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 The U.S. Food and Drug Administration said the pink pill, to be sold
under the brand name Addyi and made by privately held Sprout
Pharmaceuticals, will only be available through certified and
specially trained health care professionals and pharmacies due to
its safety issues.
Addyi, whose chemical name is flibanserin, is designed for
premenopausal women whose lack of sexual desire causes distress. The
condition is formally known as hypoactive sexual desire disorder, or
HSDD. The drug needs to be taken daily.
Addyi has been nicknamed the "female Viagra" even though it does not
work like Pfizer Inc's blockbuster Viagra pill for men that in 1998
became the first approved drug for erectile dysfunction.
"This is the biggest breakthrough in women's sexual health since the
advent of 'the Pill'" for contraception, The National Consumers
League said in a statement. "It validates (and) legitimizes female
sexuality as an important component of health."
But Public Citizen, a consumer watchdog group that testified against
the drug earlier this year, predicted that Addyi will be pulled from
the market within a few years because of "serious dangers to women,
with little benefit" to them. "Unfortunately, we haven't heard the
last of this drug."
The FDA had twice rejected the Raleigh, North Carolina-based firm's
drug. But the latest decision comes after an advisory panel
concluded in June it should be approved with strict measures in
place to ensure patients are fully aware of the risks.
Sprout officials could not immediately be reached for comment
The news sent shares of Palatin Technologies, which is creating a
rival drug for HSDD, up about 30 percent to $1.21 in extended trade.
Palatin's experimental treatment called bremelanotide is now in
late-stage trials and works differently from Addyi. It attempts to
activate certain brain pathways.
Palatin in a statement late Tuesday said its drug, if approved,
would only be taken as needed, not on a daily basis like Addyi,
thereby providing women "greater control and flexibility in their
treatment."
Unlike Viagra, which affects blood flow to the genitals, Addyi is
meant to activate sexual impulses in the brain. It is similar to a
class of other drugs known as selective serotonin reuptake
inhibitors, or SSRI's, that include antidepressants such as Prozac.
Women who took Addyi in a clinical study had an increase of about
one sexually satisfying event per month compared with those taking a
placebo. Advocates claim that increase is meaningful. Critics say
the small benefit is outweighed by the drug’s risks.
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SEVERE SIDE EFFECTS
Addyi will come with a prominent "boxed warning" about side effects,
including among people with liver impairment or who take Addyi with
alcohol or with medicines known as CYP3A4 inhibitors that include
certain steroids.
Originally developed by Germany's Boehringer Ingelheim under its
chemical name flibanserin, it was first rejected by the FDA in 2010
after an advisory panel said the benefits did not outweigh the
risks. Sprout acquired the drug, conducted additional studies and
resubmitted the application. In 2013, the FDA rejected it again.
The rejection sparked a lobbying campaign by Sprout, aided by some
women's groups who accused the FDA of gender bias because it had
approved Viagra for men - a charge the FDA vigorously rejected.
The FDA approved Addyi despite a rocky relationship in recent years
with the founders of Sprout.
The chief executive of Sprout, Cindy Whitehead, co-founded the
company with her husband Robert Whitehead in 2011 after selling
another small drugmaker they had founded called Slate
Pharmaceuticals which had received repeated warnings from the FDA
about its marketing tactics.
Slate marketed an implantable testosterone pellet for men with low
levels of the male sexual hormone, called Testopel.
In one FDA warning letter, issued on March 24, 2010, the FDA said
Slate had improperly inferred on its Testopel website and in a video
that the testosterone product could help patients with depression,
erectile dysfunction, diabetes and HIV.
The Whiteheads could not be reached for comment late on Tuesday
about Addyi's approval and their earlier encounters with the FDA.
(Additional reporting by Toni Clarke in Washington; Editing by
Bernard Orr)
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