Dextromethorphan/quinidine (Zenvia) is safe to treat pseudobulbar affect: Avanir

Dextromethorphan/quinidine (Zenvia) is safe and effective in treating the neurologic disease Pseudobulbar affect (PBA), annouced Avanir Pharmaceuticals, Inc.

Dextromethorphan/quinidine (Zenvia) is a combination of two well-characterized compounds: the therapeutically active ingredient dextromethorphan and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan.

This first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways: through presynaptic inhibition of glutamate release via sigma-1 receptor agonist activity and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity.

Zenvia has completed a confirmatory Phase III trial in the treatment of pseudobulbar affect (PBA) and has successfully completed a Phase III trial for diabetic peripheral neuropathic (DPN) pain.

In October 2006, the Company received an FDA approvable letter for Zenvia in the treatment of PBA. The Company conducted the confirmatory Phase III STAR trial under a Special Protocol Assessment (SPA) agreement with the FDA with the goal of addressing safety concerns raised in the Agency’s approvable letter for Zenvia in the treatment of PBA.

Avanir plans to file a full response to the approvable letter in the second calendar quarter of 2010, with an FDA approval decision expected in the fourth calendar quarter.

Avanir Pharmaceuticals presented data from the double-blind phase and the open label extension of the Phase III confirmatory STAR trial.

“We are very pleased that these important data have been accepted for presentation at the AAN Annual Meeting and that the long-term efficacy data were selected for inclusion in the Late-Breaking Science program,” stated Randall Kaye, MD, Avanir’s Chief Medical Officer.

What is Pseudobulbar Affect?

Pseudobulbar affect (PBA) is a neurologic condition characterized by involuntary, sudden, and frequent episodes of laughing and/or crying in patients with underlying neurologic disease or injury.

PBA episodes typically occur out of proportion or incongruent to the underlying emotional state.

In addition to the burden of the underlying neurologic disorder, PBA can have a number of problematic individual and socially disabling consequences, which may depend upon the frequency and severity of the laughing and crying episodes.

The etiology of PBA is not completely understood but the symptoms of PBA are similar across patient populations.

The pathophysiology of PBA is widely believed to involve injury to the neurologic pathways that regulate affect.

PBA is estimated to occur in 49% of patients with ALS, in 10% of patients with MS, in 11% of patients 1 year after suffering a stroke, and in 11% of patients after a traumatic brain injury.

PBA has also been reported secondary to a number of other neurologic conditions. There are currently no FDA-approved treatments for PBA.

Avanir Pharmaceuticals, Inc., 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, has completed a confirmatory phase III trial in the treatment of pseudobulbar affect (PBA) and has successfully completed a phase III trial for diabetic peripheral neuropathic (DPN) pain.

Avanir plans to file an application for regulatory approval in the PBA indication in the second calendar quarter of 2010, with an FDA approval decision expected in the fourth calendar quarter.

Avanir 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.