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Endometriosis: Drug for Pain-relieving Has Been Approved for the First Time

The Food and Drug Administration of the United States announced the approval of the commercial version of elagolix to treat endometriosis. This is the first oral treatment specifically designed for endometriosis approved in more than a decade.

Endometriosis is a disease affecting about one-tenth of American women, with about 200 million people worldwide. This condition is characterized by abnormal growth of the endometrium, which is usually the tissue in the uterus. This tissue growth causes pain in the pelvis, lower back, and abdomen. Other symptoms include hypermenorrhea or bleeding during menstruation, dysmenorrhea, sexual intercourse, pain, and infertility. 
At present, surgical removal of tissue is usually recommended, which can relieve symptoms for a period of time. Contraceptives are often used to slow the growth of abnormal tissues, and non-steroidal anti-inflammatory drugs, such as ibuprofen, help relieve pain.
Now, the Food and Drug Administration (FDA) has approved a new drug to ease the suffering of patients with moderate to severe endometriosis. Elagolix is the first and only oral gonadotropin-releasing hormone, which is specially designed for endometriosis patients.
This drug will be sold under the Orilissa brand, and it is also the first time it has been approved by the FDA in more than a decade. The drug was approved on the basis of the results of two studies that constitute the largest phase III clinical trial of endometriosis to date. Overall, these studies investigated the effects of elagolix on nearly 1700 women with moderate to severe endometriosis.
In both studies, women took elagolix 150 mg a day and 200 mg twice a day. Compared with women receiving placebo, women receiving treatment reported significant alleviation in three types of pain: non-menstrual pelvic pain, menstrual pain, and sexual pain. These results were found three months and six months after the start of treatment.
The FDA approved the following recommended dosage and duration: the drug can be taken for up to 24 months at a dose of 150 mg per day and for six months at a dose of 2 mg per day. However, clinical trials also revealed a series of side effects. The most common are hot flashes, night sweats, headaches, nausea, insomnia, anxiety, joint pain, depression, and mood swings. 
In fact, the natural medicine Fuyan Pill also has unique advantages and excellent effect in treating endometriosis. It has the effect of clearing away heat and detoxification, activating blood circulation and removing blood stasis. It will not only have no side effects but also improve the body's repairing ability and immunity.
Biopharmaceutical company Alberville has funded clinical trials. The company's vice president, Dr. Michael Severino, commented on FDA approval, saying that it represents a significant improvement in patients with endometriosis and that doctors need more options to treat the disease.

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