Biovail Corp. (BVF) said that Teva Pharmaceutical Industries Ltd.'s (TEVA) proposed Generic Wellbutrin XL trial will not likely effectively address the complaints of consumers because it is too small in size and too brief in duration.
Teva has proposed to conduct a trial in order to address reports of inefficacy and adverse events by consumers who switched from Biovail's FDA-approved brand of the antidepressant, Wellbutrin XL 300 mg, to Budeprion XL, Teva's generic formulation of the drug. The trial was described in a Dow Jones Newswire article dated December 2, 2009.
According to the December 2, 2009 article, the proposed study will enroll 138 patients who complained after switching from Wellbutrin XL 300 mg to Budeprion XL. Patients will be confined in a clinical setting for a total period of 24 days.
Biovail believes the size of the proposed Teva study, while much larger than needed for bioequivalence testing, is likely too small to demonstrate that Wellbutrin XL® 300 mg and Budeprion XL have similar safety, tolerability, and/or efficacy profiles.
Biovail also said that Budeprion XL is already deemed to be bioequivalent to Wellbutrin XL by the FDA as defined by existing standard FDA criteria. Biovail believes this determination is likely to be confirmed by the proposed new trial.
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