JACKSONVILLE, Fla. – A new treatment for pain caused by endometriosis was approved Tuesday by U.S. regulators.
The common condition involves abnormal tissue growth from the uterus that can cause severe pain and infertility.
Drugmaker Abbvie said the Food and Drug Administration approved the drug, Orilissa, for pain during menstruation and intercourse and at other times. Abbvie said it's the first new pill for endometriosis in a decade.
In testing, it significantly reduced menstrual pain in about 45 percent of women given a low dose and 75 percent given a high dose, compared to about 20 percent of women given dummy pills. Reduction of pain outside menstruation was slightly lower.
The drug works by reducing production of the hormone estrogen. That caused side effects in some participants, including hot flashes, headaches and bone thinning.
The new pill provides more flexible dosing in lowering estrogen levels, according to Dr. Hugh Taylor, of Yale-New Haven Hospital. A consultant to AbbVie, he helped lead key studies of Orilissa.
An estimated 1 in 10 women of reproductive age has endometriosis. Dr. Sonnie Kim-Ashchi, an OB-GYN at St. Vincent's Medical Center, said many cases go undiagnosed.
"It takes about seven years to get the diagnosis because, a lot of times, doctors think all the pain is in their head -- so you're going from doctor to doctor," Kim-Ashchi said.
Women have a greater risk of developing endometriosis if they've never given birth, started their period at an early age, have short menstrual cycles or have higher levels of estrogen.
Kim-Ashchi advised women to see a doctor if they are experiencing chronic pelvic pain, severe menstrual cramping, intercourse pain and infertility.
Treatment usually begins with over-the-counter pain relievers, opioid painkillers and birth control pills. Other options include injections of hormone-suppressing drugs, which have significant side effects, and surgery.
Orilissa will cost $845 every four weeks, without insurance. It may be the most cost-effective treatment.
"Orilissa, if you have insurance, is a lot cheaper than other forms," Kim-Ashchi said. "The injectable medication does not have insurance coverage with many insurance companies. Orilissa is a little bit cheaper because you don't have to go to the doctor's office."
Orilissa could be available in pharmacies as soon as next month.