Avanir Pharmaceuticals reaches agreement with FDA
Avanir Pharmaceuticals (Nasdaq: AVNR) announced ahead of the opening this morning that it reached an agreement with the U.S. Food and Drug Administration, under the FDA’s Special Protocol Assessment process, to design a single confirmatory Phase III clinical trial for Zenvia, which treats patients with pseudobulbar affect.
Pseudobulbar affect is a condition associated with neurological disorders, including involuntary emotional expression disorder such as uncontrollable laughing and/or crying. Neurological disorders include, but are not limited to multiple sclerosis, Alzheimer's disease, Parkinson's disease and stroke.
Shares of Avanir (AVNR) popped 38.54%, or $0.79, to $2.84 out of the gate. Shares of Avanir have been trading in the range of $1.07 to $9.41 for the past 52 weeks.
