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news.Columbia Laboratories has said its progesterone drug failed to meet the goal of a phase III study and did not achieve any reduction in the incidence of preterm birth in women.
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In the study there was no difference in the reduction of preterm birth incidence in patients with a previous preterm birth earlier than 35 weeks and treated with progesterone versus placebo at any endpoint.
The incidence and profile of adverse events in patients receiving progesterone was similar to placebo. Columbia was testing progesterone in a gel form called Procheive.
Columbia Laboratories said it is conducting detailed analyses of the study data, and intends to report the results of this trial in more detail at appropriate scientific venues.
Columbia said that although disappointed by the results, it has managed its resources carefully so that it is in a strong position to build on its existing infertility business. The company pointed to the recent acquisition of the US marketing rights to Crinone progesterone gel and its phase II lidocaine candidate for the prevention and relief of dysmenorrheal.