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Date Posted: 01:51:48 01/21/05 Fri
Author: JamesCramer
Subject: FDA-DARLING!!! Approval will make it SOAR!

FDA-DARLING!!! Approval will make it SOAR!



AVANIR Receives Special FDA Protocol

AVANIR Receives Special Protocol Assessment For Neurodex Neuropathic
Pain Clinical Trial
Wednesday January 12, 9:01 am ET
Phase III Trial to Begin First Half of 2005


SAN DIEGO--(BUSINESS WIRE)--AVANIR Pharmaceuticals
http://www.avanir.com (AMEX:AVN - News) announced that the company
and the U.S. Food and Drug Administration (FDA) have reached
agreement on AVANIR's protocol for a Phase III clinical trial of
Neurodex(TM) in the treatment of painful diabetic neuropathy, a type
of chronic neuropathic pain. The Special Protocol Assessment (SPA)
from the FDA documents agreement on the protocol under which AVANIR
will conduct and analyze the data from a pivotal trial evaluating
the safety and efficacy of Neurodex in the treatment of painful
diabetic neuropathy.
"In the SPA communication, the FDA advised that the clinical design
and analysis plan of our submitted protocol are suitable to provide
evidence of safety and efficacy to support a new drug application
for Neurodex in the treatment of diabetic neuropathic pain," said
James E. Berg, Vice President of Clinical and Regulatory Affairs at
AVANIR. "We look forward to starting this Phase III trial in the
first half of 2005."

Neurodex is comprised of dextromethorphan and an enzyme inhibitor
that slows the rapid metabolism of dextromethorphan in the liver.
Slowing the metabolism of dextromethorphan with the inhibitor makes
it possible to maintain therapeutic levels for a longer period of
time. Neurodex has an anti-excitatory effect by reducing glutamate
through the combined actions of sigma-1 agonist activity and NMDA
receptor antagonism, suggesting utility in treating certain central
nervous system disorders, including neuropathic pain.

The results of a four-week Phase II open label dose escalation
safety study of Neurodex in patients with diabetic neuropathic pain
were reported in November at the 2004 annual meeting of the American
Society of Regional Anesthesia and Pain Medicine. Study data
demonstrated that Neurodex was well tolerated up to the highest
target dose, and patients reported decreased pain intensity that was
significantly different from baseline (p less than 0.0001). The
degree of pain relief increased with duration of the open label
study.

AVANIR Pharmaceuticals is a drug discovery and development company
focused on treatments for chronic diseases. Our product candidates
address therapeutic markets that include central nervous system and
cardiovascular disorders, inflammation and infectious disease. The
Company's first commercialized product, AbrevaŽ, is marketed in
North America by GlaxoSmithKline Consumer Healthcare and is the
leading over-the-counter product for the treatment of cold sores.
Further information about AVANIR can be found at www.avanir.com.

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