Raphe Pharma (27)

FDA Approval of MYFEMBREE – A New Treatment for Men with Complete Androgen Insensitivity Syndrome

Complete androgen insensitivity syndrome (CAIS) is a rare genetic condition in which a man has normal or functioning testes but either no or limited function of the androgen receptor. As a result, the man has little or no ability to produce testosterone, the male sex hormone that drives secondary sexual characteristics such as hair growth and facial features. The lack of functioning androgen receptors also prevents the man from having any type of genital development. CAIS affects approximately 1 in every 15 million males, making it one of the most common inherited genetic conditions. Individuals with CAIS usually do not live past infancy due to failure to develop external genitalia. While current medical treatments exist for lower urinary tract symptoms related to incomplete androgen insensitivity syndrome, there is currently no cure for this disease.

Myovant Sciences and Pfizer Announce FDA Approval of MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis

Endometriosis is a common condition in which tissue similar to endometrial tissue is found outside of the uterus, most commonly on the ovaries, bowel, or other pelvic organs. In addition to being painful, endometriosis is associated with increased risk of certain types of cancers. The FDA approval of MYFEMBREE® as a treatment for moderate to severe chronic pelvic/endometriosous pain associated with endometriosis was based on a global Phase III clinical trial that included women with moderate to severe chronic pelvic/endometriosous pain associated with endometriosis. In the primary endpoint, MYFEMBREE® met statistical significance as an improvement in pain (decrease of at least 50% from baseline) compared to placebo over 24 weeks. MYFEMBREE® is a subcutaneous implant containing subdermal pellets that are designed to release oxytocin, a naturally-occurring hormone in the body that has been shown in several human studies to improve symptoms of chronic pelvic/endometriosous pain associated with endometriosis. MYFEMBREE® is the first treatment for endometriosis that targets the source of pelvic/endometriosous pain, providing a better treatment alternative for these women.

What is endometriosis?

Endometriosis is a common condition in which tissue similar to endometrial tissue is found outside of the uterus, most commonly on the ovaries, bowel, or other pelvic organs. In addition to being painful, endometriosis is associated with increased risk of certain types of cancers. Endometriosis is often difficult to diagnose due to its similar-appearing signs and symptoms (such as painful periods) with other conditions that are unrelated to endometriosis. These other conditions may, in some cases, be more difficult to diagnose than endometriosis. Typically, the diagnosis of endometriosis is made after confirmation of a finding on laparoscopy, such as endometriosis lesions on the ovaries, bowel, or pelvic/perineal areas.

How does Myovant Sciences’ MYFEMBREE® work?

MYFEMBREE® works by releasing oxytocin, a naturally-occurring hormone in the body that has been shown in several human studies to improve symptoms of chronic pelvic/endometriosous pain associated with endometriosis. MYFEMBREE® is the first treatment for endometriosis that targets the source of pelvic/endometriosous pain, providing a better treatment alternative for these women. MYFEMBREE® is designed to be implanted subdermally, releasing oxytocin over a period of 4 to 6 weeks. MYFEMBREE® is a subcutaneous implant containing subdermal pellets that are designed to release oxytocin, a naturally-occurring hormone in the body that has been shown in several human studies to improve symptoms of chronic pelvic/endometriosous pain associated with endometriosis. MYFEMBREE® is the first treatment for endometriosis that targets the source of pelvic/endometriosous pain, providing a better treatment alternative for these women. MYFEMBREE® is designed to be implanted subdermally, releasing oxytocin over a period of 4 to 6 weeks. MYFEMBREE® is a subcutaneous implant containing subdermal pellets that are designed to release oxytocin, a naturally-occurring hormone in the body that has been shown in several human studies to improve symptoms of chronic pelvic/endometriosous pain associated with endometriosis. MYFEMBREE® is the first treatment for endometriosis that targets the source of pelvic/endometriosous pain, providing a better treatment alternative for these women. MYFEMBREE® is designed to be implanted subdermally, releasing oxytocin over a period of 4 to 6 weeks. MYFEMBREE® is a subcutaneous implant containing subdermal pellets that are designed to release oxytocin, a naturally-occurring hormone in the body that has been shown in several human studies to improve symptoms of chronic pelvic/endometriosous pain associated with endometriosis. MYFEMBREE® is the first treatment for endometriosis that targets the source of pelvic/endometriosous pain, providing a better treatment alternative for these women. MYFEMBREE® is designed to be implanted subdermally, releasing oxytocin over a period of 4 to 6 weeks.

Benefits of MYFEMBREE® in pain management

– MYFEMBREE® is a subcutaneous implant containing subdermal pellets that are designed to release oxytocin, a naturally-occurring hormone in the body that has been shown in several human studies to improve symptoms of chronic pelvic/endometriosous pain associated with endometriosis. MYFEMBREE® is the first treatment for endometriosis that targets the source of pelvic/endometriosous pain, providing a better treatment alternative for these women. MYFEMBREE® is designed to be implanted subdermally, releasing oxytocin over a period of 4 to 6 weeks. – MYFEMBREE® is a subcutaneous implant containing subdermal pellets that are designed to release oxytocin, a naturally-occurring hormone in the body that has been shown in several human studies to improve symptoms of chronic pelvic/endometriosous pain associated with endometriosis. MYFEMBREE® is the first treatment for endometriosis that targets the source of pelvic/endometriosous pain, providing a better treatment alternative for these women. MYFEMBREE® is designed to be implanted subdermally, releasing oxytocin over a period of 4 to 6 weeks. – MYFEMBREE® is a subcutaneous implant containing subdermal pellets that are designed to release oxytocin, a naturally-occurring hormone in the body that has been shown in several human studies to improve symptoms of chronic pelvic/endometriosous pain associated with endometriosis. MYFEMBREE® is the first treatment for endometriosis that targets the source of pelvic/endometriosous pain, providing a better treatment alternative for these women. MYFEMBREE® is designed to be implanted subdermally, releasing oxytocin over a period of 4 to 6 weeks. – MYFEMBREE® is a subcutaneous implant containing subdermal pellets that are designed to release oxytocin, a naturally-occurring hormone in the body that has been shown in several human studies to improve symptoms of chronic pelvic/endometriosous pain associated with endometriosis. MYFEMBREE® is the first treatment for endometriosis that targets the source of pelvic/endometriosous pain, providing a better treatment alternative for these women. MYFEMBREE® is designed to be implanted subdermally, releasing oxytocin over a period of 4 to 6 weeks. – MYFEMBREE® is a subcutaneous implant containing subdermal pellets that are designed to release oxytocin, a naturally-occurring hormone in the body that

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