The Company also has a number of partnered programs in other therapeutic areas. Its docosanol 10% cream, sold in the United States and Canada as Abreva by its marketing partner GlaxoSmithKline Consumer Healthcare, is the only over-the-counter treatment for cold sores that has been approved by the United Sates Food and Drug Administration (FDA). In October 2010, FDA approved NUEDEXTA, is a combination of dextromethorphan/quinidine, for the treatment of pseudobulbar affect (PBA).
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http://www.avanir.comNUEDEXTA
NUEDEXTA is the FDA-approved treatment for PBA, which occurs secondary to a range of neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes occur out of proportion or incongruent to the patient’s underlying emotional state. NUEDEXTA is a combination of two components: dextromethorphan hydrobromide, the ingredient active in the central nervous system, and quinidine sulfate, a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA acts on sigma-1 and N-Methyl-D-aspartic acid (NMDA), receptors in the brain.
AVP-923
Diabetic peripheral neuropathic pain (DPN pain), which arises from nerve injury, can result in a chronic and debilitating form of pain. AVANIR has completed a Phase III clinical trial for AVP-923 in the treatment of patients with DPN pain. AVP-923 also demonstrated improvements in a number of key secondary endpoints, including the pain relief ratings scale and the pain intensity ratings scale. In September 2009, it reported on secondary efficacy endpoints from the double-blind phase of the AVP-923 STAR trail in PBA, including an endpoint measuring reduction of pain in patients with underlying multiple sclerosis (MS).
Docosanol 10% Cream
Docosanol 10% cream is a topical treatment for cold sores. GSK markets the product under the name Abreva in the United States and Canada. It purchases the active pharmaceutical ingredient (API), docosanol, from a large supplier in Western Europe and has, on occasion, sold material to its licensees. It stores its API in the United States.
Xenerex Human Antibody Technology
The Company had an asset purchase and license agreement with Emergent Biosolutions for the sale of its anthrax antibodies and license to use its Xenerex Technology platform, which was used to generate human antibodies to target antigens. Under the terms of the agreement, it is eligible to receive payments and royalties on any product sales generated from this program. It had an asset purchase agreement with a San Diego based biotechnology company for the sale of its non-anthrax related antibodies, as well as the remaining equipment and supplies associated with the Xenerex Technology platform.
The Company competes with Biovail Corporation and GSK.
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