Endo International plc (NASDAQ: ENDP) said its Paladin Labs subsidiary today announced the launch of a new indication for XIAFLEX® (collagenase clostridium histolyticum), the first and only Health Canada-approved treatment for appropriate patients with Peyronie's Disease.
XIAFLEX®, distributed and promoted by Paladin Labs, is available nationwide in Canada.
XIAFLEX®, an in-office biologic, was approved by Health Canada in January 2018 for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
The Health Canada review and approval was based on the results of safety and efficacy data from the pivotal IMPRESS (The I nvestigation for M aximal P eyronie's R eduction E fficacy and S afety S tudies) trials, the Phase 3 double-blinded placebo-controlled studies that assessed XIAFLEX® for the treatment of Peyronie's disease.
Paladin Vice President Livio Di Francesco said, "We are pleased to announce the commercial availability of XIAFLEX® in Canada for its new indication. As the only Health Canada-approved Peyronie's disease treatment, XIAFLEX ® is available to address a critical unmet need for men living with this distressing and sometimes painful condition.
"The launch of the new indication for XIAFLEX ® builds on Paladin's legacy of leadership in Men's Healthcare and exemplifies our focus on enhancing therapeutic options for patients and healthcare providers in this arena. It also demonstrates our capacity and commitment to successfully bring new treatments to market."
Endo stock began Monday up four cents to $5.54.
