Tasimelteon Fails Phase IIb/III Study as Treatment for Major Depression
Circadian regulator no better than placebo at reducing symptoms (Jan. 31)
In a recent phase IIb/III clinical trial, monotherapy with the circadian regulator tasimelteon (Vanda Pharmaceuticals) failed to meet the primary endpoint of change from baseline in the Hamilton Depression Scale (HAMD-17) after 8 weeks of treatment compared with placebo in patients with major depressive disorder (MMD). Both tasimelteon- and placebo-treated patients showed approximately 40% reductions of their MDD symptoms from baseline.
In view of these results, the drug’s developer has decided to discontinue all activities in this indication.
The MAGELLAN trial was an 8-week, double-blind, randomized, phase IIb/III clinical study in 507 patients with MDD.
Tasimelteon is a melatonin agonist of the human MT1 and MT2 receptors, with greater specificity for MT2. The drug’s ability to reset the master body clock in the suprachiasmatic nucleus (SCN), located in the hypothalamus, results in the entrainment of the body’s melatonin and cortisol rhythms to align with the 24-hour day–night cycle. Tasimelteon is currently in phase III development for non-24 sleep–wake disorder.
Source: Vanda Pharmaceuticals; January 31, 2013.