Xiaflex (collagenase clostridium histolyticum)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved December of 2013

Specific Treatments:

Peyronie's disease

Therapeutic Areas

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General Information

Xiaflex (collagenase clostridium histolyticum) is an injectable formulation of purified collagenase, an enzyme that causes collagen to degrade within the connective tissue.

Xiaflex is specifically indicated 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.

Xiaflex is supplied as a powder for reconstitution into a solution for intralesional injection. The recommended treatment is a follows: Inject 0.58 mg Xiaflex into the target plaque once on each of two days, 1 to 3 days apart, according to the injection procedure. For each plaque causing the curvature deformity, up to four treatment cycles may be administered. Each treatment cycle may be repeated at approximately six-week intervals.

Clinical Results

FDA Approval
The FDA approval of Xiaflex for Peyronie's disease was based on two randomized, placebo controlled trials in 832 adult males with Peyronie's disease (Studies 1 and 2). All subjects had a penile curvature deformity of at lease 30 degrees in the stable phase of Peyronie's disease. The subjects received up to four treatment cycles of Xiaflex or placebo (weeks 0, 6, 12, 18) and were followed for weeks 24-52. In each treatment cycles, two injections of Xiaflex or placebo were administered 1 to 3 days apart. Treatment cycles were repeated at approximately 6 week intervals for up to three additional times, for a maximum of 8 injection procedures. A A penile modeling procedure was performed at the study site 1 to 3 days after the second injection of the cycle. Up to 4 total modeling procedures were preformed. The co-primary endpoints were the percent change from baseline to Week 52 in penile curvature deformity and the change from baseline to Week 52 in the Bother domain score of the PDQ. Study 1: baseline mean curvaturein the Xiaflex arm was 48.8 degrees and 49.0 degrees in the placebo arm. After treatment the Xiaflex arm had a -35.0% change while the placebo arm had a -17.8% change (p< 0.01). Study 2: baseline mean curvaturein the Xiaflex arm was 51.3% and 49.6% in the placebo arm. After treatment the Xiaflex arm had a -33.2% change while the placebo arm had a -21.8% change (p< 0.01). Xiaflex significantly reduced patient-reported bother associated with Peyronie’s disease compared with placebo (p<0.05).

Side Effects

Adverse effects assocated with the buse of Xiaflex for Peyronie's disease may include, but are not limited to, the following:

  • penile hematoma
  • penile swelling
  • penile pain

Mechanism of Action

Xiaflex (collagenase clostridium histolyticum) is an injectable formulation of purified collagenase, an enzyme that causes collagen to degrade within the connective tissue. Peyronie’s disease are caused by a collagen plaque. Injection of Xiaflex into a Peyronie’s plaque, which is comprised mostly of collagen, may result in enzymatic disruption of the plaque. Following this disruption of the plaque, penile curvature deformity and patient bother caused by Peyronie’s disease are reduced.

Additional Information

For additional information regarding Xiaflex or Peyronie's disease, please visit the Xiaflex web page.