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Executive Summary

UPJOHN's PREPIDIL GEL FOR CERVICAL RIPENING WILL BE AVAILABLE IN FEBRUARY following approval by FDA on Dec. 9. Prepidil Gel (dinoprostone 0.5 mg) is indicated for "ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction," approved labeling states. The NDA (19-617) for Prepidil Gel was submitted June 12, 1986 and resubmitted on Nov. 30, 1990. Upjohn also markets a 20 mg dinoprostone vaginal suppository, Prostin E2, which is indicated for intrauterine death, termination of pregnancy and benign hydatidiform moles. Dinoprostone is the naturally-occurring form of prostaglandin E[2] (PGE[2]). Labeling states that PGE[2] "administered endocervically produces effacement and softening by combined contraction-inducing and cervical- ripening properties. There is evidence," labeling adds, "to suggest that the changes that take place within the cervix are due to collagen degradation resulting from collagenase secretion as a response, at least in part, to PGE[2]." Upjohn said Dec. 10 that the drug "has been shown to significantly increase the incidence of successful initial labor inductions" and to "help reduce the time interval from induction to vaginal delivery." While cervical ripening normally occurs over a period of five to six weeks predelivery, the company noted that an estimated 5%-10% of U.S. births require cervical ripening assistance. In clinical trials of 1,731 women, Prepidil was "generally well tolerated," labeling states. Adverse reactions seen at an incidence above 1% included: uterine contractile abnormality (6.6%), gastrointestinal effects (5.7%), back pain (3.1%), warm feeling in the vagina (1.5%) and fever (1.4%) in the mother; and, in the fetus, heart rate abnormality (17%), including bradycardia and deceleration. Labeling warns that dinoprostone should be administered only in hospitals "that can provide immediate intensive care and acute surgical facilities." Prepidil Gel is contraindicated in some patients, including those women in whom "oxytocic drugs are generally contraindicated or where prolonged contractions of the uterus are considered inappropriate." If oxytocic drugs are used sequentially, labeling recommends a dosing interval of six to 12 hours. Contraindicated cases include a history of Cesarean section, major uterine surgery, difficult labor and/or traumatic delivery; fetal distress where delivery is not imminent; patients with ruptured membranes; and patients where vaginal delivery is not indicated, such as active genital herpes. The gel, packaged in a prefilled syringe with 10 mm and 12 mm shielded catheters for administration, will be available at a direct price of $75 per syringe, Upjohn said Dec. 10. The recommended dosing is one syringe. If a repeat dose is needed, labeling recommends an interval of six hours. The maximum recommended cumulative dose is 1.5 mg dinoprostone. Prepidil is the seventh NDA approval for Upjohn in 1992 and the third women's health care product. So far this year, the company also has received NDA approvals for Depo-Provera contraceptive injection, Cleocin vaginal cream, Vantin oral suspension, Glynase Prestabs and Gelfoam sterile powder.

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