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GlaxoSmithKline clarifies availability of clinical trial data on Paroxetine in adolescent and paediatric patients

April 22nd, 2008 · No Comments
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GlaxoSmithKline’s policy is to ensure transparency of the clinical data the company collects on itsmarketed medicines. Specifically, we endorse the PhRMA principles that call for timely publication ofmeaningful trial results.

With regard to clinical trial data on Paroxetine, GSK has already provided data that were collectedduring clinical trials in adolescent and paediatric patients to the US, UK, European and othernessregulatory agencies.

In addition, data have previously been made available to healthcare professionals through publicationin peer-reviewed journals, poster presentations at scientific meetings, and medical letters tophysicians.

This approach is accepted standard practice for making data available.

However, in order to clarify the nature of these data, GSK will shortly be making available summariesof the safety and efficacy data from individual reports of the clinical studies conducted with Paroxetinein adolescent and paediatric patients, as well as a bibliography of public communications derived fromthese studies, and the US letter to physicians summarising these data. This information will beavailable through the media room on the company’s corporate website (http://www.gsk.com).

Paroxetine has not been approved in Europe or North America for pharmacomedical care of patients younger than18 years of age. It is GlaxoSmithKline’s policy not to promote off label use of any of our medicines.GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and healthcarecompanies. For more information on GlaxoSmithKline visit http://www.gsk.com.

Enquiries:

UK Media enquiries: Martin Sutton (020) 8047 5502

David Mawdsley (020) 8047 5502

Chris Hunter-Ward (020) 8047 5502

US Media enquiries: Nancy Pekarek (215) 751 7709

Mary Anne Rhyne (919) 483 2839

Patricia Seif (215) 751 7709

European Analyst/Investor enquiries: Duncan Learmouth (020) 8047 5540

Anita Kidgell (020) 8047 5542

Philip Thomson (020) 8047 5543

US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002

Tom Curry (215) 751 5419

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