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 The FDA has asked for three additional studies, two
to test the drug's interaction with other drugs, and a third to
simulate driving since nearly 10 percent of women in clinical trials
became sleepy while taking the drug, flibanserin.
Privately held Sprout said it welcomed the FDA's guidance and views
it as "a significant step" toward approving flibanserin, a
once-a-day treatment for hypoactive sexual desire disorder (HSDD).
The FDA rejected flibanserin last year saying its effects were
"modest" and did not outweigh side effects such as dizziness, nausea
and fatigue. Sprout appealed the decision, and women's groups have
been pressing the FDA to approve the product, claiming gender bias
in the drug approval process.
The FDA has approved 24 drugs to treat male sexual dysfunction, and
none for women.
On January 28 representatives from eight women's advocacy groups,
including the National Organization for Women, the Center for Health
and Gender Equity, Jewish Women International and the National
Council of Women's Organizations met with Dr. Janet Woodcock, head
of the FDA's pharmaceuticals division.
They expressed their concern that the requirements for approval for
flibanserin exceeded those required for male erectile dysfunction
drugs and that the risk versus benefit assessment seems
"inconsistent" with that applied to male drugs.
"We see this not only as an important unmet women's health issue,
but an inflection point for the agency to ensure that similar
standards are applied for drug approvals in conditions uniquely
affecting women," the group wrote in a January 30 follow-up letter
to Woodcock.
A number of members of Congress have been part of the lobbying
effort. In January, Democratic lawmakers Debbie Wasserman Schultz,
Chellie Pingree, Nita Lowey and Louise Slaughter — wrote to FDA
Commissioner Margaret Hamburg urging the agency to give "careful
review" to the flibanserin data and apply "the same standards of
consideration given to the approved drugs for men in your
risk/benefit evaluation."
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Female sexual dysfunction has been identified by the FDA as one
of several therapeutic areas that it plans to focus on as part of
its patient-focused drug development program, which aims to gather
patients' perspectives on their condition and potential treatments.
Following the FDA's original rejection of the drug, Sprout's
president, Cindy Whitehead, said that the effect the FDA considers
modest, "we see as meaningful."
"It is true that flibanserin does not cause hypersexuality, but by
that definition, modest would be what we're aiming for," she said.
Sprout said it expects to resubmit its application by the third
quarter.
(Reporting by Toni Clarke in Washington;
editing by Eric Walsh)
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