FDA Rejects PPD, Inc. And Johnson & Johnson's Premature Ejaculation Drug
WILMINGTON, N.C., Oct. 26 /PRNewswire-FirstCall/ -- PPD, Inc. today announced that ALZA Corporation issued a press release reporting that it has received a not approvable letter from the U. S. Food and Drug Administration (FDA) on their new drug application for dapoxetine hydrochloride, an investigational compound for the treatment of premature ejaculation (PE). In its release, ALZA stated that it plans to address questions raised in the FDA letter and continue the global development program.
ALZA Corporation further stated that it believes that dapoxetine provides important benefits for men who suffer from PE. 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.
PPD is a leading global contract research organization providing discovery and development services, market development expertise and compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 28 countries and more than 7,800 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients. For more information, visit our Web site at www.ppdi.com.
Except for historical information, all of the statements, expectations and assumptions, including expectations and assumptions regarding PPD's compound partnering strategy, contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making those 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 results to differ materially include the following: risks associated with the development and commercialization of drugs, including regulatory approvals, dependence on collaborative relationships; rapid technological advances that make our products and services less competitive; economic conditions and outsourcing trends in the pharmaceutical, biotechnology and medical device industries and government sector; loss of large contracts; competition within the outsourcing industry; continued success in sales growth; the ability to attract and retain key personnel; risks associated with acquisitions and investments; and the other risk factors set forth from time to time in the SEC filings for PPD, copies of which are available free of charge upon request from the PPD investor relations department.PPD, Inc.
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