Shire to End Major Depression Drug Booster Development

(National Institute of Drug Abuse)

7 February 2014. Shire PLC, a pharmaceutical company in the U.K., will end trials of its drug Vyvanse as a supplement to anti-depressants for treating major depressive disorder. The company made the decision following results of two late-stage clinical trials that show the drug failed to meet the studies’ effectiveness objectives.

Vyvanse (lisdexamfetamine dimesylate) is given in capsule form, and remains inactive until metabolized in the body to release active molecules for d-amphetamine, a common prescribed compound for attention deficit hyperactivity disorder for ADHD. FDA approved Vyvanse as a treatment for ADHD in the U.S. in 2008, and is approved as well in Canada and Brazil.

Shire was testing Vyvanse as a supplement for anti-depressant drugs to treat major depressive disorder. This type of depression is marked by extended and severe symptoms, such as feelings of sadness and hopelessness, loss of interest in work or hobbies, fatigue, insomnia, and thoughts of suicide. Major depression can result initially from minor or short-term depressive episodes, under two weeks in length, but become more frequent, longer, and disabling.

According to Shire, the two clinical trials enrolled 404 and 426 adults respectively diagnosed with major depressive disorder. In the studies, patients were given one of two types of widely-prescribed antidepressants: selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors. Participants were then randomly given either Vyvanse or a placebo.

Both trials measured the effects of the combined drugs with the Montgomery-Asberg Depression Rating Scale, a standard behavioral gauge of depression. In both trials, patients taking the anti-depressants plus Vyvanse showed a 6 to 7 point drop in depression behavior scores, but those reductions were almost identical to patients taking anti-depressants plus a placebo. The safety results were also similar between the test and placebo groups, with the percentage of patients reporting adverse effects similar to those taking Vyvanse for ADHD, its approved use.

Shire says it plans to ask FDA to approve Vyvanse as a treatment for binge eating disorder, a condition officially recognized in psychiatry’s diagnostic manual, the Diagnostic and Statistical Manual of Mental Disorders. In May 2013, the company reported results of a clinical trial showing Vyvanse almost completely stopping eating binges among adults, some of whom experienced as many as four of binge episodes a week.

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Hat tip: FirstWord Pharma

Updated: 25 Oct. 2022

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