Potential new weight-loss wonder drug

Sep 27 2007

More than 60 percent of American women are overweight, with nearly a third falling into the category of obese and at greater risk of cancer, heart disease and diabetes.

Until now, there has been no safe, long-term medical remedy that tackles unwanted weight gain.

Dr. Nir Barak of Tel Aviv University's Sackler School of Medicine has developed what could be a new weight-loss wonder drug. In conjunction with the drug company Obecure, Dr. Barak developed a new formulation called HistaleanTM, based on betahistine, an approved drug marketed worldwide for the treatment of vertigo. Betahistine has been available to health authorities for over 30 years.

Betahistine is believed to block receptors in the brain – the H1 and H3 receptors – which are connected to one's sense of fullness and desire to eat fatty foods. It has an excellent safety profile and has been used for treatment by more than 100 million patients suffering from vertigo and dizziness in Canada and Europe.

The repurposed pill, Histalean, has been found to quell the desire to consume fatty foods, and the effects have been most pronounced in women.

According to the U.S. Center for Disease Control, about 32% of adult American women under 54 (about 25 million women) suffer from obesity. “Our new results suggest a strong gender-and-age-effect and support the potential of the drug as a breakthrough anti-obesity agent in women 50 years old or less,” confirmed Dr. Yaffa Beck, Obecure's CEO.

According to some estimates, obesity results in thousands of deaths a year and accounts for $117 billion in U.S. health care expenses annually. Clearly, a breakthrough in this area will not only make women look and feel better, but it could save their lives as well.

A recent Phase II clinical trial of the new drug in the U.S. suggests that women under the age of 50 who took Histalean for 12 weeks lost 7 times the weight of those taking a placebo. What's most important to the researchers involved is that none of the 281 patients, males and females aged 18-65, complained of any serious side effects.

The trial, completed this August, was supervised by U.S. weight-loss guru Dr. Robert Kushner. The women who took the pill reported, “It wasn't hard.” “I wasn't thinking about food.” “I was content.”

Dr. Barak explains why this is good news, “All the drugs in the diet pill market today have serious side effects. They may help a woman lose weight, but with that weight loss comes all sorts of bad things like depression and even suicide. Safety issues are a real concern for the FDA. But because this new drug has already been proven safe for other indications, we think Histalean has real blockbuster potential.”

The recent results were based on a double-blind, placebo-controlled study on people with a Body Mass Index ranging from 30 to 40. (A BMI of 30 and above indicate obesity.) The study was conducted at 19 investigation sites across the U.S. over a 12 week treatment period. The subgroup of high-dose Histalean-treated women lost an average of 2.91% of their weight versus placebo group which lost only 0.4 %.

Dr. Barak's drug is also expected to compete for the $28 billion market of cholesterol-reducing drugs such as Lipitor. It could also be used in parallel with anti-psychotic drugs, which have unwanted side effects of extreme weight gain among mental health patients.