Neurocrine Biosciences Announces Successful Elagolix PETAL Study in End...(id and significant pain reduction in end...),Health

Secondary endpoints for the PETAL study were evaluated to assess the improvement of endometriosis symptoms following treatment with elagolix. Improvement in endometriosis symptoms was documented using several different scales for endometriosis pain. The following were assessed before, during and after the six months of treatment:

-- Total Composite Pelvic Sign and Symptoms Score (CPSSS), a validated

0-15 scale that assesses five components of endometriosis pain

severity, each on a 0-3 scale.

-- Dysmenorrhea (pelvic pain during menstruation), a component of the

CPSSS; 0-3 scale (0=absence of pain, 1=mild pain, 2=moderate pain,

3=severe pain)

-- 98% of patients at baseline had moderate or severe dysmenorrhea.

-- Non-menstrual pelvic pain (pelvic pain outside of menstruation), a

component of the CPSSS; 0-3 scale (0=absence of pain, 1=mild pain,

2=moderate pain, 3=severe pain)

-- 97% of patients at baseline had moderate or severe non-menstrual

pelvic pain.

-- Responder Rate, percentage of patients who had a one point or greater

decrease in pain score.

-- Visual Analog Scale (VAS) to assess pelvic pain levels using daily

electronic diary.

Elagolix provided a clinically meaningful and statistically significant reduction in endometriosis pain from baseline as shown below. The magnitude of improvement is comparable to that demonstrated with the currently approved agents, leuprolide and DMPA.

Screening Elagolix

Baseline 150mg qd 75mg bid DMPA

CPSSS 9.1

Week 4 mean -3.9
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