Arena’s Obesity-fighting drug proved Safe

Arena Pharmaceuticals Inc. announced that it has succeeded in its experimental endeavor to fight obesity. The company’s investigational pill lorcaserin has passed tests confirming that there are no heart safety issues after 12 months of use. It is expected to hit the shelves in 2010.

Concerns stemmed from a similar Wyeth combination treatment, comprising of fenfluramine and phentermine, which had to be withdrawn from the market in September 1997, after reports of valvular heart disease and pulmonary hypertension.

Arena’s drug was tested on 3,200 patients for one year and it was found that it presented no risk to the heart at all.

The drug was labeled as ‘safe’ by an independent Echocardiographic Data Safety Monitoring Board, which said the trial could be continued. The effectiveness results of the trial will be discovered within another year.

"We believe that this exposure duration, even under a conservative interpretation of the literature, would have been sufficient to observe a fenfluramine like effect on heart valves if present," said Jack Lief, Arena's president and chief executive in a statement.

The drug produced by the San Diego-based Biopharmaceutical Company works by stimulating a protein in the brain which raises the satiety level, making the person feel full.

Wyeth's former treatment worked in a similar manner by stimulating a receptor in the brain.

Arena, however, believes its compound has minimal activity on a different receptor that could have been the culprit in the heart valve damage from fen-phen.

A previous, three-month long study of Lorcaserin, showed that people who took the drug lost about eight pounds in the period, while those who were taking placebo pills lost only one pound or less.

Arena holds all the rights to lorcaserin, and is in no rush to sign a partnership with companies interested in the product. The drug-maker assumes that after the drug’s safety and effectiveness is proved in the last year of trial, it will receive many decent partnership offers.