Janssen-Cilag Release: Submission of Marketing Authorization Application for Dapoxetine in Europe
Published: Dec 07, 2007
STOCKHOLM, Sweden, Dec. 7 /PRNewswire/ -- Janssen-Cilag companies in Europe have submitted a Marketing Authorisation Application (MAA) for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age.
Premature ejaculation is a form of male sexual dysfunction associated with marked distress and interpersonal difficulty caused by persistent or recurrent undesired ejaculation with minimal sexual stimulation before, during or shortly after penetration.
The MAA for dapoxetine was submitted under the decentralised procedure, in which Sweden will act as the Reference Member State and Austria, Finland, Germany, Italy, Portugal and Spain will act as the Concerned Member States for the application. Regulatory submissions in other regions of the world are expected to follow.
Dapoxetine is the first oral pharmacologic agent developed specifically for the treatment of men with PE. The safety and efficacy of dapoxetine for the treatment of men with PE were studied in five, double-blind, placebo- controlled, Phase III clinical trials involving over 6,000 subjects from 30 countries worldwide, including countries in North America, South America, Europe and Asia, and in Israel and South Africa.
Results of all randomised studies were consistent, and improvements included both increases in average intravaginal ejaculatory latency time (IELT) and improved patient-reported outcomes of increased control over ejaculation and reduced personal distress related to ejaculation. The most common adverse drug reactions reported during clinical trials were headache, dizziness, nausea, diarrhea, insomnia and fatigue.
Dapoxetine is licensed from PPD, Inc.
The Janssen-Cilag companies are part of the Johnson & Johnson family of companies. Janssen-Cilag companies have a long track record in developing and marketing treatments for central nervous system disorders, pain management, oncology, infectious diseases, reproductive health and gastrointestinal disorders. More information about Janssen-Cilag can be found at www.janssen-cilag.com.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Janssen-Cilag companies' expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov or on request from Johnson & Johnson. The Janssen-Cilag companies do not undertake to update any forward- looking statements as a result of new information or future events or developments.)
CONTACT: Investor Relations, Louise Mehrotra, +1-732-524-6491, or Lesley
Fishman, +1-732-524-3922; US Media, Samina Bari, +1-908-218-6483; European
Media, Siegfried Marynissen, +32 14 60 54 09
Web site: http://www.janssen-cilag.com/