Forest Labs' Cervidil Approved In USA

Forest Laboratories has received approval from the US Food and Drug Administration for its Cervidil (dinoprostone 10mg) Vaginal Insert and will launch the product in May. The drug is indicated for initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical reason for the induction of labor.

The prostaglandin E2 insert is designed for the controlled release of active component over around 12 hours, and is the only pessary device on the market with a retrieval device. The new product joins Upjohn's Prepidil (dinoprostone 0.5mg gel) on the market in the USA, and has the advantage of easy removal if uterine hyperstimulation occurs, according to Forest.

In controlled trials, the incidence of uterine hyperstimulation with fetal distress was reported in about 2% of Cervidil-treated women, uterine hyperstimulation without fetal distress occurred in 4.7%, and fetal distress without hyperstimulation was reported in 3.8%. Prepidil Gel is associated with an adverse reaction rate of less than 1%.