Phase III RELEASE studies of Xiaflex show improvements in cellulite.- Endo International.

Endo International announced positive results from two identical Phase III RELEASE studies of Xiaflex (collagenase clostridium histolyticum) (CCH) for the treatment of cellulite in the buttocks. Subjects receiving CCH showed highly statistically significant levels of improvement in the appearance of cellulite with treatment, as measured by the trial's primary endpoint (RELEASE-1, p=0.006 & RELEASE-2, p=0.002), which was at least a 2-level composite improvement in cellulite severity in the target buttock at Day 71 as compared to subjects receiving placebo. In addition, RELEASE-1 passed 8 out of 8 key secondary endpoints and RELEASE-2 passed 7 out of 8 key secondary endpoints. CCH was well-tolerated in the actively-treated subjects with most adverse events (AEs) being mild to moderate in severity and primarily limited to the local injection area. In RELEASE-1, 7.6 percent of subjects receiving CCH demonstrated a highly significant (p=0.006) improvement in the composite investigators' and patients' assessments of the appearance of cellulite, as measured by a two-level response in both the Clinician Reported- Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported- Photonumeric Cellulite Severity Scale (PR-PCSS) scores, for the target buttock at Day 71, compared to only 1.9 percent of placebo subjects.

In RELEASE-2, 5.6 percent of subjects receiving CCH demonstrated a highly significant (0.002) improvement in the composite investigators' and patients' assessments of the appearance of cellulite, as measured by a two-level response in both the CR-PCSS and PR-PCSS scores, for the target buttock at Day 71, compared to only 0.5 percent of placebo subjects. In addition, 37.1 percent of subjects in RELEASE-1, and 41.6 percent of subjects in RELEASE-2 receiving CCH demonstrated a highly significant 1-level response in the composite investigators' and patients' assessments of the appearance of cellulite, as measured by both the CR-PCSS and PR-PCSS scores, for the target buttock at Day 71, compared to only 17.8 percent and 11.2 percent of placebo subjects respectively.

Also 24.3 percent of subjects in RELEASE-1, and 21.0 percent of subjects in RELEASE-2 receiving CCH demonstrated a highly statistically significant 2-level improvement on the patients' assessment of the appearance of cellulite in the target buttock at Day 71, as measured by the PR-PCSS scores compared to only 12.2 percent and 5.8 percent of placebo subjects respectively. Finally, 54.3 percent of subjects in RELEASE-1, and 57.9 percent of subjects in RELEASE-2 receiving CCH demonstrated a highly statistically significant 1-level improvement on the patients' assessment of the appearance of cellulite in the target buttock at Day 71, as measured by the PR-PCSS scores compared to only 36.2 percent and 29.6 percent of placebo subjects respectively. CCH was well-tolerated in the Phase III studies by all dose groups with most adverse events (AEs) being mild to moderate and primarily limited to the local injection area.