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FDA Rejects J&J's Dapoxetine
Posted on 2005-10-27 09:22:00
Alza Corporation, a unit of Johnson & Johnson has received a not approvable letter from the U.S. Food and Drug Administration (FDA) on its New Drug Application for dapoxetine hydrochloride, an investigational compound for the treatment of premature ejaculation (PE).
Alza Corporation is committed to developing safe and effective medicines that address important unmet medical needs. The company continues to believe that dapoxetine provides important benefits for men who suffer from PE. Alza Corporation plans to address questions raised in the FDA letter and continue the global development program.
PE is a distinct medical condition that has been recognized by the American Urological Association (AUA), the American Psychiatric Association (APA) and the World Health Organization (WHO). PE can have a significant impact on many aspects of a man's life, including his and his partner's sexual satisfaction, the ability to build and maintain relationships and a general sense of confidence. Currently, there are no drugs approved by the FDA for the treatment of PE. Traditional methods of PE treatment rely heavily on behavioral therapy and/or off-label use of older drugs that are approved for other conditions, all of which yield limited success.
Alza Corporation, headquartered in Mountain View, CA, is leading the next generation of drug delivery, with the world's broadest array of technology platforms, including oral, transdermal, implantable and liposomal technologies. More than 30 products marketed in over 80 countries worldwide now incorporate ALZA Corporation's drug delivery technologies.
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