Navigation Links
Valdoxan(R) Granted Marketing Authorisation for the Treatment of Major Depressive Episodes in Europe
Date:2/24/2009

PARIS, January 24 /PRNewswire/ -- The European Commission has granted marketing authorisation for Servier's Valdoxan(R) /Thymanax(R) (agomelatine), the first melatonergic antidepressant for the treatment of adult patients with major depressive episodes.

"There is still great scope for improved therapies to treat the devastating effects of depression," said Professor Goodwin from Warneford Hospital, Oxford, United Kingdom. "Valdoxan is an innovative, new approach to the management of depression that compares favourably to existing treatments. It has proven, sustained efficacy across a wide range of depressed patients, including those who are most severely depressed."

Valdoxan, one 25 mg tablet taken at bedtime, offers new hope for the 33 million people in Europe suffering from major depressive episode. Valdoxan's powerful antidepressant efficacy combined with its good safety and tolerability profile is a result of its unique receptor profile. Valdoxan is the first antidepressant with melatonin receptor (MT1) and (MT2) agonist properties and 5-hydroxytryptamine (serotonin) receptor 2C (5-HT2C) antagonist properties. This unique receptor profile of Valdoxan allows for the first time the restoration of the circadian rhythms of depressed patients.(1)

Valdoxan: significant antidepressant efficacy from the start to the end of treatment

The European approval of Valdoxan is based on both short and long-term results from a large, comprehensive, international development programme including almost 6,000 adult patients with depression. The results demonstrate the superior efficacy of Valdoxan as compared with placebo, selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitor (SNRI) treatments and also show that:

    - Valdoxan has proven efficacy whatever the intensity of symptoms, in
      moderately and severely depressed adult patients (18-65 years old)
      presenting a first or recurrent episode of depression(2)

    - Valdoxan has demonstrated efficacy at every step of depression
      treatment, showing superior clinical improvement within the first week
      of treatment, as reported by both physicians and patients(3),(4)

    - Valdoxan is effective against all the core symptoms of depression,
      including depressed mood, anxiety, feeling of guilt, psychomotor
      retardation, sleep disturbances, and daytime fatigue, leading depressed
      patients to a more complete and sustained remission(5)

    - Valdoxan has been proven to significantly reduce the incidence of
      relapse in depressive patients over the long term(4)

    - Valdoxan preserves sexual functioning, is weight neutral and offers a
      favourable tolerability profile, thus resulting in better adherence and
      remission in depressed patients(6)

    - Valdoxan is easy to use from beginning to end: a simple dose of one 25
      mg tablet taken orally at bedtime, without discontinuation symptoms at
      the end of treatment.(7)

"Valdoxan has the potential to relieve the symptoms of depression with a reduced risk of significant adverse effects," said Professor Goodwin. "With noticeable clinical improvement as early as the first week of treatment, Valdoxan represents an advance for depressed patients who today expect a more complete remission."

Valdoxan: a major therapeutic advance in management of depression through the restoration of circadian rhythms

Valdoxan is the result of an advanced pharmacological research programme involving investigation centres all around the world. It is the first antidepressant that simultaneously acts as a MT1 and MT2 melatonergic receptors agonist and a 5-HT2C antagonist. As a result, Valdoxan resynchronises circadian rhythms that are profoundly disrupted in depressed patients.(8)

"Valdoxan's mechanism of action is unlike those of the commonly-prescribed antidepressants, the SSRIs and SNRIs, as Valdoxan exerts its antidepressant efficacy without having an impact on serotonin levels," pointed out Professor Racagni from the University of Milan, Italy.

The recommended dose of Valdoxan is one tablet of 25 mg taken once daily, orally at bedtime.

Following approval from the European Commission, Valdoxan is expected to become commercially available in European countries in the coming months.

Valdoxan(R) was discovered and developed by Servier, France's leading independent pharmaceutical company.

