Updated Jul 21, 2007 at 23:13 EST.
Johnson & Johnson, maker of the drug
dapoxetine (
Priligy ™ ) for premature ejaculation ( PE ), hopes to try its luck with European regulators in hopes of gaining approval for the drug rejected by the FDA in 2005. Clinical studies of dapoxetine indicate that it could provide relief for premature ejaculation ( PE ) on a short-term basis. There were side effects associated with dapoxetine including reported loss of consciousness and nausea.
Company officials indicate a possible filing for European approval late in 2007. Johnson & Johnson has not released information about new clinical trials and may be planning separate trials to assist in approving the drug for American men. Since the FDA does not release information on why drugs are denied approval, company officials can only speculate. Some of the most common reasons postulated for the drug’s denial are its reported side effects and lack of recognition of premature ejaculation as a disruption in the lives of men who are affected by it.
Written by the PEhomepage.com Editorial Team.
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