An application for approval of a vaginal progesterone gel to prevent preterm birth has been rejected by the advisory panel of the Food and Drug Administration after it found that the gel was no more effective in preventing such births when compared with a placebo.
The panel said that while the gel, developed by Watson Pharmaceuticals and Columbia Laboratories, was safe to use, there was no evidence that it was more effective than using a placebo. The decision comes after the panel analyzed the 10-country study conducted by Columbia Laboratories which involved more than 465 pregnant women.
The study found that the gel was statistically significant in preventing preterm births at 33 weeks and was not effective when preventing births 27 weeks, 34 weeks, or 36 weeks.
The study was also criticized by the panel who said that the decision to club results from 10 different countries was wrong as the gel was more effective when applied by people from countries other than the United States.