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Endo Int'l To Showcase Late-Breaking Phase 3 CCH Data

Endo International plc (ENDP) said that it will present new data showing collagenase clostridium histolyticum or CCH significantly met the clinical endpoint of improved cellulite severity and appearance and was well tolerated in recent Phase 3 clinical trials.

The RELEASE-1 and RELEASE-2 Phase 3 studies, which were identically designed, randomized, double blinded and placebo-controlled, assessed the efficacy, safety and tolerability of CCH for the treatment of cellulite in women. A greater percentage of the 843 women treated during the studies (CCH vs. placebo: RELEASE 1, n=210 vs n=213; RELEASE-2, n=214 vs n=206) met the primary endpoint of response with CCH versus placebo in both the RELEASE-1 (P=0.006) and RELEASE-2 (P=0.002) studies.

In addition, statistically significant improvements with CCH versus placebo were observed for 8 of 8 (RELEASE-1) and 7 of 8 (RELEASE-2) secondary endpoints. Other patient-centric endpoints were also evaluated, including improvement in the Subject Global Aesthetic Improvement Scale (S-GAIS), a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the subject.

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