Clinical Trials

CLINICAL TRIALS
FOR ORILISSA

ORILISSA was proven to reduce 3 common types of endometriosis pain*

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 dose was proven to work for pain with sex. The ORILISSA 150 mg dose didn’t show a significant difference in reported pain with sex compared with placebo (a pill with no active medicine).

ORILISSA—studied in the largest endometriosis clinical trial program to date.

2 STUDIES

Largest clinical trial program to date

1686 WOMEN

ages 18 to 49 with moderate to severe endometriosis pain

2 DIFFERENT DOSES

compared to placebo



ORILISSA was proven to reduce 3 TYPES OF PAIN


1.   Painful periods        

 2.   Pelvic pain in between periods

3.   Pain with sex*




#1 Reduced painful periods

In study 1, a higher percentage of women reported a reduction in painful periods with ORILISSA 150 mg and ORILISSA 200 mg than women taking placebo. Similar results were seen in Study 2.

Percent of women who reported reduced period pain at month 3:


46% of women reported a reduction in period pain at month 3 with ORILISSA 150 mg once a day in clinical trials.
76% of women reported a reduction in period pain at month 3 with ORILISSA 200 mg twice a day in clinical trials.
20% of women reported a reduction in period pain at month 3 with placebo in ORILISSA clinical trials.

These women also did not have an increased use of painkillers compared to when they began the studies.



#2 Reduced pelvic pain in between periods

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.

Percent of women who reported reduced pelvic pain in between periods at month 3:


50% of women reported a reduction in pelvic pain between periods at month 3 with ORILISSA 150 mg once a day in clinical trials.
55% of women reported a reduction in pelvic pain between periods at month 3 with ORILISSA 200 mg twice a day in clinical trials.
36% of women reported a reduction in pelvic pain between periods at month 3 with placebo in ORILISSA clinical trials.

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.



#3 Reduced pain with sex*

In Study 1, women taking 200 mg of ORILISSA showed a greater reduction in pain with sex* from baseline than women taking placebo.  Similar results were seen in Study 2.

*Only the 200 mg dose was proven to work for pain with sex. The ORILISSA 150 mg dose didn’t show a significant difference in reported pain with sex compared with placebo (a pill with no active medicine).

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.