The randomized, double-blind study will compare the efficacy and safety of Labopharm’s once-daily formulation of trazodone to placebo in patients with major unipolar depressive disorder. The trial, which has a treatment period of approximately two months, is being conducted at more than 35 centers across the US and Canada and is expected to include more than 350 subjects.
Labopharm expects to submit a new drug application for trazodone under FDA rules which allow companies submitting reformulations of drugs that are already approved and being marketed to leverage existing efficacy and safety data. Under the rules, one positive phase III study is required for the formulation to be approved by the FDA.
Pilot pharmacokinetic trials have demonstrated that Labopharm’s once-daily formulation of trazodone has controlled-release properties over a 24-hour period.
James Howard-Tripp, president and CEO of Labopharm, said: “Insomnia and agitation may be associated with depression. In addition to its anti-depressive effects, trazodone has sedative effects that can improve sleep.
“Our once-daily formulation has been specifically designed to take advantage of trazodone’s unique pharmacological properties, in addition to offering the benefits of once-daily administration and potentially fewer side effects generally associated with peak concentrations of drugs. As a once-a-day product, we believe our formulation of trazodone has the potential to provide a novel approach to treating major unipolar depression.”