The European Commission granted marketing authorization for Servier's Valdoxan, reportedly the first melatonergic treatment for adults suffering from major depressive episodes. Valdoxan is expected to become available in the coming months, says the company.
Valdoxan manages depression through the restoration of circadian rhythms and simultaneously acts as a MT1 and MT2 receptor agonist and a 5-HT2C antagonist.
"Valdoxan has the potential to relieve the symptoms of depression with a reduced risk of significant adverse effects," says Guy Goodwin, who has received research funding from the company and is a professor of psychiatry at the University of Oxford. "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."
Results from an international study including nearly 6,000 adults with depression found Valdoxan was effective in all intensities of depressive symptoms and showed improvement in patients within the first week of treatment, says the company. The drug reduced the incidence of relapse in long-term patients and preserved sexual functioning as well as offering a favorable tolerability profile, it adds.