Columbia/Watson preterm birth NDA

Columbia Laboratories has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for Prochieve (progesterone gel), a potential therapy to reduce the risk of preterm birth that it is developing in partnership with Watson Pharmaceuticals.

The topical vaginal product makes use of Columbia's bioadhesive drug-delivery technology, which is designed to provide controlled, sustained release. Watson and Columbia also partnered on Crinone, a progesterone gel approved for use in women undergoing fertility treatment. Columbia receives royalties on annual net sales of Crinone from Watson. 

The Prochieve NDA seeks approval for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. Currently, there are no widely accepted interventions to address the condition, according to the partners.

Columbia has requested a priority review for Prochieve, which if granted would mean that the FDA would aim to complete its review of the application in six months rather than the usual 10 months. Priority review status is reserved for investigational medicines that could offer significant advances beyond current treatments or where no adequate therapy exists.

The NDA submission includes data from two phase III clinical trials evaluating the use of Prochieve in reducing the risk of preterm birth in women, as well as supportive pharmacokinetic studies. One of the trials, known as the PREGNANT study, was published this month in the journal Ultrasound and Obstetrics and Gynecology.

The pivotal phase PREGNANT study showed that Prochieve significantly reduces the incidence of early preterm birth (before 33 weeks gestation) in women with a short cervix (length between 10 and 20mm as measured by transvaginal ultrasound) at mid-pregnancy, which was the trial's primary endpoint. The study also provided evidence of improvement in infant outcome.

The drug was associated with a 45 per cent reduction in the incidence of preterm birth before 33 weeks gestation, as well as with a significant reduction in the rate of preterm birth before 28 weeks gestation, according to the companies.