Ferring Pharmaceuticals recently gained FDA approval for Milprosa, a once-weekly progesterone vaginal ring for the luteal phase support in women undergoing Assisted Reproductive Technology (ART) treatment cycles.

According to GlobalData, US sales of the various progesterone options used for luteal phase support during ART cycles were estimated at $78M in 2019. By 2028 sales are expected to exceed $100M, with Milprosa capturing approximately one third of these sales.

In stimulated ART cycles, progesterone supplementation is required for luteal phase support in order to compensate for the luteal phase defect that is caused by the GnRH agonists and antagonists used in IVF protocols. However, an unmet needs remains for progesterone options with a more convenient route of administration.

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

Progesterone used in this setting is most commonly administered either through the Intramuscular (IM) or vaginal route; however, both options have disadvantages for the patient.

Lambrinos continues: “Intramuscular progesterone is the most popular form currently used by US reproductive endocrinologists, yet it involves daily injections that are difficult to administer and cause significant pain and discomfort at injection sites. For vaginal forms –such as suppositories or gels– some debate persists among physicians regarding their effectiveness 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 is 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 optionand 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.”