Nearly three years ago the FDA told Avanir Pharmaceuticals to take its application for Zenvia and go back to the drawing board, requiring the developer to reformulate the drug and test it in a new clinical trial to satisfy regulators of the drug's safety. This morning the company said that the reformulated therapy hit its primary endpoint-significantly cutting down on the number of emotional outbursts linked to a neurological disorder-and Avanir's stock almost immediately doubled in value.
A variety of neurological diseases such as multiple sclerosis and Lou Gehrig's disease trigger bursts of uncontrollable crying and laughing in an estimated two million Americans. Trauma from stroke can have the same effect. But in a new trial, researchers reformulated Zenvia so that it included only a fraction of the earlier amount of quinidine, an ingredient that raised safety concerns related to a change in heart rhythm. In the new study, the therapy reduced the number of outbursts by 47.2 percent compared to a placebo. The primary goal was a 36 percent drop in outbursts. Researchers say they saw no indications of added cardiovascular risk.
"We are very encouraged by the top-line results and we believe that the STAR data should be sufficient to address the issues outlined in the FDA approvable letter," said Avanir CEO Keith Katkin. "We hope to have a full presentation of the STAR trial results at a scientific meeting later this year and plan to submit our complete response to the FDA in the first half of 2010."