The HEALITE II™, an 830-nm light-emitting diode (LED) phototherapy system, received FDA 510k clearance and is now available for sale in the United States, following its successful global launch in Europe, the Middle East, Asia, and South America.
In the United States, the 830-nm HEALITE II is cleared for use in temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and temporarily increasing local blood circulation where applied.
HEALITE II is an LED phototherapy system that is globally available with 3 different wavelengths: 830 nm, 633 nm, and 415 nm. FDA clearance is limited to only the 830-nm wavelength at this time. It can be used as a stand-alone therapy or adjunctive to a wide variety of treatments, including aesthetic laser treatments. Each wavelength targets various different indications. Patients of all ages and skin types can benefit from the pain free, athermal, and easy-to-apply Healite treatments.
FDA and XIAFLEX
Auxilium Pharmaceuticals, Inc, has announced that the FDA has accepted for filing and granted standard review status to its supplemental Biologics License Application (sBLA) for XIAFLEX® (collagenase clostridium histolyticum, or CCH), a novel, in-office biologic therapy for the treatment of Peyronie's disease (PD).
XIAFLEX is currently approved in the United States, European Union, Canada, and Switzerland for the treatment of adult Dupuytrenâ€™s contracture patients with a palpable cord. XIAFLEX for the treatment of PD was granted orphan designation in the United States by the FDA in January 1996, and if approved by the FDA, is expected to be the first and only biologic therapy indicated for the treatment of PD.
The sBLA submission of XIAFLEX for the treatment of PD is based on data from the clinical studies known by the acronym IMPRESS The Investigation for Maximal Peyronieâ€™s Reduction Efficacy and Safety Studies and other controlled and uncontrolled clinical studies, in which more than 1,000 PD patients were enrolled and received more than 7,400 injections of XIAFLEX. In the 2 identical phase 3, double-blind, placebo-controlled IMPRESS studies, XIAFLEX demonstrated statistically significant improvement in the coprimary end points of penile curvature deformity and patient-reported bother vs placebo. In IMPRESS I at 52 weeks, the coprimary end points met stastatistical significance with a 37.6% mean reduction in penile curvature deformity for XIAFLEX subjects (P=.0005) and a 3.3-point improvement in the Peyronieâ€™s Disease Questionnaire (PDQ) bother domain for XIAFLEX subjects (P=.0451).
In IMPRESS II at 52 weeks, the coprimary end points met statistical significance, with a 30.5% mean improvement in penile curvature deformity for XIAFLEX subjects (P=.0059) and a 2.4-point improvement in the PDQ bother domain for XIAFLEX subjects (P=.0496). XIAFLEX was generally well tolerated. The most common treatment-related adverse events reported in the phase 3 studies were local to the treatment site and consistent with adverse events reported in previous PD trials with XIAFLEX, which included injection-site hematoma, pain, and swelling. Serious adverse events included corporal rupture (penile fracture) in 3 subjects in the placebo-controlled studies.
PD is the development of collagen plaque, or scar tissue, on the shaft of the penis that may harden and reduce flexibility, causing the penis to deform in a bend or arc during erection. PD is commonly associated with significant disease bother, emotional distress, loss of self-esteem, and depression, in addition to difficulty with sexual intercourse. PD is a heterogeneous disease with an initial inflammatory component.
IMPRESS is Auxiliumâ€™s late-stage global development plan for XIAFLEX and consists of 4 clinical studies. There are 2 identical randomized, double-blind, placebo-controlled phase 3 studies, which enrolled more 800 patients combined at 64 sites in the United States and Australia in less than 5 months, with a 2:1 ratio of XIAFLEX to placebo. There is also one open-label study, which enrolled at least 250 patients at approximately 30 sites in the United States, European Union, and New Zealand, and one pharmacokinetic study, which enrolled approximately 20 patients who were then enrolled into the open-label study. XIAFLEX was administered 2 times a week every 6 weeks for up to 4 treatment cycles (2 Ã— 4). Each treatment cycle was followed by a penile-modeling procedure. Patients were followed for 52 weeks postâ€“first injection in the double-blind studies and were followed for 36 weeks in the open-label and pharmacokinetic trials.
The trialsâ€™ coprimary end points are percent improvement from baseline in penile curvature deformity compared with placebo and the change from baseline (improvement) in the PD bother domain of the PDQ compared with placebo. The PDQ also has 2 additional domains as secondary end points, which include severity of psychological and physical symp-