Endometriosis: a new drug authorized in the United States

For the first time in 10 years, there is something new in the field of endometriosis. And this novelty occurs in the therapeutic field. In the United States, the Food and Drug Administration (FDA) has authorized the placing on the market of Orilissa®

This medicinal product contains elagolix as an active substance. Described as a "gonadotropin-releasing hormone antagonist", it notably reduces the production of the hormones involved in endometriosis, estrogen and progesterone.

This mechanism should make it possible to reduce the main symtoms severe pain during menstruation, but also during badual intercourse or at other times in the pelvis

Less pain

In clinical trials, conducted on 1,700 women, a positive impact was found on menstrual pain . 20% of women had their situation improved with placebo compared to 45% of those who received 150 mg once daily and 75% of those who received 200 mg twice daily [19659002] The results are a little more mixed for pelvic pain: taking Orilissa® only improves the feeling by 20% compared to placebo, and only at the highest doses.

The drug should be available in American pharmacies from August. Its cost will be high, according to Associated Press . Uninsured women will have to pay 845 dollars (about 724 euros) for four weeks of treatment

Heavy side effects

The effects, they will be quite heavy because of the hormonal action

• A low level of œ estrogen may cause a decrease in bone mineral density, which normally occurs with age and after menopause. Women on treatment will be more at risk of fracture . The prescription will be contraindicated to women already suffering from osteoporosis.
• Any pregnancy will be strongly discouraged during treatment because Orilissa® can promote early miscarriage, without being an effective method of contraception. In case of pregnancy already started, no prescription can be established.
• The active principle may increase the level of transaminases in the liver . Women with severe liver diseases will not be able to receive this medication.
• Significant side effects on mood have been observed in clinical trials. Patients who have previously had mood, depression, or suicidal thoughts can not receive treatment.