AMAG Says Latest Trial Of Makena Fails To Meet Primary Endpoints; Stock Down

(RTTNews) - AMAG Pharmaceuticals Inc. (AMAG) announced results from PROLONG--Progestin's Role in Optimizing Neonatal Gestation, a randomized, double-blinded, placebo-controlled clinical trial evaluating Makena in patients with a history of a prior spontaneous singleton preterm delivery. The PROLONG trial was conducted as part of an approval commitment under the Food & Drug Administration's (FDA) "Subpart H" accelerated approval process.

The company noted that the PROLONG trial did not demonstrate a statistically significant difference between the treatment and placebo arms for the co-primary endpoints: the incidence of preterm delivery at less than 35 weeks (Makena treated group 11.0% vs. placebo 11.5%, p=.72) and the percentage of patients who met criteria for the pre-specified neonatal morbidity and mortality composite index (Makena treated group 5.4% vs 5.2%, p=.84).

The adverse event profile between the two arms was comparable. Adverse events of special interest, including miscarriage and stillbirth, were infrequent and similar between the treatment and placebo groups. The PROLONG trial enrolled approximately 1,700 pregnant women, over 75 percent of which were enrolled outside the U.S.

In Friday pre-market trade, AMAG is trading at $12.83, down $0.89 or 6.49%.