FDA Withholds OK of Involuntary
Emotional Expression Drug

The experimental drug Zenvia (formerly referred to as Neurodex), developed by Avanir Pharmaceuticals of San Diego for the treatment of unwanted emotional expression, won’t be approved by the U.S. Food and Drug Administration (FDA) until additional data on safety and effectiveness have been supplied, according to Avanir.

The company had hoped to market the drug for the treatment of “involuntary emotional expression disorder” (IEED), a condition associated with certain types of brain injuries and neurologic disorders, including amyotrophic lateral sclerosis (ALS). (The phenomenon, which involves episodes of uncontrollable laughing or crying, is also known as “pseudobulbar affect,” and is thought to occur because of changes in signaling pathways in the brain.)

In 2002, a trial that included 140 people with ALS showed the drug reduced the frequency of IEED episodes and improved quality of life. A current clinical trial of Zenvia, open since 2003, will remain open until at least March 1, the company says.

Avanir anticipates scheduling a meeting with the FDA to discuss the agency’s additional requirements.

In addition, it notes, Avanir “cannot be certain that once it has met with the FDA, that it will choose to continue with the development of Zenvia as previously planned.”

“Unfortunately, it seems we may still have more work to do,” said James Berg, vice president of Clinical and Regulatory Affairs at Avanir. “It makes me sorry for all of the people that could use this drug and need it.”