FDA Approves Stendra For Erectile Dysfunction
April 27 2012 - 2:44PM
Dow Jones News
The Food and Drug Administration Friday approved a new drug from
Vivus Inc. (VVUS) to treat erectile dysfunction.
The approval of the drug, Stendra, is the first product approval
for Vivus, based in Mountain View, Calif. The company is also
awaiting an FDA decision on its proposed obesity drug Qnexa, which
is expected about July 17.
Stendra is also known by its generic name avanafil. The drug
falls into the same class as other erectile dysfunction treatments
on the market such as Pfizer Inc.'s (PFE) Viagra and Eli Lilly
& Co.'s (LLY) Cialis. The drugs work by increasing blood flow
to the penis.
Erectile dysfunction is when a man has trouble getting or
keeping an erection. An estimated 30 million men in the United
States are affected by erectile dysfunction, the FDA said.
Stendra is a pill that patients take on an as-needed basis 30
minutes before sexual activity.
The agency said Stendra, like Cialis and Viagra, should not be
taken by men who take nitrates for chest pain because the
combination of the two drug can cause an unsafe drop in blood
pressure. The FDA also said Stendra and the other ED drugs, which
are called PDE5 inhibitors, can cause color vision changes. Some
men taking PDE5 inhibitors have reported a sudden loss of vision in
one or both eyes or a sudden loss or decrease in hearing.
The FDA said the most common side effects reported in clinical
studies of Stendra included headache, redness of the face and other
areas, or flushing, nasal congestion and back pain. The drug's
approval was based on three clinical studies that involved 1,267
patients for 12 weeks. A subset of patients were followed for up to
an additional 40 weeks to evaluate potential safety problems.
-By Jennifer Corbett Dooren; Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
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