The US Food and Drug Administration (FDA) today approved a first-in-class insomnia drug called suvorexant (Belsomra, Merck) (an Orexin receptor antagonist) after the manufacturer lowered the dosages to satisfy the agency's safety concerns.
Last July, Merck announced that the FDA had declined to approve suvorexant until the starting dose for most patients was 10 mg. The agency also said that proposed upper-limit doses of 30 mg for elderly patients and 40 mg for nonelderly patients were unsafe.
Fonts: Medscape
Nessun commento:
Posta un commento