Shares of specialty drug developer, Columbia Laboratories, Inc. (Nasdaq: CBRX) were up as much as 32 percent from Friday’s closing price in morning trading on Monday after the company announced positive results from a Phase 3 clinical trial of PROCHIEVE 8%, a gel developed by Columbia Laboratories and Watson Pharmaceuticals, Inc. (NYSE: WPI) to reduce the risk of preterm birth in women.
The administration of PROCHIEVE 8% vaginal progesterone gel was associated with a statistically significant reduction in the rate of preterm birth at less than or equal to 32 6/7 weeks gestation, the primary endpoint of the study, compared to placebo gel. There was also evidence of improvement in infant outcome. This study was conducted in collaboration with the Perinatology Research Branch (PRB) of the Division of Intramural Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH).
“The primary result of this trial shows that vaginal progesterone reduces the rate of spontaneous preterm birth,” said Dr. Roberto Romero, Chief of the Perinatology Research Branch of the NICHD/NIH.
Preterm birth affects 10 percent to 12 percent of all pregnancies in the United States, costing approximately $26 billion per year.
“If ultimately approved, the availability of PROCHIEVE 8% would represent a previously unavailable option in the physician’s arsenal of responses, which currently focuses on extending pregnancy where possible and addressing infant care following premature birth,” said Fred Wilkinson, Watson’s Executive Vice President, Global Brands in a statement.
Shares of Columbia Laboratories, Inc. have been up as much as 86 percent in the past three months.