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TRENTON, N. J. –
A new treatment for pain caused by endometriosis was approved Tuesday by US regulators.
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The current condition involves abnormal tissue growth of the uterus that can cause severe pain and sterility.
Drug maker Abbvie said that the Food and Drug Administration approved the drug, Orilissa, for pain during menstruation and intercourse and at other times. Abbvie says it's the first new pill for endometriosis in a decade.
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In tests, she significantly reduced menstrual pain in about 45% of women on a low dose and 75% on a high dose, compared to about 20% of women who received dummy pills. Pain reduction outside of menstruation was slightly lower.
The drug works by reducing the production of the hormone estrogen. This caused side effects in some participants, including hot flashes, headaches and thinning bones.
Orilissa will cost $ 845 every four weeks, without insurance
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It is estimated that one in ten women of childbearing age suffers from endometriosis. Treatment usually begins with over-the-counter pain relievers, opioid analgesics and birth control pills. Other options include hormonosuppressant drug injections, which have significant side effects, and surgery.
The new pill offers a more flexible dosage to lower estrogen levels, according to Dr. Hugh Taylor of Yale Hospital – New Haven. A consultant at AbbVie, he helped lead key studies from Orilissa.
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Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma
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