Following the FDA approval of Ferring Pharmaceuticals’ once-weekly progesterone vaginal ring for luteal phase support in women undergoing assisted reproductive technology (ART) treatment cycles, the drug is expected to capture a third of the total US sales for progesterone options in this space, which will rise from $78m in 2019 to exceed $100m by 2028.

Kelly Lambrinos, Managing Pharma Analyst at GlobalData, comments: “An unmet need remains for progesterone options with a more convenient route of administration. Key Opinion Leaders (KOLs) interviewed by GlobalData have stressed the need for a patient-friendlier means of progesterone administration during ART cycles that are also highly efficacious in supporting implantation and pregnancy rates.”

Both intramuscular (IM) and vaginal routes have disadvantages for the patient. Intramuscular involves daily injections that are difficult to administer and causes significant pain and discomfort at injection sites, while some debate persists among physicians as to the effectiveness of vaginal suppositories and gels to create the necessary local tissue progesterone levels needed to support early pregnancy. Current vaginal options also require frequent administration, up to three times daily, compared to IM progesterone. With increased physician familiarity and confidence that it leads to comparable pregnancy rates versus current standard of care, Milprosa has the potential to partially address the need for options that are more convenient to the patient.

Lambrinos concludes: “While some experts may initially be concerned about pregnancy rates being maintained using a new vaginal option,and mayexercise a greater degree of caution before prescribing this option, ultimately as physician comfort increases, Milprosa has the potential to minimize the inconvenience and maximize the ease of progesterone administration. This would also simplify the overall ART process, which typically involves multiple, additional daily injections of hormonal preparations.”