The Food and Drug Administration (FDA) has approved a new medication to treat the pain caused by endometriosis, a little-understood condition that affects the uterus.
Endometriosis is a condition where the tissue that usually grows within the uterus—where a fetus develops during pregnancy—grows on the outside of the organ. This unwanted tissue growth can also affect the fallopian tubes, ovaries, bowels and bladder. In rare cases, it can affect other parts of the body.
Some 200 million women across the world are believed to have endometriosis, including one in 10 women in the U.S. Women with the condition can experience pain in the pelvic region and lower back, heavy periods and painful cramps. It can also cause bowel and urinary problems, nausea and vomiting, pain during sex and chronic fatigue. But for some women fertility problems are the first sign that they have the condition.
It is not yet known what causes the disorder, and there is currently no cure. But sufferers can manage their pain and infertility with drugs and hormone treatments. Some may need surgery to remove the excess tissue.
The FDA has approved Orilissa, which is used to manage moderate-to-severe pain associated with the condition caused during periods and sex. It works by reducing how much estrogen the body produces.
In clinical trials, the drug reduced menstrual pain in around 45 percent of women who took a low dose and three-quarters of those given a high dose, compared to the control group, Associated Press reported. Some participants experienced side effects including headaches, bone thinning, hot flashes, and trouble sleeping. Anxiety, depression, joint pain and mood changes were also noted in some study participants.
Manufactured by AbbVie, Orilissa is believed to be the first and only oral gonadotropic-releasing hormone developed for women with moderate to severe endometriosis pain. It is also said to be the first new drug for endometriosis released in a decade.
In the human body, the hypothalamus in the brain releases gonadotropic-producing hormones that help the testes and ovaries initiate and maintain their reproductive functions. The hormones play an important role in controlling when an egg is released during the menstrual cycle in women, and the production of sperm in men.
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