 Avanir Pharmaceuticals, Inc. (Nasdaq: AVNR) is a biopharmaceutical company focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of central nervous system disorders.
Avanir's lead product candidate, Zenvia™, is being developed for the treatment of pseudobulbar affect (PBA) and diabetic peripheral neuropathic (DPN) pain. The company has successfully completed a confirmatory Phase III study under a Special Protocol Assessment (SPA) agreement with the FDA utilizing a new lower quinidine dose formulation of Zenvia intended to address safety concerns raised in the FDA's approvable letter for Zenvia in the treatment of PBA. In addition, Avanir has conducted a Phase III study of Zenvia in DPN pain where the primary endpoints were successfully met. Avanir is now engaged in discussions with the FDA under the SPA process regarding the design of the next Phase III study in DPN pain and overall program requirements.
Avanir has licensed its macrophage migration inhibitory factor (MIF) program to Novartis International Pharmaceutical Ltd. and has sold its anthrax monoclonal antibody program to Emergent BioSolutions. The Company's first commercialized product, abreva® (docosanol), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. |