Shot of a young woman suffering from stomach cramps in her bedroom
Uterine fibroids are growths made up of muscle and fibrous tissue that develop in or around the womb (uterus). They’re almost always non-cancerous and are sometimes known as uterine myomas or leiomyomas. Many people who have uterine fibroids aren’t aware of them because they often don’t have symptoms. However, some people experience heavy and painful periods because of them. This can be incredibly uncomfortable and difficult to manage. However, the FDA has approved the first non-surgical, oral medication option for the management of heavy menstrual bleeding due to uterine fibroids in premenopausal women.
AbbVie and Neurocrine Biosciences, Inc announced that the Food and Drug Administration (FDA) approved ORIAHNN with a treatment duration of up to two years. It’s an oral medication that is advertised to help people manage heavy menstrual bleeding associated with uterine fibroids. It’s a combination of elagolix and E2/NETA (estradiol/norethindrone acetate) to help achieve a balance between the reduction of heavy bleeding and associated hypoestrogenic side effects, which can include hot flashes, bone loss and headaches. Heavy and painful periods don’t just take a mental and physical toll on you, it can also make going about your day to day life incredibly difficult.
The results of the two, randomized Phase three clinical trials for ORIAHNN, published in The New England Journal of Medicine, found that seven out of 10 women no longer experienced heavy menstrual bleeding versus one out of 10 women on the placebo. Researchers also found that ORIAHNN reduces heavy menstrual bleeding due to uterine fibroids by 50% within the first month of use.
Studies have found that uterine fibroids are the most common type of benign tumor in women of reproductive age with 70% of Caucasian women and up to 80% of African American women being affected by them by age 50. One in three people who have uterine fibroids also experience side effects, including painful and heavy periods, lower back pain and pain or discomfort during sex.
If they aren’t causing symptoms fibroids can often be left and may shrink and disappear without treatment, particularly after the menopause. People with mild symptoms may opt to use gonadotropin-releasing hormone agonists to shrink the fibroids. However, these only remain effective for the period that you take the medication. In some cases, surgery is required to treat them.
“There’s the documented potential for psychological burden among women suffering from symptomatic uterine fibroids. Studies show that uterine fibroid-associated symptoms can affect women’s work, family and social activities,” says Charlotte Owens, M.D., Medical Director at AbbVie, “With the FDA’s approval, this therapy provides an important new option for the millions of people living with uterine fibroids who, for the first time, have a non-surgical, oral treatment option that is specifically approved treat their heavy menstrual bleeding.”
ORIAHNN is expected to be available in the U.S. by the end of June 2020 and is a prescription medicine so you should speak to your doctor if you’re considering taking it. You should take it twice daily, in the morning and evening, at approximately the same time each day with or without food and for up to two years. It shouldn’t be taken for longer than this due to possible side effects which include decreased bone mineral density, blood clots, irregular periods, fatigue and hot flashes.
Uterine fibroids affect so many people and the symptoms can be painful and cause serious disruption to everyday life. As the FDA has approved ORIAHNN it may be an option to help manage heavy menstrual bleeding due to uterine fibroids in premenopausal women.