You may have seen news articles and press releases flying around the Internet since yesterday regarding a new drug released to manage Endometriosis pain. I wanted to share this with you because, although I’ve no intention of taking the drug myself, I know that it may help women who suffer. And it may help better educate you on your decision.
I’ve been following it for a while and you can read my thoughts about AbbVie’s SpeakEndo commercials and website, as well as their expedited application for FDA approval, and the track records of other drugs that have done the same. And according to Business Insider, Orilissa may cost approximately $850 per month, or roughly $10,000 per year for prescriptions (I’m assuming those figures are calculated without health insurance). Orilissa is estimated to hit markets for prescriptions in August of this year.
So, here you go:
On July 23, 2018, the Food & Drug Administration approved AbbVie’s new drug to treat Endometriosis pain. You may have seen it referred to as Elagolix, but it has been officially named Orilissa. It is an oral GnRH antagonist.
Please do your own thorough research before talking to your physician.
In the Resources section below is a link to the FDA’s drug fact sheet, which includes a .pdf of the pamphlet that should come with the drug. Read it. Review the clinical trials. And decide for yourself. You can read the .pdf which I have downloaded, or by accessing the FDA’s site and downloading it for yourself.
It appears it has limited allowable dosing (6 months to 2 years), may cause liver issues, may cause bone loss, may cause depression and suicidal thoughts, and may interact with hormonal birth control. Some adverse reactions during clinical trials included appendicitis, abdominal pain, back pain, hot flashes, night sweats, nausea, decreased bone mass density, headache, insomnia, mood swings, depression, lack of a period, anxiety, joint pain, decreased libido, diarrhea, weight gain, dizziness, constipation, and irritability.
One participant in the clinical trials committed suicide two days after she stopped treating with the pill. She was 44 years old, had treated for one month, and had no medical history or life stressors that would have been indicative of suicidal thoughts.
Where did I get all this info? The FDA drug pamphlet.
Don’t trust me, read it for yourself.
Weigh the pros and cons.
And talk to your doctor.
A February 2019 study showed that women in Phase 3 Trials of Elagolix had improved period pain and non-period pelvic pain than those who were given the placebo pill. It stated that most adverse events were mild to moderate, but there was a risk of bone loss among patients.
And a June 2019 study showed that women in a 6-month clinical trial that were given Orilissa were at work 2-4 hours longer per week than women who were given the placebo, improving their attendance.
An August 2019 study funded by Abbvie was conducted to see if Elagolix could help reduced Endometriosis-induced fatigue. There were 860 women in the study, some of whom received a placebo. Both doses (150mg and 200mg) of Elagolix were tested. It was found that the participants who were given Elagolix had reduced levels of fatigue after taking it for six months. To those who stated they also had reduction in painful periods, pelvic pain, and pain with sex, their fatigue levels dropped even further. There have been studies that chronic pain, inflammation, stress, and depression can all affect fatigue and sleep patterns. So any reduction in those may help with symptoms of fatigue.
An October 2019 study written by Dr. Brian Ford of the Naval Hospital at Camp Pendleton shared a few warnings about Orilissa: Orilissa may decrease the effectiveness of some oral contraceptives, so non-hormonal contraception to avoid pregnancy while on Orilissa. The most common side effects that forced participants to drop out of the clinical trials were hot flashes and night sweats. There’s a risk of decreased bone density. Mood changes, depression, and/or suicidal thoughts may occur. The way the body metabolizes certain medications may be altered because of the way Orilissa affects liver enzymes. Other side effects reported in the trials were an absence of a period, headaches, and insomnia. Compared to the placebo group, after 3 months of trials, 46% of women taking the 150mg of Orilissa and 72% of those taking the higher 250mg dose had improved pain menstrual pain while on the drug. Dr. Ford stated that 28-day supply of Orilissa costs approximately $870. Due to the expensive nature of the drug, as well as the adverse side effects similar to other drugs (such as Lupron Depot), Dr. Ford recommends that ” Elagolix should be reserved for women who do not benefit from nonsteroidal anti-inflammatory drugs or hormonal therapy. ” Just a few thoughts to chew over and discuss with your physician…
A July 2020 study funded by Abbvie states that the “the lowest effective dose should be administered taking into account the treatment objections in conjunction with safety and coexisting conditions…” It may take some figurin’ out to find the right dose for you and your body, but start small. Another July 2020 Abbvie-funded study concluded that no Elagolix dosage changes were recommended if the patient was also taking add-back (norethindrone acetate) with Elagolix to help with some side effects.
