Amag Pharma Makena data disappointing

AMAG Pharmaceuticals (NASDAQ:AMAG) is down 6% premarket on light volume in response to disappointing results from a Phase 3 clinical trial, PROLONG, evaluating Makena (hydroxyprogesterone caproate injection) for the prevention of preterm birth in women with histories of prior spontaneous singleton preterm deliveries.

The study failed to demonstrate a statistically significant treatment benefit from Makena compared to placebo. Specifically, the rate of preterm delivery in the Makena cohort was 11.0% compared to 11.5% for control (p=0.72). The percentages of patients who met the criteria for the pre-specified neonatal morbidity and mortality composite index were also comparable (5.4% for Makena vs. 5.2% for placebo, p=.84). The safety profiles were similar.

The company says it will conduct additional subgroup analyses (in an effort to find something positive). It plans to submit the data to the FDA and for publication.

The FDA approved the drug in February 2011 to reduce the risk of preterm birth in at-risk pregnant women.

https://seekingalpha.com/news/3441139-amag-pharma-6-percent-premarket-disappointing-makena-data