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New Drug Pregabalin Effective for Generalized Anxiety: Presented at APA

By Alison Palkhivala

PHILADELPHIA, PA -- May 23, 2002 -- A new drug for the treatment of generalized anxiety disorder may be on the way. The drug, called pregabalin, appears to be at least as good as benzodiazepine and selective serotonin reuptake inhibitor therapy for the treatment of generalized anxiety disorder, according to two short-term studies.

These findings were presented here this week at the annual meeting of the American Psychiatric Association (APA).

In one study, 455 patients with moderate to severe generalized anxiety disorder (GAD) were randomized to pregabalin (300 mg/day, 450 mg/day, or 600 mg/day), the benzodiazepine alprazolam (1.5 mg/day), or placebo for four weeks in a double-blind fashion.

At the end of the study, patients on both pregabalin and alprazolam were significantly improved with respect to their anxiety symptoms compared to placebo, as measured by the Hamilton Rating Scale for Anxiety (HAM-A). The patients on pregabalin also had more improvement sooner than those on alprazolam, and improvement in both the pregabalin and alprazolam groups was sustained for the duration of the study.

In another double-blind study, 426 patients with moderate to severe GAD were treated with pregabalin (400 mg/day or 600 mg/day), the selective serotonin reuptake inhibitor (SSRI) venlafaxine, or placebo. Both the pregabalin and venlafaxine groups had significant improvements in anxiety compared to placebo at the end of six weeks. Rates of improvement at week 1 were higher among the pregabalin group than in either the venlafaxine or placebo groups.

In both studies, dizziness and drowsiness were the most common side effects seen with pregabalin, and these were generally mild to moderate. The research was led by Karl Rickels, MD, professor of psychiatry at the University of Pennsylvania, Philadelphia, Pennsylvania.

Pfizer Inc., manufacturer of pregabalin, plans to submit a New Drug Application (NDA) for pregabalin to the US Food and Drug Administration (FDA) by the end of 2002.

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