Delta Pharm sponsoring methotrexate/misoprostol medical abortion Phase III trial in 1,500 women.
Executive Summary
DELTA PHARM WILL CONDUCT METHOTREXATE/MISOPROSTOL MEDICAL ABORTION STUDY in 1,500 women as an alternative to surgical abortion, the private New York City women's reproductive health products company announced Aug. 30. The Phase III study, which has not yet begun enrollment but does have an IND from FDA, will be conducted at 10-12 institutions nationwide that undertake a sufficient volume of surgical abortions to meet the patient population criterion. Delta hopes to file an NDA for the two-drug regimen for medical abortion in 1996.