Last week, Peritech Pharma, a specialty anal-rectal pharmaceutical company, announced positive pivotal trial results for its lead product, PP-110, a novel over-the-counter (OTC) anti-hemorrhoidal product. PP-110 was found to be effective in treating hemorrhoids and superior to conventional treatment.
The study compared the safety and efficacy of PP-110, a novel treatment for hemorrhoids, with the Pfizer's Preparation-H Maximum Strength Cream, in the treatment of grade 23 hemorrhoids. Over 100 patients participated in the 14 day study that was conducted in 7 sites by a team of physicians headed by Professor Ehud Klein, Director of Surgery Service Line at Maccabi Health Services, Tel-Aviv, Israel. PP-110 (in gel and wipes form) was provided to some patients once daily, while other patients received Preparation-H Extra Strength (Pfizer) per label (i.e. 3-4 times per day). Patients receiving PP-110 gel reported statistically significant better results in the three most prevalent clinical parameters relating to common symptoms of hemorrhoids, namely pain, bleeding and itching, compared to patients treated with the comparator.
"The pivotal trial results are very encouraging and exceed our expectations," said Prof. Ehud Klein, Director of Surgery Service Line at Maccabi Health Services, Tel-Aviv, Israel, "We found that the unique formulation of PP-110 provides a long lasting effect, and were extremely pleased to see that even once-daily application is sufficient, which offers patients a true improvement over current topical treatment."
The company also announced the receipt of a US patent for PP-110.
"Our novel film-based formulation provides a slow-release mechanism, and as a consequence, a prolonged therapeutic window,” said Peritech Pharma CEO Dr. Eran Eilat, “We are very pleased with the pivotal trial results that clearly demonstrate the benefits our product offers hemorrhoid patients. Together with the recently granted US patent, and under the monograph regulatory track, PP-110 is ready to be marketed and is now well positioned to revolutionize the hemorrhoids OTC market, especially in the United States."
Published by Globes [online], Israel business news - www.globes-online.com - on July 26, 2015
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