Columbia Laboratories has a rich heritage in pharmaceutical research and development that has helped place the company on the forefront of women's healthcare and drug delivery. Our products use the principles of bioadhesion to achieve controlled, sustained delivery of hormones and other compounds that are difficult to administer. Commercially available products using our drug delivery technologies include:
In December 2010, we reported positive top-line results from the PREGNANT study, a large, global Phase III clinical trial evaluating PROCHIEVE® 8% (progesterone gel) for the reduction in the risk of preterm birth in women with premature cervical shortening. The study was published in April 2011 in the Journal of Ultrasound in Obstetrics and Gynecology. Access Publication. In April 2011, we submitted a new drug application (NDA) to the FDA for PROCHIEVE for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy; the FDA accepted this NDA for filing. The Advisory Committee for Reproductive Health Drugs of the FDA reviewed this NDA on January 20, 2012. While panel members generally agreed that progesterone vaginal gel 8% is safe, the Committee stated that more information is needed to support approval. Columbia transferred the NDA to Watson Pharmaceuticals on February 10, 2012; Watson now has full rights and regulatory responsibility for all activities and sponsor obligations relating to this application. On February 24, 2012, Watson received a complete response letter from the FDA for the NDA. The complete response letter stated that the effect of treatment with progesterone vaginal gel 8% in reducing the risk of preterm birth in women with a short uterine cervical length at ≤ 32 6/7 weeks gestation (p=0.022) did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial. Although not part of the requirements communicated to the sponsor during pre-Phase III meetings, the FDA also raised the issue of robustness in efficacy in the U.S. sub-cohort as compared to the overall efficacy of the trial. In the complete response letter, FDA stated that additional clinical work would be required to support the approval. Watson has formally requested an end of review meeting with FDA to determine if a viable path forward can be established for this application.
We continue to explore new applications for our drug delivery systems. STRIANT® is a registered trademark of Actient Pharmaceuticals LLC. CRINONE® is a registered trademark of Watson Pharmaceuticals, Inc. Replens® and RepHresh® are registered trademarks of Lil' Drug Store Products, Inc.
