AVANIR SUBMITS NDA FOR NEURODEX
AVANIR Pharmaceuticals announced that the company has submitted the final modules of a "rolling" submission of the new drug application (NDA) for Neurodexan investigational new drug, to the FDA as an electronic common technical document.
AVANIR is seeking approval to market Neurodex as a treatment for pseudobulbar affect (PBA), also known as pathological laughing and crying, emotional lability, and emotional incontinence.
Pseudobulbar affect is a neurological condition characterized by the disinhibition or loss of control of the motor expression of emotion. Symptoms of PBA include uncontrollable crying or laughing that is out of context with the social setting. It can be severe, unremitting, and persistent. PBA occurs secondary to neurological disease or injuries including amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease, multiple sclerosis (MS), stroke, traumatic brain injury, and dementias such as Alzheimer's disease. If approved, Neurodex would be the first drug indicated to treat PBA.
The NDA for Neurodex contains data from two controlled, multicenter Phase III clinical trials: one conducted in ALS patients and the other in MS patients. Data was also submitted from its open-label clinical study evaluating the safety of long-term exposure to Neurodexin patients with PBA associated with a variety of neurological disorders. Following the NDA submission, AVANIR will submit additional safety data from the ongoing open-label clinical study, including a 120-day safety update required by FDA regulations.
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