Understanding Obstructive Sleep Apnea Remedy Experiences and Affected person Views,” discovering that 69 p.c of sufferers with OSA are prepared to modify to a pill-form therapy. The survey was commissioned by Incannex.
Sulthiame reduces OSA severity (Sept. 10)
Sufferers taking sulthiame, a drug at present in use for epilepsy, skilled a discount of their signs of OSA, based on outcomes of a scientific trial. Sulthiame inhibits the enzyme carbonic anhydrase and stimulates the higher airway muscle groups.
Apnimed pronounces early completion of enrollment in part 3 SynAIRgy research (Sept. 19)
Apnimed introduced the early completion of enrollment in its SynAIRgy Section 3 Examine, which is able to study the efficacy and security of AD109 (aroxybutynin / atomoxetine) in comparison with placebo at six months in adults residing with OSA.
Avadel pronounces Lumryz scientific trial outcomes (Sept. 25)
Avadel Prescribed drugs introduced publication of scientific trial outcomes exhibiting important enhancements in sufferers with narcolepsy taking Lumryz (sodium oxybate) in contrast with placebo, no matter concomitant use of alerting brokers.
FDA approves Lumryz for pediatric narcolepsy (Oct. 17)
Avadel Prescribed drugs introduced the FDA has permitted its supplemental new drug utility for Lumryz (sodium oxybate) for the therapy of cataplexy or extreme daytime sleepiness in sufferers 7 years of age and older with narcolepsy.
Jazz presents new Xywav trial information (Oct. 31)
At Psych Congress 2024, Jazz Prescribed drugs offered the top-line outcomes of the Section 4 DUET trial, evaluating the effectiveness of low-sodium oxybate on key sleep outcomes in adults with narcolepsy or idiopathic hypersomnia.
Alkermes presents information on ALKS 2680 (Nov. 7)
Alkermes offered security and efficacy information on ALKS 2680, a novel, investigational oral drugs in growth as a as soon as every day therapy for narcolepsy and idiopathic hypersomnia, at two scientific conferences this fall.
Combo drug remedy for sleep apnea (Nov. 16)
A research within the Annals of the ATS experiences short-term use of twin medicine acetazolamide + eszopiclone considerably improved OSA severity. Including venlafaxine didn’t typically enhance OSA severity however could also be useful for some sufferers.
Solriamfetol improves cognitive operate (Nov. 16)
A randomized part 4 scientific trial printed in CHEST discovered that solriamfetol can enhance goal and subjective measures of cognitive operate in sufferers with cognitive impairment related to OSA and extreme daytime sleepiness.
AXS-12 demonstrates cataplexy enchancment (Nov. 26)
Axsome Therapeutics introduced that AXS-12 (reboxetine) achieved the first endpoint within the ENCORE part 3 trial in narcolepsy, exhibiting a statistically important enchancment in cataplexy assault frequency in comparison with placebo.
