Hemorrhoids are a delicate subject, but for many people 50 and over, a most painful oneThat’s one reason why topical, over-the-counter hemorrhoid medicines are perennial best-sellers – with Pfizer’s Preparation-H among the best selling hemorrhoid drug worldwide.
Best-selling it may be, but a new study published last week in the journal Molecular and Cellular Therapies says that Preparation-H is no longer the most effective OTC hemorrhoid treatment. That crown now belongs to PP-110, an OTC hemorrhoid treatment developed by Israeli med-tech start-up Peritech Pharma.
Hemorrhoids are generally the result of swollen blood vessels in the area of the anus and rectum, and involve a whole host of “tortures,” including rectal pain, itching, bleeding, and, in some cases, a protruding bolus that makes sitting or walking extremely difficult. Some 50% of adults over 50 suffer from hemorrhoids at one time or another. Often people experience bouts of the condition, which then goes into “remission” before resurfacing. American consumers alone spend over $400 million each year on OTC hemorrhoid treatment products.
According to some doctors, hemorrhoids can be aggravated by the consumption of spicy or fatty foods, while others believe that repeated “anal strain” – trying “too hard” when evacuating – is a major cause. In severe cases, treatments can include prescription medicines or even surgery, but most sufferers are able to find some relief with topical medications, spread on the problem areas, to reduce the inflammation in blood vessels.
While most customers appear to be satisfied with Preparation-H, according to industry polls, in a trial pitting PP-110 against the industry leader, Peritech’s product turned out to be the preferred one among study subjects.
The open-label study (in which participants knew they were getting Preparation-H or a “leading competitor”) was randomized, with subjects suffering from Grade II and II hemorrhoids (severe enough to require extensive topical treatments, and possibly surgical procedures). Over 100 patients participated in the 14-day study conducted in seven sites by a team of physicians headed by Professor Ehud Klein, Director of Surgery Service Line at Maccabi Health Services in Tel-Aviv.
While the ingredients of both formulations were similar (Pramoxine-HCl 1% and Phenylephrine 0.25%), it was PP-110’s delivery method – a slow, gradual release of medicine, as opposed to a one-time application – that made the difference, the company said. In the study, patients were either given either PP-110 in gel and/or wipe form once daily, or Preparation-H Extra Strength, the brand’s strongest formulation, as instructed on the label (three or four times a day).
According to the study, 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 results show that subjects receiving PP-110 rated their experience and symptoms as being 10-20% better than the experience provided by Preparation-H – but that was with just one application a day, itself a much greater convenience, the study said.
“The pivotal trial results are very encouraging and exceed our expectations,” said Prof. Klein. “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.”
“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 Ltd. “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.”