Furiex Announces that the European Commission Endorses Positive Opinion of Priligy™ for the On-Demand Treatment of Prematur...
01 February 2012 - 8:05AM
Business Wire
Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) today announced that
the European Commission endorsed the positive opinion adopted by
the Committee for Human Medicinal Products (CHMP) on October 18,
2011 for Priligy™ (dapoxetine) 30 mg and 60 mg doses. Pending
national approvals, the marketing authorization for the Priligy
doses can be granted in the European Union Member States where the
drug has not yet been approved, and also in Norway and Iceland. The
indication for Priligy approved by the EC is the on-demand
treatment of premature ejaculation in men between the ages of 18
and 64.
“We are pleased with the decision of the European Commission,”
said June Almenoff, M.D., Ph.D., president and chief medical
officer of Furiex. “This decision will make Priligy, the only
approved medication for premature ejaculation, available to a wider
market in the EU.”
About Premature Ejaculation
Premature ejaculation (PE) is a distressing sexual dysfunction
that can be present from the first sexual encounter or can develop
later in life. The condition consists of three major components: a
short time to ejaculation, lack of ejaculatory control, and
negative personal impact, including distress related to rapid
ejaculation. A combination of physiological and psychological
factors is believed to influence the mechanism of ejaculation.
Research suggests serotonin plays a central role in the timing of
ejaculation.
About Priligy
Priligy (dapoxetine) is a unique, short-acting, selective
serotonin reuptake inhibitor (SSRI) designed to be taken only when
needed – one to three hours before sexual intercourse is
anticipated – rather than every day. The drug is specifically
developed for the on-demand treatment of PE and was extensively
evaluated in five randomized, placebo-controlled Phase III clinical
trials involving more than 6,000 men with PE and their partners.
This is the largest and most comprehensive clinical trial program
to date for a drug therapy to treat PE. Priligy is the first oral
medication (tablet) to be approved for this condition in a growing
number of countries around the world. Priligy is marketed by
Janssen-Cilag, a division of Johnson & Johnson.
About Furiex
Furiex Pharmaceuticals is a drug development collaboration
company that uses innovative clinical development design to
accelerate and increase value of internal and partnered drug
programs by advancing them through the drug discovery and
development process in a cost-efficient manner. Development
programs are designed and driven by a core team with extensive drug
development experience. The company collaborates with
pharmaceutical and biotechnology companies and has a strong,
diversified product portfolio and pipeline with multiple
therapeutic candidates including late-stage assets and two products
on the market. The company’s mission is to develop innovative
medicines faster and at a lower cost, thereby improving
profitability and accelerating time to market while providing
life-improving therapies for patients. For more information, visit
www.furiex.com.
Except for historical information, all of the statements,
expectations and assumptions contained in this news release are
forward-looking statements that involve a number of risks and
uncertainties. Although Furiex attempts to be accurate in making
these forward-looking statements, it is possible that future
circumstances might differ from the assumptions on which such
statements are based. In addition, other important factors which
could cause actual results to differ materially include the
following: failure of our partner to successfully obtain regulatory
approval to market and sell its product in the individual EU
countries; time required to gain regulatory approvals; the demand
for our potential products, if and when approved; the risks and
expense of continuing the research and development activities of
dapoxetine; the progress of Priligy in commercialization as it
relates to receiving future milestone and royalty payments; and the
other risk factors set forth from time to time in the SEC filings
for Furiex, copies of which can be found on our website.
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