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Johnson & Johnson will seek approval around the world
The Food and Drug Administration is reviewing an application for dapoxetine, which was developed
by Ortho-McNeil Pharmaceutical, an affiliate of Johnson & Johnson.
A spokesman for the above pharmaceutical developer said the company had not decided whether
to make similar applications to European regulators.
Chemically, Dapoxetine is similar to a family of antidepressants called selective serotonin reuptake inhibitors (SSRIs).
It targets premature ejaculation, one of those hidden conditions that can cause terrible problems in a relationship
and a great deal of embarrassment
Trials of dapoxetine have joined 2,614 men aged 18-77 with premature ejaculation, who maintained monogamous
sexual relationships for more than half of year. Each subject received 30mg or 60mg of dapoxetine or a dummy pill
over 12 weeks.
Dapoxetine hydrochloride had a big impact on ejaculation. It trebled the duration of intercourse. This beneficial effect occurred
after the first dose and increased over the study period.
Currently, this new drug Dapoxetine, is undergoing Phase III clinical evaluation. Following successful regulatory
approval, dapoxetine will be marketed by Ortho-McNeil Pharmaceutical, Inc. in the USA, Janssen-Ortho Inc.
in Canada and by Janssen-Cilag companies around the world.
Johnson & Johnson Pharmaceutical Research & Development, are developing dapoxetine hydrochloride and will seek approval
from regulatory authorities around the world.
Probbably The US drug approval agency will give green light next year, in January 2006
If approved by the FDA, dapoxetine hydrochloride would be the first prescription treatment designed specifically to treat premature ejaculation
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