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The clinical trials evaluated 2 doses of ORILISSA: 150 mg taken once-daily and 200 mg taken twice-daily (for a total of 400 mg) compared to placebo. Both doses worked to reduce 2 common types of endo pain - painful periods and pelvic pain in between periods. Additionally, ORILISSA 200 mg reduced pain with sex.* It is important to remember that ORILISSA works differently from one woman to the next.
*Only the 200 mg twice daily dose was proven to work for pain with sex.
Largest clinical trial program to date
ages 18 to 49 with moderate to severe endometriosis pain
compared to placebo
1. Painful periods
2. Pelvic pain in between periods
3. Pain with sex*
These women also did not have an increased use of painkillers† compared to when they began the studies.
In Study 1, a higher percentage of women reported a reduction in pelvic pain in between periods with ORILISSA 150 mg and ORILISSA 200 mg than women taking placebo. Similar results were seen in Study 2.
These women also did not have an increased use of painkillers† compared to when they began the studies.
†Painkillers used in the clinical trials were opioids (hydrocodone with acetaminophen) or naproxen.
Prescription and over-the-counter painkillers can be used to manage endometriosis pain and some inflammation. Some are taken as needed, rather than daily. Because ORILISSA works throughout your menstrual cycle, it is not a medication you take only as needed. It’s important to take ORILISSA every day, exactly as your doctor prescribed, even if you’re feeling better.
In the ORILISSA clinical trials, researchers compared the effects of ORILISSA against a placebo. This is how researchers could determine whether any benefits or side effects that occurred were caused by ORILISSA.
