* Panel votes 9-9 the drug, Aveed, is safe
* Votes 17-1 that the risk program is insufficient
* Endo shares slip 0.6 percent to $35.75
By Toni Clarke
April 18 An advisory panel to the U.S. Food and
Drug Administration was sharply divided on Thursday over whether
a drug made by Endo Health Solutions Inc can safely be
prescribed for men with low testosterone.
A panel of outside medical experts split 9-9, with some
members saying the drug, Aveed, offers a valuable alternative to
existing products, especially since it is already sold under the
brand name Nebido outside the United States.
Dr. William Cooper, professor of pediatrics and preventive
medicine at Vanderbilt University School of Medicine, said he
did not find anything in the data "of a magnitude that would
make me concerned about the overall safety of the drug."
Others were troubled by the risk associated with the drug of
allergic reactions, which are not always predictable.
"I think there's a real absence of data to prove it's truly
safe," said Dr. Lewis Nelson, director of the fellowship in
medical toxicology at New York University School of Medicine.
Testosterone is a hormone produced in the testicles that is
responsible for maintaining muscle bulk, bone growth and sexual
function. Symptoms of low testosterone can include loss of
libido, depression, decreased muscle mass and fatigue.
Treatments currently include testosterone skin patches,
short-acting injections and topical gels. Aveed is a long-acting
version designed to be given once ever 10 weeks compared with
once every two to four weeks for existing injections.
The panel overwhelmingly agreed that Endo's proposed plan
for managing the drug's risks if it were approved is
The company has offered to instruct physicians to inject the
drug slowly and to make patients wait 30 minutes before leaving
the doctor's office. Some panelists recommended the drug be
administered only in clinics where specialists would be on hand
in case of an adverse reaction.
Others expressed concern that the drug, if approved, would
be used more widely than intended by athletes and others seeking
to enhance performance.
Aveed has twice before been rejected by the FDA based on
concerns about injection-site reactions and the potential for
pulmonary oil microembolisms. Aveed is made of testosterone and
castor oil and the FDA has expressed concern of a risk that the
oil could cause blockages in blood vessels in the lungs.
Mark Woods, director of the pharmacy department at St.
Luke's Hospital in Kansas City, voted in favor of the drug's
safety but conceded he was "very conflicted."
"I do share the concerns about safety but I also believe,
based on some of the things we've heard from our experts and
consumers, that there probably is a strong need for a long
Analysts were not expecting the drug to receive a warm
welcome from the panel, based on the negative tone of the
initial FDA staff review.
Endo's shares closed down 0.6 percent to $35.75 on Nasdaq.