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| FILE - In this June 22, 2015, photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters. The Food and Drug Administration on Tuesday, Aug. 18, 2015, approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men. |
WASHINGTON
(AP) -- The Food and Drug Administration on Tuesday approved the first
prescription drug designed to boost sexual desire in women, a milestone
long sought by a pharmaceutical industry eager to replicate the
blockbuster success of impotence drugs for men.
But
stringent safety measures on the daily pill called Addyi mean it will
probably never achieve the sales of Viagra, which has generated billions
of dollars since the late 1990s.
The drug's
label will bear a boxed warning - the most serious type - alerting
doctors and patients to the risks of dangerously low blood pressure and
fainting, especially when the pill is combined with alcohol. The same
problems can occur when taking the drug with other commonly prescribed
medications, including antifungals used to treat yeast infections.
"Patients
and prescribers should fully understand the risks associated with the
use of Addyi before considering treatment," said Dr. Janet Woodcock,
director of the FDA's drug center, in a statement.
Under
an FDA-imposed safety plan, doctors will only be able to prescribe
Addyi after completing an online certification process that requires
counseling patients about Addyi's risks. Pharmacists will also need
certification and will be required to remind patients not to drink
alcohol while taking the drug.
Opponents of
the drug say it's not worth the side effects, which also include nausea,
drowsiness and dizziness. They point out that the FDA rejected the drug
twice, in 2010 and 2013, due to these risks.
"This
is not a drug you take an hour before you have sex. You have to take it
for weeks and months in order to see any benefit at all," said Leonore
Tiefer, a psychologist and sex therapist who organized a petition last
month calling on the FDA to reject the drug.
Patients should stop taking the drug after eight weeks if they do not see any improvement, notes the FDA release.
Sprout
Pharmaceutical's drug is intended to treat women who report emotional
stress due to a lack of libido. Its approval marks a turnaround for the
FDA, which previously rejected the drug twice due to lackluster
effectiveness and side effects. The decision represents a compromise of
sorts between two camps that have publicly feuded over the drug for
years.
On one side, Sprout and its supporters
have argued that women desperately need FDA-approved medicines to treat
sexual problems. On the other side, safety advocates and pharmaceutical
critics warn that Addyi is a problem-prone drug for a questionable
medical condition.
Beginning with the drug's
launch in mid-October, doctors who see patients complaining about a loss
of sexual appetite will have a new option.
"Women
are grasping, and I feel like we need to offer them something that
acknowledges that, and that we can feel safe and comfortable with," said
Dr. Cheryl Iglesia, a surgeon and official with the American Congress
of Obstetricians and Gynecologists. Iglesia said she has occasionally
resorted to prescribing testosterone creams to boost women's libido, a
use not approved by the FDA.
The search for a
pill to treat women's sexual difficulties has been something of a holy
grail for the pharmaceutical industry. It was pursued and later
abandoned by Pfizer, Bayer and Procter & Gamble, among others. But
drugs that act on blood flow, hormones and other biological functions
all proved ineffective.
Addyi, known generically as flibanserin, is the first drug that acts on brain chemicals that affect mood and appetite.
Women
and their doctors will have to decide whether the drug's modest
benefits warrant taking a psychiatric pill on a daily basis.
Company
trials showed women taking the drug generally reported one extra
"sexually satisfying event" per month, and scored higher on
questionnaires measuring desire.
Tiefer and
other critics said the FDA was pressured into approving the drug by a
feminist-themed lobbying campaign funded by Sprout and other drugmakers.
"It's just a mishmash of politics and science and sex and money," Tiefer said.
The
lobbying group, dubbed Even the Score, began publicizing the lack of
drugs for female sexual dysfunction as a women's rights issue last year.
"Women
deserve equal treatment when it comes to sex," the group states in an
online petition to the FDA, which attracted more than 60,000 supporters.
Women's groups, including the National Organization for Women, signed
on to the effort, though it was funded by Sprout and other companies
working on female sex drugs.
At an FDA meeting
in June, more than 30 members of the public called for the drug's
approval, frequently citing the Even the Score campaign. They vastly
outnumbered speakers who spoke in opposition to the drug. At the
meeting's conclusion, the panel of FDA advisers voted 18-6 to recommend
approving the drug, with safety restrictions.
Sprout declined to comment on how much it spent on the campaign.
For
now, executives with the Raleigh, North Carolina-based company are
setting modest expectations for Addyi, their first and only product. The
company will focus its 200 sales representatives on promoting the drug
to medical specialists.
"We will be small,"
CEO Cindy Whitehead said. "We will be specialty focused among the
physicians who already have a familiarity with female sexual
dysfunction."
Women with insurance can expect to pay between $30 and $75 per month for Addyi, depending on the terms of their coverage.
The
FDA specifically approved the drug for premenopausal women with
hypoactive sexual desire disorder, a lack of sexual appetite that causes
distress.
Surveys estimate that 8 to 14
percent of women ages 20 to 49 have the condition, or about 5.5 to 8.6
million U.S. women. Because so many factors affect sexual appetite,
there are a number of alternate causes doctors must rule out before
diagnosing the condition, including relationship issues, medical
problems, depression and mood disorders.
The
diagnosis is not universally accepted, and some psychologists argue that
low sex drive should not be considered a medical problem.