In August of 2020, Abbvie funded a study to estimate how Elagolix may effect bone loss for post-menopausal women and lead to risk fractures. Due to its estrogen-reducing properties, there’s a risk in bone mineral density (BMD) loss. Having a lower BMD may lead to a greater risk of fractures and osteoporosis. The study used data collected from Abbvie’s Phase III trials, as well as BMD dadta from the National Health and Nutrition Examination Survey gathered from 2005-2010. Tricky math I don’t understand, but the study estimates that the risk of BMD loss, leading to fractures and osteoporosis later in life, is “minimal.” Is it a risk you’d like to take? That’s fine…just be informed.
Dr. Sanjay Agarwal of San Diego co-authored a February 2021 study wherein data from two clinical trials was analyzed to see if there was any difference in pelvic pain and menstrual bleeding for patients on Elagolix. The results point toward patients on Elagolix for three to six months reported less painful periods. Pelvic pain while not on their periods were also reportedly reduced. However, it also states, “Additionally, women in the placebo-treated group also reported a decrease in pain during both bleeding and non-bleeding days. It can be suggested that women would be more likely to report pain if bleeding occurs; therefore, given that women in the placebo group are reporting less pain during bleeding, we can infer that the reduction of pain seen in the elagolix treatment groups compared with the placebo group during bleeding is more remarkable.” In other words, the way I read it, participants reported less painful periods and pelvic pain EVEN ON THE PLACEBO…am I reading that wrong? But the study concludes that there was a greater reduction of pain all-around for patients who received Elagolix. Oh, and this study was paid for by Abbvie (the manufacture of Elagolix) and published in the Journal of Pain Research.
We are our best advocate. Do what you feel is best for you. But, please, do it informed and do it safely.
Knowing how poorly my body handled Lupron Depot (another AbbVie product that is incredibly similar), and how I became so severely depressed and suicidal on it, I will never again subject my body to something similar. It did nothing in the long-term to stem my Endometriosis. And was an incredibly difficult journey while on Lupron, as well as a long while before my body cleared itself of any side effects. That is why I choose not to take Orilissa. The decision is an individual one. Never again. But, again, I will never tell you not to try something; it may very well help you cope with your symptoms. Understand, though, that it is a band-aid. It will mask your symptoms; not clear your body of Endometriosis. I learned that one the hard way…
If you do your research and make a well-informed decision to start (or not start) Orilissa, I wish you all the best of luck and health. There are no judgments here. Only well-wishes. AND if you would like to leave a comment below with how Orilissa affected you, please do so! We can only be here to teach one another.
And, if you wish to see a quick snapshot of the participants and findings of the two clinical trials, please visit this FDA page.
**Updated March 26, 2021**
AbbVie – (July 24, 2018; Press Release) AbbVie Receives US FDA Approval of Orilissa (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis
American Family Physician (Oct. 15, 2019; Article) Elagolix (Orilissa) for Endometriosis Pain
American Society for Clinical Pharmacology & Therapeutics (July 2020; Article) Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women with Endometriosis-Associated Pain: An Application of Markov Model
Business Insider (July 24, 2018; Article) A New Treatment for a Condition that Can Feel Like Tiny People Skating on Razor Blades in Your Stomach and Affects an Estimated 200 Million Women Just Got Approved
Clinical Pharmacokinetics (Juyl 2020; Article) Drug Interaction Studies of Elagolix ith Oral and Transdermal Low-Dose Hormonal Add-Back Therapy
Drugs & Therapy Perspective (Feb. 2019; Abstract) Elagolix in Endometriosis-Related Pain: a Profile of its Use and Approved in the USA
Fertility & Sterility (June 2019; Abstract) Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials
Fertility & Sterility (August 2019; Abstract) Impact of Elagolix Treatment on Fatigue Experienced by Women with Moderate to Severe Pain Associated with Endometriosis
Journal of Bone & Mineral Research (Aug. 2020; Abstract and Article) Estimating the Effect of Elagolix Treatment for Endometriosis on Post-Menopausal Bone Outcomes: a Model Bridging Registrational Phase III Trials to an Older Real-World Population
Journal of Women’s Health (2020; Article) A Clinician’s Guide to the Treatment of Endometriosis with Elagolix
US Food & Drug Administration – Drug Database: Orilissa
~ Again, I am a layman. I do not hold any college degrees, nor mastery of knowledge. Please take what I say with a grain of salt. If curious, do your own research 😉 Validate my writings. Or challenge them. And ALWAYS feel free to consult with your physician. Always. Yours ~ Lisa