Mar 30 2011
Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced that the Company expects results from the PREGNANT Study, a Phase III clinical trial evaluating PROCHIEVE® (progesterone gel), will be published in a respected peer-reviewed medical journal online next week, and in the journal's print edition thereafter. The Company will issue a press release at the time of the online publication.
Columbia and Watson Pharmaceuticals, Inc. (NYSE:WPI) reported in December 2010 that in this pivotal Phase III clinical trial, the administration of PROCHIEVE was associated with a statistically significant reduction in the rate of preterm birth in women with a short cervical length 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. The incidence and profile of adverse events in patients receiving PROCHIEVE was comparable to placebo, which was as expected given the product's documented safety history.