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Executive Summary

Burroughs Wellcome's Wellbutrin (buproprion) for second line treatment of depression will be launched in "early spring," according to the company. FDA approved the drug Dec. 30, four years after Burroughs Wellcome filed an NDA in December 1981 and one year after FDA determined the drug was approvable. Approved labeling states: "Wellbutrin is indicated for the treatment of depression in patients who fail to respond adequately to, or who cannot tolerate, alternative antidepressant treatments. Wellbutrin is not recommended as an antidepressant of first choice for most patients because its use at doses approximately one-and-one-third times greater than the usual required daily dose (450 mg) is associated with a high risk of seizure." The agency classified Wellbutrin as a 1B drug, signifying a new chemical entity with modest therapeutic gain over other marketed drugs. The drug gives Burroughs-Wellcome an entry into the antidepressant market. Labeling includes a bold faced warning against use in patients with seizures. The physician insert also notes that Wellbutrin should not be used with monoamine oxidase inhibitors or in patients who have shown an allergic reaction to the drug. With regard to length of therapy, the labeling states: "While it is generally recommended that a course of antidepressant drug treatment should continue for several months and many patients have been treated with Wellbutrin in long-term clinical trials of up to two years duration, there has been no systematic placebo controlled evaluation of the efficacy of Wellbutrin for a period beyond three to four weeks." FDA's Psychopharmacologic Drugs Advisory Cmte. recommended approval of Wellbutrin in June 1982. At that time, cmte. reviewer Donald Robinson, MD, Marshall University, said the data supported short-term efficacy but effectiveness was not shown for long-term use.

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