Treatment with pitolisant, a potent and highly selective H3-receptor antagonist/inverse agonist, reduces excessive daytime sleepiness and cataplexy in patients with narcolepsy.
Wakix is a selective H3 receptor antagonist/inverse agonist and the first treatment for narcolepsy that is not scheduled as a controlled substance.
The Drug Enforcement Agency (DEA) has designated Sunosi (solriamfetol; Jazz Pharmaceuticals) a Schedule IV controlled substance.
The FDA has approved Sunosi to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or OSA.
Harmony Biosciences announced that the FDA has accepted for Priority Review the New Drug Application for pitolisant for the treatment of excessive daytime sleepiness and/or cataplexy in adults with narcolepsy.
Investigators sought to determine whether baclofen might be an effective treatment for excessive daytime sleepiness and sleep fragmentation in patients with narcolepsy.
Efficacy in the pediatric population with narcolepsy was demonstrated in the Phase 2/3 EXPRESS study (N=106) which included patients aged 7 to 17 years with narcolepsy with cataplexy.
The Company stated that they plan to begin a Phase 2 trial of AXS-12 before the end of 2018, with results anticipated for the first half of 2019.
Patients in the 2 highest dosing groups saw significant, sustained improvements over the 12-week study.
The FDA has accepted the New Drug Application for solriamfetol for the treatment of sleep disorders.
