Navigation Links
Submission of Marketing Authorisation Application for Dapoxetine in Europe
Date:12/7/2007

First Oral Pharmacologic Agent Developed for the Treatment of Premature

Ejaculation

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.

About Janssen-Cilag

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 http://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 http://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.)


'/>"/>
SOURCE Janssen-Cilag
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Emphasys Medical Announces PMA Submission for Bronchial Valve Therapy
2. MD On-Line Expands Relationship with Aetna for Direct Claim Submission
3. ISI Bolsters Data Analytics Capabilities for Complete Suite of Submissions Outsourcing Services
4. Amsterdam Molecular Therapeutics Initiates Program for Late Stage Liver Cirrhosis and Reports Strong Progress in AMT-011 With Trial Fully Recruited and European and US Submission On Track for First Half of 2008
5. State Mental Health Record Submissions Double
6. Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis
7. Omnicom Acquires Leading Healthcare Marketing Communications Firm in China
8. Innocoll Agrees the Sale of its CollaRx(R) GENTAMICIN SURGICAL IMPLANT and European Sales and Marketing Infrastructure to EUSA Pharma
9. Crdentias VP of Marketing, Christina Hogan, Provides Exclusive Interview on Marketing Strategy
10. Fitness Champion Natalie Waples to be Spokesperson for Natural Nutrition International Direct Marketing Campaign
11. Roy Jakobs Appointed Elsevier Managing Director, A&G Sales and Customer Marketing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... people are unfamiliar with. The article goes on to state that individuals are now ... of these less common operations such as calf and cheek reduction. The Los Angeles ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World ... with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the ...
(Date:6/24/2016)... ... June 24, 2016 , ... The ... in Dallas that it will receive two significant new grants to support its ... PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists for ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, an ... Dr. Cheng has extensive experience with all areas of orthodontics, including robotic Suresmile ... orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, ... minimum wage raise to $12 an hour by 2020 and then adjusting it yearly to ... value of the minimum wage, assure the wage floor does not erode again, and make ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , , , WHEN: ... , , , , LOCATION: , , , Online, with ... , EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice ... Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... industry is witnessing an exceptional era. Several new demand spaces, such ...
(Date:6/23/2016)... , June 23, 2016 ... Oticon , industry leaders in advanced ... launch of Oticon Opn ™, the world,s first ... of possibilities for IoT devices.      (Photo: ... Oticon introduces a number of ,world firsts,: ...
(Date:6/23/2016)... 23, 2016 Research and Markets ... Volumes: Global Analysis (United States, China, Japan, Brazil, United ... to their offering. ... healthcare business planners, provides surgical procedure volume data in ... with an in-depth analysis of growth drivers and inhibitors, ...
Breaking Medicine Technology: