Please login to the form below

Not currently logged in
Email:
Password:

Columbia/Watson preterm birth NDA

Columbia Laboratories has submitted a new drug application to the US Food and Drug Administration for Prochieve, a potential therapy to reduce the risk of preterm birth that it is developing with Watson Pharmaceuticals

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.

27th April 2011

Share

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
KVA Digital

KVA is an award winning full-service digital communications & brand experience agency. Our healthcare expertise blends creative ‘outside-the-box’ thinking with...

Latest intelligence

Good design saves lives
Good design and creative thinking are essential if we are to improve on existing problems in new ways, which is why design and creativity within healthcare is vital. Health is...
Why you must understand the pricing of patient recruitment companies
Recruiting a diverse range of patients and engaging with them for your clinical trial isn’t an easy task, which means you might turn to patient recruitment companies, like us, who...
wearable health tech
A cultural shift in clinical research
Research organisations across the board are experimenting with new technologies...

Infographics