Efficacy

Makena helps reduce the risk of recurrent preterm birth1

Makena reduced the rate of preterm birth vs placebo
makena efficacy chart

Compared to controls, treatment with Makena reduced the proportion of women who delivered preterm at <37 weeks. The proportions of women delivering at <35 weeks and <32 weeks also were lower among women treated with Makena. The upper bounds of the confidence intervals for the treatment difference at <35 weeks and <32 weeks were close to zero. Inclusion of zero in a confidence interval would indicate the treatment difference is not statistically significant. Compared to the other gestational ages evaluated, the number of preterm births at <32 weeks was limited.1

After adjusting for time in the study, 7.5% of Makena-treated subjects delivered prior to 25 weeks compared to 4.7% of control subjects.1

Results from a pivotal study conducted by the NIH. This double-blind, placebo-controlled trial evaluated 463 women with a history of spontaneous preterm delivery (singleton). Weekly injections of Makena 250 mg or weekly injections of an inert oil placebo were initiated between 16 weeks and 20 weeks of gestation and continued until week 37 of gestation or delivery.1