Avanir Pharmaceuticals announced favorable results for its trial of Neurodex (dextromethorphan plus quinidine) for the treatment of pseudobulbar affect in people living with Multiple Sclerosis (MS). Pseudobulbar affect is characterized by spontaneous or unmotivated laughing or crying. In this double-blind, placebo controlled study participants were randomized to receive either the placebo or Neurodex every 12 hours for 90 days.
The Center for Neurologic Study Lability Scale (CNS-LS) was used to assess the frequency and severity of pseudobulbar affect episodes. The primary endpoint of the study was a greater reduction in the number of episodes of those taking Neurodex versus those participants who received placebo. Also, four secondary endpoints were published and included the reduction of pseudobulbar affect, increased quality of life perception, increased quality of relationships, and the reduction of pain.
The side effects reported for Neurodex were mild to moderate and included a statistical difference of dizziness for those who took Neurodex versus those given placebo. More participants quit the trial due to adverse events than the group who received placebo, but the difference was not statistically significant.
According to Avanir, the results of this recent trial parallel the results of a previous trial, which included ALS patients. The primary and secondary endpoints were the same for both trials with the exception of one added endpoint (pain reduction) for MS.
Posted on October 17, 2008
