Proven Results in Clinical Trials

PROVEN RESULTS IN CLINICAL TRIALS

ORILISSA was proven to reduce 3 TYPES OF ENDOMETRIOSIS PAIN


1.   Painful periods        

2. Pelvic pain in between periods

3. Pain with sex*


*There are 2 different doses of ORILISSA: 150 mg (taken once a day) or 200 mg (taken twice a day). Only the 200 mg dose was proven to work for pain with sex.


Studied in the largest endometriosis clinical trial program to date

Both doses of ORILISSA (150 mg taken once a day or 200 mg taken twice a day) were studied against placebo in two 6-month clinical trials that involved:


1686
WOMEN



AGES
18 TO 49



WITH MODERATE
TO SEVERE
ENDO PAIN






1. Proven to reduce painful periods

In Study 1, more women reported a reduction in painful periods on ORILISSA 150 mg or ORILISSA 200 mg than women on 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. Proven to reduce pelvic pain in between periods

In Study 1, more women reported a reduction in pelvic pain in between periods on ORILISSA 150 mg or ORILISSA 200 mg than women on 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. Proven to reduce pain with sex

In Study 1, women reported a greater reduction in pain with sex on ORILISSA 200 mg than women on placebo. Similar results were seen in Study 2.

Only the 200 mg twice daily dose was proven to work for pain with sex.

  • ORILISSA starts working in the body to lower estrogen after about 24 hours; however, pain relief will take longer.
  • It may take 3 months to experience the full benefits of endo pain relief.

ORILISSA is not a painkiller. Painkillers work either by blocking pain messages in the brain or by reducing inflammation (depending on the type of painkiller). ORILISSA was made specifically for endometriosis pain. It reduces what fuels endo pain—estrogen.

Also, some painkillers are taken as needed, rather than every day. ORILISSA must be taken every day. It is not a medication you take only as needed. It’s important to take ORILISSA 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.