Avanir's experimental drug Zenvia appears safe and effective for involuntary emotional expression in ALS
The pharamaceutical company Avanir has announced positive results for its phase 3 trial to treat unwanted episodes of laughing and crying in patients with ALS and multiple sclerosis using its experimental drug Zenvia.
|Contrary to appearances, people usually don’t feel emotional during a laughing or crying episode. For an explanation of this ALS symptom and different ways to deal with it, see "PBA Symptoms No Laughing Matter," MDA ALS Newsmagazine, March 2006.|
Uncontrollable laughing or crying, sometimes called "pseudobulbar affect” (PBA) or “involuntary emotional expression disorder" (IEED), is common in people with ALS and is thought to be caused by degeneration of nerve pathways from the upper brain to the lower (bulbar) brain.
Zenvia (formerly called Neurodex) is a combination of two drugs, dextromethorphan and quinidine. Two dosage formulations were used in the trial: 30 milligrams of dextromethorphan combined with 10 milligrams of quinidine and 20 milligrams of dextromethorphan combined with 10 milligrams of quinidine. Avanir reports both dosages significantly reduced episodes of PBA compared to a placebo. The drug was generally safe and well tolerated.
The company intends to announce complete results from the phase 3 study this fall and to follow guidance from the U.S. Food and Drug Administration (FDA) to gain market approval for Zenvia to treat PBA.
For a thorough discussion of Zenvia in an Aug. 11, 2009, conference call, visit the Avanir Web site and click on the Webcast.