The Food and Drug Administration has recently approved a new commercial version of the drug called elagolix. This is a prescribed medicine for the treatment of endometriosis pain. First time in last 10 years, an oral treatment is specifically designed for easing the endometriosis pain has been approved by FDA.
As many of you already know that endometriosis is a disease that is highly prevalent all around the world. As per statistics, every 1 in 10 women in the USA is suffering from it. The affected women worldwide have reached 200 million which shows how common it is.
The endometrium is a condition in which the tissues of the inner uterus, called endometrium to start to grow abnormally. This induces a sharp pain in a pelvic area that also spreads to the lower back and lower abdomen. The characteristic symptoms of endometriosis include abnormal bleeding in between periods, painful periods, severe menstrual cramps and painful intercourse. Most of the times it leads to infertility in women.
Unfortunately, there is no permanent treatment for this condition until the date. Doctors often recommend a surgery in which they remove the tissue causing all the pain. However, it is not the permanent solution.
Sometimes the birth control pills are given as a part of the treatment. These pills often help by slowing down the growth of inner uterus tissues. The treatment also includes nonsteroidal anti-inflammatory drugs such as ibuprofen that help to ease the pain.
Now that the Food and Drug Administration (FDA) has approved a new medicine for pain relief while suffering from endometriosis, it will benefit thousands of women. This new drug is called Elagolix and it is the first and the only oral gonadotropin-releasing hormone antagonist that is specifically designed for endometriosis patients.
This drug will be available in the markets by the month of August. The brand name for this drug is Orilissa. It is one of the characteristic medicines for treating endometriosis. Additionally, it is approved by the FDA so finding it locally will not be a problem.
The drug is also proven by clinical trials. The approval is mainly based on the outcomes of the two studies that make this trial one of the largest clinical trials for any medicine. In total, 1700 women participated in the trials that examined the effects of elagolix on moderate to severe cases of endometriosis pain.
The standard dosage given to the women was 150mg once a day and 200mg twice a day on two groups. The results were compared with the placebo and those which received the drug showed a reduced occurrence of pain. It includes the pelvis, back, and belly pain. Additionally, the drug helped to reduce the pain during intercourse at a significant level.
The results were recorded at 3rd and 6th month of the drug monitoring. The FDA approved the dosage and duration both for this medicine. The recommended dosage is 150mg per day that can be used till 24 months. In severe cases 200mg twice a day is also suitable for a maximum of 6 months.
Not to forget, the clinical trial also revealed some of the side effects of it. Out of all, the most common was experiencing host flash, excessive sweating, headache, insomnia, anxiety, stress, depression and extreme mood swings.
These trials were funded by a biopharmaceutical company AbbVie. The vice president of the company Dr. Michael Severino says that approving this medicine by FDA is an advancement to help the women suffering from endometriosis. And not just this, it will also help the physicians by giving them more options for disease management.