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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.


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