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5 июля 2022
ENDP Endo (ENDP) Phase II Study for Frozen Shoulder Disappoints Mon, July 4, 2022, 6:43 PM Endo International plc ENDP has announced disappointing top-line results from its phase II study of collagenase clostridium histolyticum (CCH) in participants with adhesive capsulitis (AC) of the shoulder. The condition is commonly known as “frozen shoulder.” The phase II study enrolled 198 participants with unilateral idiopathic AC of the shoulder with restricted range of motion (ROM) and function in the affected shoulder. Participants were randomized equally to receive CCH or placebo administered by ultrasound-guided injection. Participants received up to three injections, separated by a minimum of 21 days. Participants completed standard home exercises and received physical therapy at designated time points during the study. The primary endpoint was the change from baseline in the adapted American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Form composite score for the affected shoulder at the day 95 visit. This adapted scale measures pain and function parameters of the shoulder. Secondary endpoints included measures of passive and active range of motion improvement (PROM and AROM, respectively). The study participants receiving up to three doses of CCH showed some improvement in the change from baseline in the adapted ASES Standardized Shoulder Form composite score for the affected shoulder at the day 95 visit. But, the difference compared to those study participants receiving placebo was not statistically significant. However, the safety profile was consistent with the known safety profile from other studies. Consequently, Endo will be reevaluating the path forward for CCH to treat adhesive capsulitis of the shoulder. In March 2021, Endo launched collagenase clostridium histolyticum-aaes under the brand name QWO for the treatment of moderate to severe cellulite in the buttocks of adult women. Endo has lost 86.7% in the year so far compared with the industry’s 29.6% decline.
22 ноября 2021
TCRR 5 ноября делал анализ по нашей унылой красавице на месячном графике, отработала с точностью в 99,9%
17 ноября 2021
TCRR немного усреднил)))