Methods of providing weight loss therapy in patients with major depression

Inventors

Dunayevich, Eduardo • Tollefson, Gary

Assignees

Nalpropion Pharmaceuticals LLC

Abstract

Disclosed are methods of providing weight loss therapy, particularly for patients suffering from major depression.

Core Innovation

The invention provides weight loss therapy for an overweight or obese patient suffering from major depressive disorder. The method comprises administering naltrexone or a pharmaceutically acceptable salt thereof in a range of about 4 mg to about 50 mg per day and bupropion or a pharmaceutically acceptable salt thereof in a range of about 30 mg to about 500 mg per day.

The method is characterized in that it provides about the same amount of weight loss in overweight or obese patients who are suffering from major depressive disorder as in overweight or obese patients who are not suffering from major depressive disorder. The disclosure includes sustained release formulations and specific daily amounts, including about 32 mg per day of naltrexone and about 360 mg per day of bupropion.

In described embodiments, the therapy is delivered as a single oral dosage form and once per day. The disclosure further relates to relative dosing order of administering naltrexone before or after bupropion, and to a weekly dosing schedule that increases naltrexone and escalates bupropion over week one to week four and thereafter.

Claims Coverage

The partial content contains two independent claims. Across these claims, the key inventive features include combined administration of naltrexone and bupropion within specified daily dose ranges or specific daily amounts, a comparative weight-loss outcome in major depressive disorder versus not, and formulation or administration refinements such as sustained release, a single oral dosage form, once per day administration, dosing order, and a weekly escalation and maintenance schedule.

The independent claims cover weight loss therapy in overweight or obese patients with major depressive disorder using combined naltrexone and bupropion, with either specified daily dose ranges or specific daily amounts. Both recite that the therapy provides about the same amount of weight loss compared with overweight or obese patients without major depressive disorder, and the claim set includes sustained release, single oral dosage form, once per day administration, relative dosing order, and a weekly escalation and maintenance schedule.

Stated Advantages

Documented Applications