Avanir Presents Pivotal Neurodex Clinical Trial Data

Avanir Pharmaceuticals has released data from its Phase III clinical trial examining Neurodex in the treatment of pseudobulbar affect (PBA) in patients with multiple sclerosis (MS).

In the double-blind study, 150 MS patients with PBA were randomized to receive either placebo or Neurodex on a 12-hour dosing schedule for 90 days. Eighty-four percent of patients treated with Neurodex reported that their condition improved, compared to 49 percent of those given a placebo.

The study participants kept a diary tracking the number of laughing/crying episodes they experienced each day. According to the researchers, Neurodex-treated patients reported 46 percent fewer laughing and/or crying episodes than those on placebo during the three-month trial. Neurodex-treated patients also reported overall improvement in their quality of life, quality of relationships and in the amount of pain they experienced.

Of the side effects reported in 5 percent or more of the patients, a statistically significant difference between Neurodex and placebo was observed only for dizziness. In the Neurodex group, 14 percent of patients withdrew from therapy because of adverse events, compared to 11 percent discontinuing in the placebo group. The majority of reported side effects were mild to moderate in intensity.