IDIA.SWIDIA.SW

IDIA.SW is focused on psychiatry, with its drug Daridorexant (Trade Name: Quviviq) approved for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. The FDA review for Quviviq (NDA214985) resulted in an Approval. In clinical trials, Daridorexant demonstrated statistically significant treatment effects for WASO at Month 1 and Month 3 for the 25-mg and 50-mg doses in Trials ID-078A301 and for the 25-mg dose in ID-078A302. Statistically significant treatment effects for sTST were observed for the 25 mg dose in Trial ID-078A302 and the 25 mg and 50 mg doses in Trial ID-078A301. The IDSIQ sleepiness domain showed a statistically significant treatment effect for the 50 mg dose in Trial ID-078A301. Safety findings included depressive symptoms in 1 to 2% of patients taking daridorexant, compared to less than 1% in patients taking placebo. Sleep paralysis and hypnogogic or hypnopompic hallucinations were reported in less than 1% of subjects treated with 50 mg and 25 mg, respectively.