Forfivo XL Tablets Available for Major Depressive Disorder

Edgemont Pharmaceuticals announced that Forfivo XL (bupropion HCl extended-release tablets) is now available nationwide for the treatment of major depressive disorder (MDD). Forfivo XL, an aminoketone, is the only extended-release bupropion HCl 450mg product as a single tablet. Forfivo XL is bioequivalent to three tablets of Wellbutrin XL 150mg (GlaxoSmithKline).

The efficacy of Forfivo XL was established in two 4-week trials, one 6-week trial with bupropion immediate-release (IR) formulation, and one maintenance trial with bupropion sustained-release (SR) formulation. In the first study, patients were titrated in a bupropion HCl dose range of 300–600mg/day of the IR formulation on a three times daily schedule. This trial demonstrated the effectiveness of bupropion on the Hamilton Depression Rating Scale (HDRS) total score, the depressed mood (item 1) from that scale, and the Clinical Global Impressions (CGI) severity score. The second study included two fixed doses of the IR formulation of bupropion HCl (300 and 450mg/day) and placebo. This trial demonstrated the effectiveness of bupropion only at the 450mg/day dose of the IR formulation; the results were positive for the HDRS total score and the CGI severity score, but not for the HDRS item 1. In the third study, outpatients received 300mg/day of the IR formulation of bupropion HCl. This study demonstrated the effectiveness of bupropion on the HDRS total score, HDRS item 1, the Montgomery-Asberg Depression Rating Scale, the CGI severity score, and the CGI improvement score.

In a longer-term study, outpatients meeting DSM-IV criteria for MDD, recurrent type, were randomized to continuation of their same dose of bupropion or placebo, for up to 44 weeks of observation. Patients receiving continued bupropion treatment experienced significantly lower relapse rates over the subsequent 44 weeks compared to those receiving placebo.

Forfivo XL is available as 450mg dosage strength tablets in 30-count bottles.

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