(Corrects name of drug throughout to Nuedexta instead of
Zenvia. The drug was previously called Zenvia)
* FDA OKs first product to treat pseudobulbar affect
* Analysts see peak annual sales up to $500 million
* Shares rise 15 percent
NEW YORK, Oct 29 U.S. health regulators on
Friday approved Avanir Pharmaceuticals Inc's AVNR.O Nuedexta,
a treatment for a neurological disorder in which patients
cannot control outbursts of crying or laughter.
U.S. Food and Drug Administration spokeswoman Sandy Walsh
said the agency had approved the long-delayed drug.
Nuedexta is the first drug approved for the treatment of
the little known, but not that rare, condition called
pseudobulbar affect (PBA), which is also known as involuntary
emotional expression disorder.
Analysts expect Nuedexta to garner peak U.S. sales of $350
million to $500 million, and Avanir shares rose 15 percent in
light after-hours trading on Friday.
The approval could make Avanir an attractive acquisition
target for larger companies desperate for new products that
don't carry the risk of FDA rejection faced by promising
PBA affects an estimated two million Americans suffering
from multiple sclerosis, Lou Gehrig's disease (ALS), stroke and
other neurological disorders or trauma that can cause brain
Avanir suffered a major blow four years ago, when the FDA
rejected Nuedexta and asked for new trials due to safety
concerns. The FDA was uneasy about the heart rhythm impact of
quinidine, a component of the drug used to increase the amount
of the active ingredient, dextromethorphan, in the body.
The agency asked Avanir to go back and perform new trials
with only a third as much quinidine -- 10 milligrams instead of
30 mg. In August of 2009, Avanir said its reformulated Nuedexta
met the main goal of the new pivotal study by significantly
reducing the emotional outbursts tied to PBA .
The FDA accepted the resubmission of Avanir's marketing
application in May, paving the way for Friday's approval.
Many investors may have been betting on another delay as
Avanir shares fell nearly 14 percent to $2.42 on Nasdaq before
the FDA announced the approval.
Avanir shares rose to $2.79 in light extended trading.
(Reporting by Krishnakali Sengupta and Shravya Jain in
Bangalore; additional reporting by Bill Berkrot in New York and
Susan Heavey in Washington; editing by Carol Bishopric)