A Phase III trial of Avanir Pharmaceuticals' closely-watched drug Zenvia showed that the drug relieved Pseudobulbar affect (PBA) in a subset of multiple sclerosis patients, sending Avanir's stock up as much as 16 percent. PBA is a neurologic disorder that occurs secondary to neurologic disease or brain injury, causing sudden and uncontrollable bouts of crying, laughing, or other emotional displays. Over the course of the 12-week study, Zenvia met the primary efficacy endpoint by reducing PBA episode rates by an incremental 11.9 percent beyond placebo. A lower dose of the drug did not achieve statistical significance.
"We were very pleased that Zenvia demonstrated significant improvement in PBA episodes in the MS sub-population as well as encouraging proof of concept data in MS-related pain," said Randall Kaye, MD, Avanir's chief medical officer. "This is especially exciting given that the STAR trial was not powered to detect an efficacy signal in such a small number of patients. These data provide additional insight into the clinical utility of Zenvia and help shape our plans for future drug development."
This has been a week of good news for Avanir. Two days ago the company obtained a new patent for Zenvia, which will extend its commercial exclusivity period until well into 2025.
- check out Avanir's release
- here's the Reuters report