SEP-225441

SEP-225441 is a modified-release formulation of eszopiclone, a non-benzodiazepine GABA-A receptor agonist. Developed by Sumitomo Pharma America (formerly Sunovion and Sepracor), it was specifically designed for the treatment of Generalized Anxiety Disorder (GAD). While the immediate-release version of eszopiclone is widely marketed as Lunesta for the treatment of insomnia, SEP-225441 was intended to provide sustained therapeutic levels suitable for managing chronic anxiety symptoms throughout the day. However, in a Phase 2 randomized, double-blind, placebo-controlled trial involving 440 patients, the drug failed to meet its primary efficacy endpoint of significantly reducing GAD symptoms as measured by the Hamilton Anxiety Rating Scale (HAM-A). Consequently, development for GAD monotherapy was discontinued.

Other names

eszopiclone modified-releaseeszopiclone MR