Avanir, a pharmaceutical company developing treatments for CNS disorders and inflammatory diseases, announced that its multiple sclerosis (MS) drug Zenvia met its goal in a six-month clinical trial. The data showed that the low-dose version of Zenvia significantly reduced the number and severity of emotional outbursts in patients with MS. Shares in Avanir jumped nearly 10 percent following the announcement.
Prior to this, the longest trial of Zenvia lasted 12 weeks. The most recent trial gave researchers the chance to evaluate the safety, efficacy, and tolerability of Zenvia over an extended period of time. Zenvia had a low rate of adverse events. Three years ago, Avanir had to reformulate Zenvia due to concerns about the ingredient quinidine, which is thought to affect heart rhythm in some patients. In August, it was announced that a Phase III study of Zenvia found no added cardiovascular risk. Avanir plans to submit a complete response for FDA approval in the second quarter of 2010.
MS can cause uncontrollable crying or laughter in some patients, a condition known as pseudobulbar affect. Because MS damages the brain and spinal cord, other symptoms of cognitive dysfunction may also be present. Patients may experience forgetfulness, depression, or the inability to concentrate. Some companies developing treatments for MS include BioMS Medical, Bayhill Therapeutics, ReceptoPharm, Transition Therapeutics, ChemoCentryx, and NovImmune.