Agomelatine

Agomelatine (BAN, rINN; trade names Valdoxan, Melitor, Thymanax) is a melatonergic antidepressant developed by the pharmaceutical company Servier. It is marketed for the treatment of major depressive disorder, primarily for its relatively favorable side effect profile: it avoids the weight gain, sexual dysfunction, and severe withdrawal associated with the most commonly-used classes of antidepressants (SSRIs, SNRIs, tricyclics), while providing similar therapeutic benefit.

Due to its distinctive mechanism of action, agomelatine is also studied for its effects on sleep regulation. Studies report various improvements in general quality of sleep metrics, as well as specific therapeutic benefits in circadian rhythm disorders.

Agomelatine was discovered and developed by the European pharmaceutical company Servier Laboratories Ltd. Servier continued to develop the drug and conduct phase III trials in the European Union.

In March 2005, Servier submitted agomelatine to the European Medicines Agency (EMA) under the trade names Valdoxan and Thymanax. On 27 July 2006, the Committee for Medical Products for Human Use (CHMP) of the EMA recommended a refusal of the marketing authorisation. The major concern was that efficacy had not been sufficiently shown, while there were no special concerns about side effects. In September 2007, Servier submitted a new marketing application to the EMA.

In March 2006, Servier announced it had sold the rights to market agomelatine in the United States to Novartis. It was undergoing several phase III clinical trials in the US, and until October 2011 Novartis listed the drug as scheduled for submission to the FDA no earlier than 2012. However, the development for the US market was discontinued in October 2011, when the results from the last of those trials became available.

It received EMA approval for marketing in the European Union in February 2009 and TGA approval for marketing in Australia in August 2010.