Regulators at the FDA issued a brutal review for Columbia Laboratories' ($CBRX) application for its progesterone vaginal gel to prevent preterm delivery, saying the developer didn't provide the data needed to make a case on efficacy. Staffers now want an upcoming expert panel to consider whether Columbia should go back to the drawing board and conduct more studies. And once investors got wind of the assessment, the developer's shares tumbled 54% in after-hours trading.
"The information and data in this application do not support the efficacy of progesterone gel compared with placebo in reducing the risk of preterm births before 33 completed weeks," regulators concluded. In the U.S., pregnant women who were given the gel experienced preterm birth in 16.8% of all the cases tracked, compared to 19.2% of the women taking a placebo. That's an improvement, but not a statistically significant figure.
"It does not appear that the applicant has identified a population of U.S. women who are likely to benefit from the use of progesterone gel to reduce their risk of preterm birth," noted FDA staffers. Watson Pharmaceuticals ($WPI), which is partnered on the treatment, saw its shares slide 5%.
For its part, a spokesperson for Columbia Labs told Bloomberg that the FDA was basing its conclusions on a narrow group of participants in the study, which was global. "It was designed as a global study," she said. "FDA agreed."
Columbia Labs has been angling to compete with KV's ($KV-A) Makena, a recently approved therapeutic that has been the subject of considerable controversy. Makena is an approved version of a drug regularly prepared by compounding pharmacists at a fraction of the cost.