Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones.
In October 2010, the U.S. Food and Drug Administration (FDA) approved NUEDEXTA®, a unique proprietary combination of dextromethorphan/quinidine, for the treatment of pseudobulbar affect (PBA). The company commenced promotion of NUEDEXTA in February 2011.
In addition to the company’s focus on products for the central nervous system, Avanir also has partnered programs in other therapeutic areas. Avanir’s first commercialized product, 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 FDA. In 2008, the company licensed out all of its monoclonal antibodies and associated platforms and remains eligible to receive milestone payments and royalties related to the sale of these assets.
Avanir is headquartered in Aliso Viejo, California
Technology and Product Information
AVP-923 is a combination of two well-characterized compounds: the active ingredient dextromethorphan hydrobromide, orDM (an uncompetitive NMDA receptor antagonist and sigma-1 agonist) and the enzyme inhibitor quinidine sulfate, or Q (a CYP450 2D6 inhibitor), which serves to increase the bioavailability of dextromethorphan.
The dosage form of AVP-923 of 20 mg DM/10 mg Q (twice daily) is approved by the FDA under the brand name NUEDEXTA capsules which is indicated for the treatment of pseudobulbar affect (PBA).
Patients suffering from existing neurologic disease or brain injury may also suffer the added burden of pseudobulbar affect, or PBA. PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the patient's underlying emotional state. PBA outbursts result from a "short circuit" in the brain caused by another neurologic condition-such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), stroke, or traumatic brain injury. PBA can have a debilitating impact on the lives of patients, caregivers and loved ones. For more information about PBA, please visit www.PBAinfo.org.
The company is also studying AVP-923 for use in different types of neuropathic pain. In April 2011, the company filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a large Phase II clinical trial of AVP-923, an investigational drug for the treatment of central neuropathic pain in patients with multiple sclerosis (MS). Avanir expects to enroll approximately 400 patients both in the US and internationally. The company enrolled the first patient into the trial in November 2011.
AVP-923 has also successfully completed a Phase III trial for the treatment of patients with diabetic peripheral neuropathic pain.