Less than three months after Avanir Pharmaceuticals Inc. completed the rolling submission of a new drug application for its pseudobulbar affect drug, Neurodex, the FDA has requested more information - meaning a decision probably won't come by the end of this year as originally expected.
Specifically, the FDA asked the San Diego-based company to provide an expansion of certain summary analyses in its application to better support new electronic data submission guidelines. Avanir expects to meet with the agency in the next few weeks to discuss the request.
Avanir submitted data to the FDA over a six-month period ending in June, when it completed the rolling NDA filing. It was expecting an FDA decision within six months. (See BioWorld Today, July 1, 2005.)
Pseudobulbar affect (PBA) is a neurological condition characterized by an emotional loss of control. It also is known as pathological laughing and crying, emotional lability and emotional incontinence.
Neurodex is made of dextromethorphan and an enzyme inhibitor that slows the otherwise rapid metabolism of dextromethorphan, which might work to control PBA by reducing excessive glutamate excitatory neurotransmission.
The submission included data from two controlled, multicenter Phase III trials of PBA: one in amyotrophic lateral sclerosis patients and the other in multiple sclerosis patients. In the first trial, the Neurodex arm showed statistically and clinically greater improvements than both the dextromethorphan arm and the quinidine arm in the primary efficacy endpoint, change in the Center for Neurological Study Lability Scale. In the second trial, Neurodex patients had a significantly greater reduction in that score than those receiving placebo.
The compound also is being developed in a Phase III trial to treat diabetic neuropathic pain.
The company's stock (AMEX:AVN) fell 24 cents Thursday to close at $3.06.