FDA Drug Approvals, Psychiatry  — 2022 Midyear Review

August 24, 2022

Daridorexant (Quviviq)

Daridorexant is a dual orexin receptor antagonist. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive. Daridorexant is indicated for adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Approval was based on two phase 3 multicenter, randomized, double-blind, placebo-controlled trials. Participants were randomized 1:1:1 to receive daridorexant 50 mg, daridorexant 25 mg, or placebo (study 1; n = 930), or daridorexant 25 mg, daridorexant 10 mg, or placebo (study 2; n = 307) every evening for 3 months. The primary endpoints were change from baseline in wake time after sleep onset (WASO) and latency to persistent sleep (LPS), measured by polysomnography, at months 1 and 3. In study 1, the daridorexant 25-mg and 50-mg doses showed a statistically significant improvement in all endpoints, compared to placebo, at both month 1 and month 3 (P<0.0001). In study 2, the daridorexant 25-mg dose showed statistically significant improvement in WASO at month 1 (P=0.0001) and month 3 (P=0.0028) compared to placebo. Lancet Neurol. 2022 Feb;21(2):125-139

Other psychiatry approvals

Xelstrym (dextroamphetamine transdermal) – New transdermal patch indicated for treatment of attention deficit hyperactivity disorder (ADHD) in adults and children aged 6 years and older. 

Nalmefene – Opioid antagonist reintroduced to the US market for management of known or suspected opioid overdose.

Qelbree (viloxazine) – Indication for ADHD expanded to include adults.

Igalmi (dexmedetomidine) – New buccal dosage form and indication for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder.

Zulresso (brexanolone) – Indication for postpartum depression expanded to include adolescents aged 15 years and older. 


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