Endo Int'l (ENDP) Announces Statistically Significant Data from Xiaflex Phase 2 in Dupuytren's Disease Nodules

September 30, 2016 7:31 AM EDT

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Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (Nasdaq: ENDP), announced new data to be presented evaluating the safety and efficacy of XIAFLEX(collagenase clostridium histolyticum) (or CCH) injection under investigation for the treatment of palmar Dupuytren's disease nodules. The findings will be presented during a podium presentation on Saturday, October 1, 2016 at 10:40 a.m. CDT at the annual meeting of the American Society for Surgery of the Hand (ASSH) held from September 29 to October 1, 2016 in Austin, Texas.

In a Phase 2, randomized, double-blind, placebo-controlled, dose-ranging study, in 75 adult study participants with Dupuytren's disease and at least 1 nodule who received a single injection of CCH 0.40 mg or 0.60 mg, a statistically significant decrease was shown from baseline in the mean nodule surface area (P≤0.001), consistency score (P<0.001) and hardness score (P≤0.01) at week 8 versus study participants receiving placebo. The safety profile of those treated with CCH was generally well tolerated. Adverse events included extremity pain, axillary pain, injection site-related adverse events and pruritus. One adverse event was reported as severe (injection site pain with CCH 0.60 mg). No patients were discontinued from the study because of an adverse event.

The majority of study participants receiving higher doses of CCH were satisfied with their treatment and outcomes – 88.9 percent of 18 study participants in the 0.40 mg CCH group and 83.3 percent of 18 study participants in the 0.60 mg CCH group were "very satisfied" or "quite satisfied" with treatment at week 8 compared to placebo. Similarly, the investigators' global assessment showed an improvement in study participants versus placebo.

"Currently, no treatment has been approved by the U.S. Food and Drug Administration (FDA) for palmar nodules associated with Dupuytren's disease, although many nodules may be a pre-cursor to full Dupuytren's contracture," said Bronier Costas, M.D., orthopedic surgeon at The Hand and Upper Extremity Center of Georgia and the lead study investigator. "These study findings could be an encouraging indicator that treatment with agents that disrupt collagen formation may help reduce nodule size and consistency, and merit further investigation."

In this eight-week, double-blind trial, palpable palmar nodules on 75 adults with Dupuytren's disease and at least 1 palmar nodule were selected for treatment. Study participants were randomized to receive CCH 0.25 mg (n=22), 0.40 mg, or 0.60 mg (n=18, respectively) and then allocated to active treatment (CCH) or placebo (n=16). A single injection into the selected nodule was performed on Day 1. Starting at Week 1, all study participants were instructed to massage the nodule twice daily until Week 4. Efficacy and safety assessments were conducted throughout the study. Investigator-reported nodular consistency and hardness were evaluated at Weeks 1, 4, and 8. Investigator-rated patient improvement (1 [very much improved] to 7 [very much worse]) and patient satisfaction (1 [very satisfied] to 5 [very dissatisfied]) were assessed at week 8.

"XIAFLEX® continues to be the only FDA-approved treatment of adult patients with Dupuytren's contracture with a palpable cord," said Sue Hall, Ph.D., Endo's Executive Vice President, Chief Scientific Officer and Global Head of Research & Development and Quality. "We are encouraged that these new data showed a beneficial effect for patients with Dupuytren's nodules and the potential for improvement in symptoms and discomfort. We continue to be excited by these data and other potential indications for XIAFLEX®."



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