GSK: GlaxoSmithKline receives first European approval for Wellbutrin XR

GlaxoSmithKline announced today that Wellbutrin XR®* (bupropion hydrochloride modified-release tablets), has been granted a marketing license in The Netherlands for the treatment of adult patients with major depressive episodes. The medicine is also considered approvable by the regulatory agencies of 21 other countries** under the Decentralised Procedure.


Wellbutrin XR is the first once-daily noradrenaline dopamine reuptake inhibitor (NDRI) approved for the treatment of Major Depressive Disorder (MDD) in Europe. 1,2,3 Uniquely targeting dopamine and noradrenaline (two chemicals in the brain known to be involved in regulating mood) to treat MDD effectively, Wellbutrin XR offers an alternative to currently available treatments, including Selective Serotonin Reuptake Inhibitors (SSRIs) / Serotonin and Noradrenaline Reuptake Inhibitors (SNRIs) which some patients are unable to tolerate due to side effects such as weight gain and sexual dysfunction. 4,5,6,7


“Wellbutrin XR is an important new medicine for doctors and patients in Europe,” comments Andrew Witty, president, GSK Pharmaceuticals, Europe. “Depression can be a crippling condition that is often difficult to treat. With its unique mode of action, Wellbutrin XR offers a real alternative to the depressed patient. We hope its profile will help patients stay on their therapy, which would address a significant unmet need in the area of antidepressants.”


Wellbutrin XR is available as a 300mg or 150mg tablet with a dose of up to 300mg once daily starting with 150mg once daily.


Nearly 13 million patients have been treated with Wellbutrin XR in the USA where it is known as Wellbutrin XL *** and was FDA approved in 2003.5


It is expected that regulatory agencies in various European countries will grant national licenses for Wellbutrin XR throughout the first quarter of 2007, and the medicine could begin to be available to patients from April 2007.


GlaxoSmithKline has an agreement with Biovail Corporation for worldwide sales and distribution of bupropion hydrochloride modified-release tablets.


The most common side effects observed in clinical trials with Wellbutrin XR were trouble sleeping, headache, dry mouth, and upset stomach (nausea and vomiting).8


There is a risk of seizure with Wellbutrin XR , which increases with higher doses. People should not use it if they have had a seizure or eating disorder, or if they abruptly stop using alcohol or sedatives. People should not take Wellbutrin XR with monoamine oxidase inihibitors (MAOIs), or medicines that contain bupropion.



* Wellbutrin XR will be the most common tradename in European countries. Other tradenames include: Elontril (several countries), Voxra (Sweden) and Wellbutrin Retard (Norway).


** Austria, Belgium, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, and Sweden.


*** While Wellbutrin XL is approved for the treatment of major depressive disorder in the United States, approved conditions of use and labeling may vary from those in European countries.



References


1. Stahl SM. Essential Psychopharmacology. 2nd ed. New York, NY: CambridgeUniversityPress; 2000.

2. Ascher JA et al. J Clin Psychiatry 1995; 56:395—401.

3. Stahl SM et al. Prim Care Companion J Clin Psychiatry 2004; 6:159—166.

4. Jefferson JW et al., J Clin Psychiatry 2006 June; 67(6):865-873.

5. GSK Data on file.

6. Thase ME et al. J Clin Pharmacol 2006; 26(5): 482-488.

7. Zajecka J. J Clin Psychiatry.2001; 62 Suppl 3:35-43.

8. GSK. Wellbutrin XR European Summary of Product Characteristics. 2007.