FDA Approves New Endometriosis Treatment Drug
This pill, Orilissa (elagolix), was available from the end of summer 2018 in the USA.
Soon there will be another treatment option for women experiencing symptoms of endometriosis. In July 2018!the U.S. Food and Drug Administration (FDA) announced their approval for AbbVie to market the drug Orilissa (elagolix) in the United States for use in treating pain caused by endometriosis. Taken as a daily pill, the drug was available in pharmacies early as August 2018.
The drug is made by AbbVie in partnership with Neurocrine Biosciences.
Endometriosis is a chronic oestrogen-dependent disease in which the uterine lining grows outside the uterus, usually on the ovaries, fallopian tubes, and surrounding tissue, causing severe pain, heavy bleeding, lesions, and sometimes issues with fertility. The American College of Obstetricians and Gynecologists (ACOG) estimates that endometriosis affects about 1 in 10 women of reproductive age in the United States.
A Welcome New Way to Help Ease Endometriosis Symptoms
There is currently no cure for endometriosis, so medical care has focused on pain reduction. AbbVie announced that elagolix is the first oral gonadotropin-releasing hormone (GnRH) antagonist developed for women with moderate to severe endometriosis pain. It is also the first new medical treatment option for endometriosis painbrought to market in a decade.
How the Drug May Work to Reduce Painful Symptoms
The pituitary gland releases gonadotropins, hormones that stimulate production of gonadal steroids such as oestrogen, both of which exacerbate symptoms of endometriosis and uterine fibroids. The GnRH-antagonist activity of elagolix reduces gonadotropin levels, which in turn suppresses estradiol, a type of oestrogen. This minimizes the pain associated with endometriosis and the spread of lesions.
Overall, the drug has been studied in more than 40 clinical trials with more than 3,000 subjects. Clinical phase 3 trials looked at approximately 1,700 women with moderate-to-severe endometriosis pain. Results showed that the drug significantly reduced the three types of pain caused by endometriosis: daily menstrual pelvic pain, nonmenstrual pelvic pain, and painful intercourse. Side effects were minimal.
Leena Nathan, MD, an assistant clinical professor at the department of ob-gyn at UCLA Health, is looking forward to seeing the drug come to market. She explains that it works by shutting down the pituitary hormone formation so there is less oestrogen circulating in the system. “It puts women into a premature menopause as long as the medication is taken. You reduce endometriosis symptoms, which is dependent on the hormonal cycle,” she says.
Potential Benefits of the Pill Delivery Method
Dr. Nathan adds that the treatment is in oral form instead of by injection, a bonus. “That makes it easily reversible. If the patient can’t tolerate the side effects, the effects wear off quickly after a day or two of stopping the drug. This is as opposed to a shot, which will last for one to three months. It’s also dose dependent, so you can get away with a lower dose, because we always worry about other issues such as bone loss and hot flashes with these kinds of medications.”
Helpful but Not a Cure: Some Experts Call for Cautious Optimism
Not every endometriosis specialist is ready to get on board just yet. Tamer Seckin, MD, a board-certified gynecologist and laparascopic surgeon in private practice at Seckin Endometriosis Center in New York City and the cofounder of the Endometriosis Foundation of America, says, “We have been fooled so many times until now. Elagolix might manage symptoms of endometriosis, but it’s not going to be the magic cure-all that everyone is expecting. It is not going to treat the actual disease. Gold standard treatment is early diagnosis and properly timed excisional removal of the disease. I am cautiously optimistic.”
Elagolix is also being studied for treatment of uterine fibroids, but it has not gained approval for that application yet.