Izun Pharmaceuticals Reports Positive Data for Oral PerioPatch® in the Treatment of Periodontitis
February 24, 2015
PerioPatch®, a novel oral trans-mucosal patch system that reduces inflammation and promotes tissue repair, has been shown to significantly reduce pocket depth (PD) and to generate an increase in attachment level (AL) in patients with advanced periodontal disease
Izun Pharmaceuticals Corporation an emerging specialty pharmaceutical company in New York which focuses on developing best in class pharmaceutical products derived from botanical sources today reported the results of a clinical study conducted at the University of North Carolina Chapel Hill (“UNC”). The 80 patient study compared scaling and root planing (SRP) in conjunction with PerioPatch treatment versus SRP alone. The study demonstrated that PerioPatch treatment significantly reduced pocket depth (PD) and increased attachment level (AL) gain relative to control group in treated patients with advanced periodontal disease.
David W. Paquette, DMD, MPH, DMSc, of Stony Brook University School of Dental Medicine, who designed and oversaw the clinical trial remarked, “This clinical study demonstrates that adjunctive PerioPatch treatment reduces the signs of inflammatory periodontal disease beyond conventional therapy. This outcome is a major improvement in the management of periodontal disease in patients. Additionally, PerioPatch represents the first topical anti-inflammatory product that may be applied by both professionals and patients.”
These findings clinically confirm animal data and other clinical trials that the use of PerioPatch will assist in repairing the damage to the gums that develops from periodontal disease. Both primary (reduction of PD) and secondary (AL gain) endpoints of the study were met and were statistically significant. These significant improvements were evident at one month and continued to improve at two and three months, which represented the completion of the evaluation period. The current data extend previously published clinical reports which demonstrated that the PerioPatch can improve the above parameters as well as decrease bleeding upon probing and gingival inflammation at 2, 4 and 6 weeks.
Pre-clinical studies in animal trials demonstrated that treatment with PerioPatch results in more rapid healing as a result of increased collagen production and accelerated tissue revascularization. Such data correlate well with the gingival repair that was noted both in the UNC study and in previously conducted clinical trials.
Dr. William Levine, CEO and Chairman of Izun Pharmaceuticals Corp. stated, “Results of the UNC study support the conclusion that PerioPatch is a breakthrough treatment for periodontal disease and is the most effective topical oral product for reducing gingival inflammation and promoting healing. PerioPatch should thus be integrated into the routine treatment protocol for periodontal disease, a market with estimated annual sales of $2 billion in 2017.”
PerioPatch has regulatory approval in the United States and Canada, as well as in the European Union.