FDA approves new endometriosis drug, bringing hope to nearly 200 million women across the globe
The United States Food and Drug Administration (FDA) has approved a new drug formulated to treat the intense pain caused by a condition called endometriosis, which affects women.
Endometriosis is a painful disorder in which the tissue which generally lines the inside of a woman's uterus, called the endometrium, begins growing outside of the organ. The unwanted tissue growth can also affect the fallopian tubes, ovaries, bowels, and bladder. In certain cases, the condition can affect other parts of the body too.
According to reports, nearly 200 million women across the world are believed to have endometriosis, which includes one in 10 women in the United States.
The FDA had approved the drug named Orilissa, which works by reducing the amount of estrogen produced in a person's body.
Women who suffer from the condition can experience pain in the pelvic region and lower back along with painful cramps and heavy periods. The disorder can also cause urinary and bowel problems, vomiting and nausea, chronic fatigue and pain during sex.
Not enough research has been conducted on the disorder, and it is not yet known what causes the condition. There is no available cure for the condition either; however, women who suffer from the disorder can manage their pain and infertility issues with drugs, hormone treatments, and surgery.
According to the Associated Press, the new drug, during clinical trials, showed positive results in reducing menstrual pain in nearly 45 percent of women who took a low dose and three-quarters of those given a high dose, in comparison to the control group.
The report added that some participants, during the trial, experienced certain side effects associated with the medication which included headaches, bone thinning, hot flashes, and trouble sleeping. Other participants also showed signs of anxiety, depression, mood changes and joint pain.
Orilissa, manufactured by AbbVie, is believed to be the first and only oral gonadotropic-releasing hormone developed for women with moderate to severe endometriosis pain. It is also believed to be the first new medication for endometriosis released in a decade.
Reports state that Orilissa will cost $845 every four weeks, without insurance.
According to Dr. Hugh Taylor of Yale-New Haven Hospital, the new drug provides a more flexible dosing in lowering estrogen levels. Dr. Taylor is a consultant to AbbVie and has assisted in leading important studies associated with the new drug.