Endo Presents Data on the Use of a Standing MRI for the Evaluation of Cellulite at the American Society for Dermatologic Surgery (ASDS) Annual Meeting
DUBLIN, Oct. 24, 2019 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today announced that it will present data on the use of a standing MRI as compared to prone MRI for the evaluation of cellulite at the upcoming Annual Meeting of the American Society for Dermatologic Surgery (ASDS) in Chicago, IL. Endo will display two posters from October 24th until October 27th. The first poster will present a case study comparison of the use of a standing MRI versus a prone MRI for the evaluation of cellulite. The second poster will be an encore presentation of the Phase 3 data of collagenase clostridium histolyticum (CCH) for the investigational treatment of cellulite.
The first abstract poster will be titled "The First Reported Use of Standing MRI for the Evaluation of Cellulite: A Case Study Comparison of Standing vs. Standard (Prone) MRI." This case study was designed to compare the anatomy of collagen septae in a woman with cellulite using a standing MRI versus standard (prone) MRI, because cellulite is typically observed in an upright/standing position. Such comparison results showed a <10° difference between the angle of collagen septae orientation relative to the dermis in the standing and prone MRI. Septae orientation in the prone position was not perpendicular to the skin.
The second abstract poster, titled "Two Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trials of Collagenase Clostridium Histolyticum (CCH) for the Treatment of Cellulite," includes data previously presented at the 2019 Aesthetic Society meeting, on May 17, 2019. 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. Most adverse events observed in CCH-treated patients were transient, mild/moderate and injection-site related (e.g., bruising, pain, induration, pruritus, erythema, and discoloration).
"We are pleased that the data from these studies will be presented at the premier meeting for dermatologic surgeons," said Matthew Davis, M.D., R.Ph., Chief Medical Officer, Senior Vice President, Research and Development, Branded Pharmaceuticals at Endo Pharmaceuticals. "It is important that aesthetic healthcare providers have data on the most effective ways to evaluate the internal structure of cellulite. We believe our continued research will improve potential outcomes and patient satisfaction with cellulite treatments that target collagen septae."
Cellulite is a localized alteration in the contour of the skin that has been reported in 85 to 98 percent of post-pubertal females and affects women of all races and ethnicities.1,2 The primary cause of the condition is a thickening of the collagen septae that attach the skin to the underlying fascia layers with additional contributing protrusions of subcutaneous fat. The septae tether the skin, which causes the surface dimpling characteristic of cellulite.2,3 Cellulite clinically presents on the buttocks, thighs, lower abdomen and arms.
It is known that cellulite is different from generalized obesity. In generalized obesity, adipocytes undergo hypertrophy and hyperplasia that are not limited to the pelvis, thighs, and abdomen.4 In areas of cellulite, characteristic large, metabolically stable adipocytes have physiologic and biochemical properties that differ from adipose tissue located elsewhere. Weight gain makes cellulite more noticeable, but it may be present even in thin subjects. Genetics may also play a role, since cellulite tends to run in families.
Despite multiple therapeutic approaches for the attempted treatment of patients with cellulite, there are currently no FDA-approved injectable treatments on the market.5
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Company Codes: NASDAQ-NMS:ENDP