"Neurological disorders and brain injuries can affect patients' lives in devastating ways, but one consequence, PBA, is frequently overlooked or misdiagnosed," said Hillel Panitch, MD, Professor of Neurology at the University of Vermont College of Medicine and Director of the Multiple Sclerosis Center at Fletcher Allen Health Care in Burlington, Vermont. "Even though its hallmark characteristics -- uncontrollable laughing and crying -- were described by Charles Darwin more than 130 years ago, the mechanisms underlying PBA are still not clear. However, the debilitating effects of the condition have been well documented. PBA can be seriously disabling in social or occupational settings, adversely affecting the quality of life for patients."

"With no drug currently approved for the treatment of PBA, this NDA submission represents an important step forward in the potential care and treatment of patients suffering from pseudobulbar affect as a result of devastating underlying neurological disease or injury," concluded Dr. Panitch.

Yesterday Avanir announced that their drug Neurodex showed positive results in its final clinical trials. Neurodex will be used for controlling the Pseudo-Bulbar Effect, which is characterized by excessive emotions (emotional lability) such as laughing or crying uncontrollably. This condition affects a segment of the MS population, and if approved, will be the first treatment specifically targeted for this condition (currently doctors prescribe general antidepressants to patients exhibiting symptoms of emotional lability).

While it would of course be better to treat the cause of this rather than control the symptoms, it is a step in the right direction. The company will file for final approval with the FDA by the end of the year.

"...In the latest Phase 3 clinical trial, patients with multiple sclerosis who received Neurodex had a statistically significant reduction in the frequency and severity of emotional outbursts compared with those who received a placebo. Those who received the drug also experienced a better quality of life and pain reduction, the company said. Side effects included dizziness..."

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