A clinical trial of a novel over-the-counter gel developed by Peritech Pharma in Yavneh, Israel, proved it effective in treating hemorrhoids and superior to conventional treatment.
The randomized, open-label study compared the safety and efficacy of Peritech’s PP-110 with the US gold standard, Pfizer’s Preparation-H Maximum Strength Cream. More than 100 patients participated in the 14-day study conducted in seven sites by a team of physicians headed by Prof. Ehud Klein, director of surgery services at Maccabi Health Services in Tel Aviv.
PP-110 (in gel and wipes form) was provided to some patients once daily, while other patients received Preparation-H Extra Strength per label instructions, three to four times per day. Patients using the PP-110 gel reported statistically significant better results in the three most prevalent clinical parameters relating to common symptoms of hemorrhoids — pain, bleeding and itching — compared to patients treated with Preparation-H.
PP-110, recently awarded a US patent, takes two approved active ingredients (pramoxine 1% and phenylephrine 0.25%) and puts them into an innovative delivery system. When applied, the gel leaves a thin film to ensure long-term contact of the active ingredients with the affected tissue.
The results of the study were published online July 3 in Molecular and Cellular Therapies.
“Our novel film-based formulation provides a slow-release mechanism, and as a consequence, a prolonged therapeutic window,” said Dr. Eran Eilat, CEO of Peritech Pharma.
Eilat said the product “is ready to be marketed and is now well positioned to revolutionize the hemorrhoids OTC market, especially in the United States.”
About 50 percent of Americans suffer from hemorrhoids at some point during their life. Some 10% of American adults (22 million people) have experienced hemorrhoids during the past year. The worldwide market for OTC hemorrhoids products is estimated at $1 billion annually.
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