We are encouraged by the number of patients and families supported by our products and services. It motivates us to continue to seek ways to improve the patient and provider experience with these products and to deliver our therapies to more people who could benefit from them.
In collaboration with research physicians, we are conducting a large clinical trial that will add to the body of knowledge provided by the NICHD MFMU Network study of hydroxyprogesterone caproate (HPC) injection (Meis NEJM 2003), now available as FDA-approved Makena. This is the largest randomized controlled trial to date assessing the impact of progestogen therapy on reducing the risk of recurrent singleton preterm birth. In April 2018, AMAG completed enrollment of more than 1,700 women into the PROLONG study. These patients will need to complete their course of therapy, including a 28-day neonatal follow-up. Primary results are expected in early 2019.1,3