Summary
The announcement by Bayer of submission of a novel estradiol based oral contraceptive to treat heavy menstrual bleeding addresses a growing trend among medical device makers and pharmaceutical companies: how to become involved in the growing market for medical and surgical treatments of heavy menstrual bleeding in order to lower the rate of hysterectomies performed for this reason.
Analysis
I believe Bayer is trying to become the first company to get FDA approval for a treatment that is currently considered "off label". Using oral contraceptives to treat heavy menses ( also termed menorrhagia in medical terms) has been applied for some time, though not with FDA approval. Physicians have been using different oral contraceptive pill (OCP) regimens to decrease menstrual flow for some time.
By acquiring FDA- approval for this indication, it will allow Bayer a clear marketing advantage in direct-to-consumer advertising as well as with acceptance by physicians. Also, as there is a growing trend for less invasive technologies to treat heavy menses, this allow s a clear advantage for the product as many women disdain even minimal office based procedures in favor of a medical therapy for this problem.
