UPDATE 3-FDA advisors vote against two drugs for menopausal hot flashes

Mon Mar 4, 2013 6:33pm EST

* U.S. FDA advisory panel votes to reject Depomed's Sefelsa
    * Panel also rejects Noven Pharmaceuticals menopause drug
    * Advisors say neither drug confers enough benefit
    * Depomed shares fall 9.8 percent

 (Adds panel's rejection of Noven drug)
    By Toni Clarke
    WASHINGTON, March 4 (Reuters) - Advisers to the U.S. Food
and Drug Administration on Monday voted against approval of two
drugs designed to reduce the frequency and severity of hot
flashes associated with menopause, concluding that neither
conferred enough benefit to offset their risk.
    The panel voted 12-2 against a drug made by Depomed Inc
, sending the company's shares down 9.8 percent to $5.89
 on the Nasdaq. Depomed's shares fell as low as $5.12
immediately after they resumed trading following a halt pending
the results of the panel's meeting.
    The panel also voted 10-4 against approving a drug for hot
flashes made by Hisamitsu Pharmaceutical Co Inc's 
subsidiary Noven Pharmaceuticals Inc.
    The drugs would have been the first non-hormonal therapies
for hot flashes to have been approved by the FDA. The use of
hormone therapy has dropped significantly since 2002, when
findings from a large clinical trial showed the therapies could
increase the risk of heart attack and stroke.
    Hot flashes affect some 75 percent of the estimated 32
million women in the United States experiencing menopause each
year, Depomed said. Hot flashes, characterized by warmth,
flushing and sweating, can be disruptive, and can last anywhere
from a few years to more than a decade.
    
    CONCERNS ABOUT SUICIDE RISK
    Depomed's drug, Sefelsa, is a long-acting version of the
epilepsy drug gabapentin. A short-acting version of gabapentin,
made by Pfizer Inc and marketed as Neurontin, was
approved in 1993.
    Clinical trials of Sefelsa showed it only partially reduced
the frequency and severity of hot flashes, while side effects
included dizziness, sleepiness, headache and nausea. Gabapentin
has also been shown to increase the risk of suicide.
    Similarly, Noven's drug did not meet all the goals it was
supposed to meet in a clinical trial and panel members felt it
was difficult to assess how beneficial the treatment was since
many patients taking the placebo also improved.
    The FDA does not have to follow the recommendations of its
advisory panels, but it generally does.
    Depomed said it would cease spending on Sefelsa.
    "We recognize and appreciate the concerns that were raised
by the members of the Advisory Committee," Jim Schoeneck,
Depomed's chief executive officer, said in a statement. "Based
on today's meeting, we believe the hurdles for approval of a
non-hormonal treatment for hot flashes remain high."
    Extended-release gabapentin was approved in the United
States in 2011 to treat shingles-related pain. It is marketed by
Depomed under the brand Gralise.
    Noven's drug comprises a low dose of the antidepressant
paroxetine mesylate. The company sells a higher-dose version of
the drug under the brand Pexeva for, among other things,
depression, obsessive-compulsive disorder and generalized
anxiety. A similar drug, Paxil, is made by GlaxoSmithKline Plc
.
    "The FDA's advisors did a great job today of carefully
considering the scientific evidence," said Diana Zuckerman,
president of the National Research Center for Women & Families,
a nonprofit organization that promotes health and safety of
children and adults.
    "We strongly urge the FDA to listen to these advisors and
reject the applications of both companies."
    Risks associated with paroxetine include an increase in
suicidal thinking.
    "While we are disappointed in today's outcome, we appreciate
the discussion and will work closely with the FDA as it
completes its ongoing evaluation," said Dr. Joel Lippman,
Noven's chief medical officer.
    He reiterated the company's belief that the trial data
support the use of the drug as safe and effective.

 (Reporting by Toni Clarke; Editing by Gerald E. McCormick,
Sofina Mirza-Reid, Dale Hudson and Jan Paschal)
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