The US Food and Drug Administration has announced the approval of the commercial version of the drug elagolix for the treatment of endometriosis pain. Medical News Today reports that this is the first time in over a decade that an oral treatment specifically designed for endometriosis pain has been approved.
Endometriosis is characterised by an abnormal growth of endometrium, which is the tissue that normally lines the inside of the uterus. This tissue growth causes pain in the pelvis, lower back, and abdomen. Other symptoms include heavy periods or bleeding in-between periods, extremely painful menstrual cramps, pain during intercourse, and infertility.
The report says there is currently no cure for the condition, but surgery is often recommended to remove the tissue, which relieves the symptoms for a while. Birth control pills are often prescribed to slow down the growth of abnormal tissue, and non-steroidal anti-inflammatory drugs such as ibuprofen help ease the pain.
Now, the FDA has approved a new drug to ease the pain of women living with moderate to severe endometriosis. Elagolix is "the first and only oral gonadotropin-releasing hormone (…) antagonist" designed specifically for endometriosis and will be marketed at the beginning of August this year under the brand name Orilissa.
The drug was approved based on the results of two studies that formed the largest phase 3 clinical trial programme to have ever been conducted on endometriosis. In total, the studies examined the effects of elagolix on almost 1,700 women who had moderate to severe endometriosis pain.
In the two studies, the women were administered either 150 milligrams of elagolix once daily or 200 milligrams twice daily. Compared with the women who received placebo, those who received the treatment reported a significant reduction in three types of pain: non-menstrual pelvic pain, menstrual pelvic pain, and pain during intercourse.
These results were noted at 3 months and 6 months from the beginning of the treatment.
The FDA approved the following recommended dosage and duration of use: the drug can be taken for up to 24 months in a dosage of 150 milligrams per day, or up to 6 months if the dose is 200 milligrams twice per day.
However, the clinical trials also revealed a range of side effects. The most common ones were hot flashes, night sweats, headache, nausea, trouble sleeping, anxiety, joint pain, depression, and mood swings.
The bio-pharmaceutical company AbbVie funded the clinical trials. The report says Dr Michael Severino, the vice president of the company, commented on the FDA approval, saying that it "represents a significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease."
First study author Dr Hugh S Taylor – the chair of the department of obstetrics, gynaecology and reproductive sciences at the Yale School of Medicine, said: "Endometriosis is often characterised by chronic pelvic pain that can impact women's daily activities."
[link url="https://www.medicalnewstoday.com/articles/322611.php"]Medical News Today report[/link]
[link url="https://clinicaltrials.gov/ct2/show/NCT01620528?term=NCT01620528&rank=1"]Study details[/link]