Novel Antidepressant Valdoxan(R), Receives EMEA CHMP Positive Opinion For Major Depressive Episodes

Main Category: Depression
Also Included In: Psychology / Psychiatry;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 23 Nov 2008 - 1:00 PDT

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Valdoxan® today received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) for its use in the treatment of adult patients with Major Depressive Episodes (MDE).1

Valdoxan is an innovative approach to the treatment of MDE and has demonstrated convincing efficacy in depressed patients with moderate-severe depression2, offering new hope to many of the more than 2.9 million people in the UK who are diagnosed as having depression at any one time.3

Data from its clinical development programme show that Valdoxan is effective against the core symptoms of depression, including depressed mood, anxiety, psychomotor retardation, sleep disturbances, and daytime fatigue.4-8

Valdoxan, the result of an advanced pharmacological research programme involving investigation centres all around the world, is a different approach to the treatment of depression that goes a step beyond the monoamine hypothesis. Valdoxan is an MT1 & MT2 melatonergic receptor agonist with 5-HT2C receptor antagonist properties.9,10 As a result of this novel mode of action, Valdoxan has demonstrated convincing antidepressant efficacy in addition to circadian rhythm resynchronisation.11 This mechanism of action is unlike those of commonly prescribed antidepressants such as selective serotonin reuptake inhibitors (SSRIs), and serotonin and noradrenaline reuptake inhibitors (SNRIs), since Valdoxan has no impact on serotonin levels.1

In clinical trials Valdoxan has demonstrated efficacy at a once-daily dose of 25 - 50 mg in moderately and severely depressed adult patients (18-65 years old) presenting with a first or recurrent episode of Major Depressive Disorder (MDD). 2, 4 - 8, 10

Short-term and long-term results from the extensive international development programme, including nearly 4,000 adult patients with MDD, were presented to the CHMP. This programme supported the antidepressant efficacy of Valdoxan as compared with placebo, SSRI and SNRI treatments. This programme also showed that Valdoxan's antidepressant efficacy was combined with a favourable tolerability profile. Indeed, most patients treated with Valdoxan did not present with any symptoms of sexual dysfunction.7 Furthermore, in double-blind placebo controlled trials patients treated with Valdoxan exhibited a body weight variation profile similar to that of placebo.13 Finally, studies indicate that Valdoxan has beneficial effects on disturbed sleep patterns in depression as early as the first week of treatment4 and is not associated with discontinuation symptoms upon cessation of treatment.14 As a precautionary measure liver function tests will be required during treatment with Valdoxan. In clinical trials an increase in serum transaminases (an indicator of liver function) was observed in some patients. When Valdoxan was discontinued in these patients, the serum transaminases usually returned to normal levels. Incidences of liver damage or pathology were rarely reported. 15

Valdoxan® was discovered and developed by Servier, France's leading independent pharmaceutical company. Subject to approval by the European Commission it will be marketed by Servier in the UK in 2009.

Key facts about Depression in the UK

- Depression is characterised by a low mood and loss of interest, usually accompanied by one or more of the following . low energy, change in appetite, weight or sleep pattern, poor concentration, feelings of guilt or worthlessness and suicidal ideas.16

- At least one person in every six becomes depressed in the course of their lives. One in twenty is clinically depressed.17

- Major depressive disorder is increasingly seen as chronic and relapsing, resulting in high levels of personal disability, lost quality of life for patients, their family and carers, multiple morbidity, suicide, higher levels of service use and many associated economic costs.18

- In 2000, 109.7 million lost working days were attributable to depression. 18

- The total annual cost of adult depression in England has been estimated at over £9 million, of which £370 million represents direct treatment costs.18

- Depression is currently the fourth leading cause of disability and disease worldwide. The World Health Organisation estimates that by the year 2020, major depression will be second only to chronic heart disease as an international health burden (this is measured by its cause of death, disability, incapacity to work and the medical resources it uses).19

- An estimated 15% of all depressed patients eventually kill themselves.20 Depression accounted for 2,615 deaths in the UK in 2000 alone21, which is roughly seven people a day.

About Servier

- Servier Laboratories Ltd is the UK subsidiary of the Servier Research Group, the leading independent French research based pharmaceutical company established in 1954 by Dr Jacques Servier.

- Established in 140 countries, The Servier Research Group has annual sales worldwide of over 3.5 billion euros.

- The key franchises of the Servier Research Group are Cardiovascular disease, Diabetes, Rheumatology, Central Nervous System and Oncology.

- Servier is a research based company which seeks to fulfil unmet patient need.

- Servier earmarks 25% of its turnover for research and development every year, which is considerably higher than the industry average.

- Foundation status provides Servier with the opportunity to focus on the development of innovative drugs.

http://www.servier.co.uk

References

1. EMEA website http://www.emea.europa.eu/pdfs/human/opinion/Valdoxan_57541108en.pdf (Date Last Accessed: 21 November 2008)

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

3. Ohayon MM, Priest RG, Guilleminault C, et al. Biol Psychiatry. 1999; 45: 300-307

4. Lemoine P, Guilleminault C and Alvarez E. J Clin Psychiatry. 2007; 68: 1723-1732

5. Olié JP and Kasper S. Int J Neuropsychopharmacol. 2007; 10: 661-673

6. Kennedy SH and Emsley R. Eur Neuropsychopharmacol. 2006; 16(2): 93-100

7. Kennedy SH, Rizvi S, Fulton K and Rasmussen J. J Clin Psychopharmacol. 2008; 28: 329-333

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

9. Chilman-Blair K, et al. Drugs of the Future. 2003; 28(1): 7-13

10. Lôo H, Hale A and D'haenen H. Int Clin Psychopharmacol. 2002; 17: 239-247

11. Leproult R, Van Ondergergen A, L'Hermite-Balériaux M, et al. Clin Endocrinol. 2005; 63: 298-304

12. Stahl S. Int Journal of Psychopharmacol. 2007; 10: 575-578

13. Data on File 07VADOF126

14. Montgomery Kennedy SH, Burrows GD, et al. Int Clin Psychopharmacol. 2004; 19: 271-280.

15. Data on File 08VAL0094

16. NICE depression guideline, Questions and Answers Depression and Anxiety http://www.nice.org.uk/nicemedia/pdf/CG022%20and%20CG023_QandA.pdf (Date Last Accessed: 20 November 2008)

17. Mind Information Booklet: Understanding Depression. http://www.mind.org.uk/Information/Bookletes/Understanding/Understanding+depression.htm (Date Last Accessed: 20 November 2008)

18. Quality and Outcomes Framework, Revisions to the GMS Contract 2006-7 http://www.bma.org.uk/ap.nsf/Content/revisionnGMSFeb20062 (Date Last Accessed: 20 November 2008)

19. Moussavi S, Chatterji S, Verdes E, et al. Lancet. 2007; 370: 851��"858

20. Scott J. British Medical Journal. .2006; 332: 985-986

21. Thomas C and Morris S. British Journal of Psychiatry. 2003; 183: 514-519.

Source
Katie Silverwood
Reynolds-MacKenzie
130 Shaftesbury Avenue
London W1D 5EU
http://www.reynoldsmackenzie.com