References

(1) Lôo H, Hale A, D'haenen H. Int Clin Psychopharmacol. 2002;17:239-247.

(2) Montgomery SA, Kasper S. Int Clin Psychopharmacol. 2007;22:283-291

(3) Kasper S, Laigle L, Baylé F. Eur Neuropsychopharmacol. 2008;18(suppl4):S336.Abstract P2c022.

(4) Goodwin G, Rouillon F, Emsley R. Eur Neuropsychopharmacol. 2008;18(suppl4):S338. Abstract P2c025.

(5) Lemoine P, Guilleminault C, Alvarez E. J Clin Psychiatry. 2007;68:1723-1732.

(6) Kennedy SH, Rizvi S, Fulton K, Rasmussen J. J Clin Psychopharmacol. 2008;28:329-333.

(7) Montgomery SA, Kennedy SH, Burrows GD, Lejoyeux M, Hindmarch I. Int Clin Psychopharmacol. 2004;19:271-280

(8) Leproult R, Van Ondergergen A, L'Hermite-Balériaux M, Van Cautert E, Copinschi G. Clin Endocrinol. 2005;63:298-304.


'/>"/>
SOURCE Servier
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Odyssey Thera Granted U.S. Patent for Novel GPCR Assay Strategy
2. GeneNews granted U.S. patent for Chagas disease based on Sentinel Principle(TM) platform
3. BioLife Solutions Granted European Biopreservation Patent
4. ScinoPharm Granted US Patent for Novel Crystal Forms
5. Memory Pharmaceuticals Granted Extension to Comply with NASDAQ Listing Requirements
6. MonoSol Rx Granted Strategic US Patent for Thin Film Manufacturing Process
7. Autonomy(TM) Lapro-Angle(TM) Articulating Laparoscopic Instruments Granted CE Mark
8. Wyeths Motion to Overturn Punitive Damages Award Granted by Arkansas Court
9. Biopure Granted Additional 180 Day Compliance Period by NASDAQ
10. Skinvisible Patent Granted in Australia
11. Eisai is Granted Favorable Preliminary Injunction Ruling in Aricept(R) Patent Infringement Lawsuit Against Teva Pharmaceuticals
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... October 12, 2017 , ... They call it ... biological network, a depiction of a system of linkages and connections so complex ... associate professor of computer science at Worcester Polytechnic Institute (WPI) and director of ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... pharmaceutical and biotechnology industries to improve patient outcomes and quality of life, will ... analytical testing are being attributed to new regulatory requirements for all new drug ...
(Date:10/11/2017)... ... October 11, 2017 , ... ComplianceOnline’s Medical Device Summit is back for its ... 2018 in San Francisco, CA. The Summit brings together current and former FDA office ... directors and government officials from around the world to address key issues in device ...
(Date:10/11/2017)... , ... October 11, 2017 , ... ... the implantation and pregnancy rates in frozen and fresh in vitro fertilization ... progesterone and maternal age to IVF success. , After comparing the results from ...
Breaking Biology Technology:
(Date:5/16/2017)... , May 16, 2017  Veratad Technologies, LLC ( ... online age and identity verification solutions, announced today they ... Conference 2017, May 15 thru May 17, 2017, in ... and International Trade Center. Identity impacts ... and in today,s quickly evolving digital world, defining identity ...
(Date:4/18/2017)... a global expert in SoC-based imaging and computing solutions, has developed ... the company,s hybrid codec technology. A demonstration utilizing TeraFaces ® , ... showcased during the upcoming Medtec Japan at Tokyo Big Sight April ... Vegas Convention Center April 24-27. ... Click here for an image of the M820 ...
(Date:4/11/2017)... , Apr. 11, 2017 Research and Markets ... 2017-2021" report to their offering. ... The global eye tracking market to grow at a CAGR ... Global Eye Tracking Market 2017-2021, has been prepared based on an ... the market landscape and its growth prospects over the coming years. ...
Breaking Biology News(10 mins):