Avanir Pharmaceuticals (NASDAQ:AVNR) said Tuesday that one of its new novel drugs may help reduce involuntary laughing and crying in patients with neurological diseases.
The biopharmaceutical company, focused on patients with central nervous system disorders, published the results of the Phase III STAR trial in the Annals of Neurology.
The AVP-923 investigative drug, made up from Dextromethorphan and a small dose of Quinidine, was compared to placebo in the treatment of Pseudobulbar affect [PBA] in patients with amyotrophic lateral sclerosis [ALS] or multiple sclerosis [MS].
PBA is a neurologic condition characterized by involuntary, unpredictable and disruptive outbursts of laughing or crying in patients with the underlying brain disorders.
“Outbursts of crying or laughter at inappropriate times can have a severe impact on patients,” said study author Erik P. Pioro, director of the section for ALS and related disorders at the Cleveland Clinic in Cleveland, Ohio.
“In the STAR trial, both doses of AVP-923 markedly reduced the frequency and severity of PBA episodes with satisfactory safety and tolerability,” he said.
The findings further evidences the potential for the drug to help neurologic patients suffering from PBA, according to Pioro.
The STAR trial, or Safety, Tolerability and Efficacy Results, is a randomized, controlled test compared to placebo over a 12-week span, followed by another 12-weeks of safety study. For this trial, 326 PBA-suffering patients enrolled.