Arena announces successful lorcaserin safety review

SAN DIEGO Arena Pharmaceuticals announced this week that the results of a 12-month safety review of its obesity drug lorcaserin has found no heart valve problems and that the drug was safe for use, according to published reports.

The drug blocks appetite signals in the brain. There have been concerns though that drug may have a fatal side effect, heart valve damage. Redux, lorcaserin’s parent drug, manufactured by Wyeth, was pulled off the market because it was linked to heart valve damage. But, the difference between the drugs is that Redux was hitting too many biological receptors on top of the one that reduces appetite.

The Echocardiographic Data Safety Monitoring Board had monitored 3,200 clinical trial participants using the drug. “This critical milestone assessing month-12 echocardiographic data strongly supports lorcaserin’s cardiovascular safety profile,” Arena chief executive officer Jack Lief said in a statement.

The safety board will not meet again on this drug, but Arena will continue to collect heart safety data after 18 months and 24 months of the two-year study known as the Bloom trial. Patients have begun enrollment in the Bloom trial and will be for one year and include people previously diagnosed with a heart valve disorder. A third trial for the drug, for people with Type 2 diabetes, is now under way.

Final data from the trials is expected in 2009, which the company hopes will help it to file an application with the Food and Drug Administration before the end of 2009.