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 The U.S. Food and Drug Administration late on Tuesday approved the
drug, called Addyi, for pre-menopausal women. The agency had
previously rejected the treatment twice over concerns it did not
provide a significant enough benefit to outweigh its risks, but came
under pressure from advocacy groups who argued that women were
unfairly denied access to the therapy.
When Addyi is introduced in mid-October by privately held Sprout
Pharmaceuticals, it will carry strong warnings that it can cause
severely low blood pressure and fainting, especially when used with
alcohol, and pose serious risk to those with liver impairment or who
take a class of drugs that include some steroids. It must be taken
daily.
The dangers will likely deter many women since Addyi in clinical
trials was associated with an increase of only one sexually
satisfying sexual event per month, said Raghuram Selvaraju, managing
director of brokerage H.C. Wainwright & Co.
"This drug is not going to provide a dramatic or meaningful
improvement to a woman's sex life, so why would you take it with all
these side effects?" said Selvaraju, who predicted Addyi will
achieve peak annual U.S. sales of $100 million.
That's a far cry from the $1.3 billion in annual U.S. sales for
Viagra, Pfizer's erectile dysfunction drug that was approved in 1998
and has blazed the path for lucrative rivals, including Eli Lilly
and Co's Cialis.
There will be some pent-up demand for Addyi for perhaps six months,
but then patients and doctors will abandon the drug as side effects
pile up, Selvaraju predicted.
"When all is said and done, revenues from Addyi may wind up barely
covering the costs of developing it," he said.
Len Yaffe, managing director of healthcare hedge fund Kessef Capital
Management, predicts Addyi's side effects and slight efficacy will
prevent its annual sales from topping $300 million.
"I don't expect it to become a Viagra for women," he said. "The most
important thing is that it will open the door for approval of other
drugs" to treat the condition, formally known as hypoactive sexual
desire disorder (HSDD). Sprout estimates that up to 10 percent of
U.S. women have the condition.
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The price of Addyi has not been announced, but company officials on
Wednesday said insurers are likely to require monthly co-payments of
about $30 to $75, similar to those for Viagra.
An experimental treatment from Palatin Technologies, called
bremelanotide, acts more quickly than Addyi. Like Viagra, it is
taken only as needed and has been well tolerated, and it could
capture up to $1 billion in annual sales if successful in ongoing
late-stage trials, Yaffe said. That prospect could prompt a large
drugmaker to buy Palatin or license its drug, he added.
Sprout executives said they plan to expand the market for Addyi by
seeking approval outside the United States, but declined to
speculate when. Having already studied Addyi in postmenopausal
women, a potentially larger market, the company said it expects to
seek approval for that indication in the future.
Dr. Rebecca Zucconi, a gynecologist and assistant professor at
Quinnipiac University, said Addyi, while not a highly impressive
drug, provides an alternative to the counseling and psychotherapy
that have been a mainstay of treatment for women with low sexual
desire.
"Hopefully we'll have several other options down the road" for
women, she said. Addyi “is the first, and if it opens up the
conversation, that's a good thing."
(Reporting by Ransdell Pierson; Editing by Bernard Orr)
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