Time to sustained remission of pseudobulbar affect
(PBA) episodes after treatment with dextromethorphan and quinidine
119: SUMMARY OF CARDIAC SAFETY FROM A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF DEXTROMETHORPHAN/QUINIDINE (STAR) FOR TREATMENT OF PSEUDOBULBAR AFFECT
Presentation Details: Title: Study of Pseudobulbar Affect
Symptoms in Veterans With Mild Traumatic Brain Abstract Number: P5.
About Pseudobulbar Affect
People with pseudobulbar affect
(PBA) have sudden outbursts of involuntary crying or laughing, even though there may not be anything particularly sad or funny to trigger those emotions.
The STAR (Safety, Tolerability and Efficacy Results of AVP-923 in PBA) trial was a confirmatory Phase III trial of Zenvia in patients with pseudobulbar affect
AVANIR's lead product candidate, Zenvia[TM], is being developed for the treatment of pseudobulbar affect
(PBA) and has successfully completed a Phase III trial for diabetic peripheral neuropathic (DPN) pain.
Patent number 8,227,484, entitled "Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders," claims methods for treating pseudobulbar affect
or emotional lability using low-dose quinidine formulations of NUEDEXTA.
The increase in net loss is primarily attributed to increased spending in fiscal 2009 on the confirmatory Phase III STAR clinical trial, as well as additional pre-clinical and clinical studies to enhance our complete response to the approvable letter received in 2006 for Zenvia in pseudobulbar affect
This asset is a dual sigma-1 and NMDA receptor modulator that is approved for the treatment of pseudobulbar affect
(PBA), and is in clinical development for central neuropathic pain in patients with multiple sclerosis and agitation in patients with Alzheimer's disease.
It is the only company that has an FDA-approved drug, NUEDEXTA (dextromethorphan HBr and quinidine sulfate), which treats pseudobulbar affect