(dailyRx News) Sanofi-aventis U.S. has announced that Aplenzin (bupropion hydrobromide) extended-release tablets, an effective bupropion therapy for the treatment of major depressive disorder (MDD), is now available by prescription for adults ages 18 and older.
Aplenzin differs from other generic and branded bupropion antidepressants because it provides a unique hydrobromide (HBr) salt extended-release formulation, offering patients the benefit of convenience with simple one-tablet, once-daily dosing at all doses.
"For patients who show little clinical improvement on lower doses of bupropion, there is a need to take higher doses to treat major depressive disorder," said Prakash Masand, M.D., consulting professor of psychiatry and behavioral sciences at Duke University Medical Center in Durham, North Carolina. "Aplenzin offers patients and physicians an alternative option which only requires one tablet, once a day at the highest bupropion dose."
For those patients in whom no clinical improvement is noted after several weeks of treatment at the target dose of 348 mg per day, Aplenzin offers physicians the ability to gradually increase the dose to the 522 mg strength. The Aplenzin 522 mg dose is the only FDA-approved single-tablet, once-daily treatment equivalent to 450 mg of bupropion HCl therapy, which requires two or three tablets daily.
Bupropion, the active ingredient in Aplenzin, offers comparable efficacy to fluoxetine (Prozac), a selective serotonin reuptake inhibitor. Bupropion also has low incidence of weight gain compared to placebo. The mechanism of action of Aplenzin is unknown; however, it is believed that bupropion may help restore the balance of neurotransmitters in the brain that causes MDD by inhibiting the reuptake of norepinephrine and dopamine.
Aplenzin was approved by the FDA in April 2008.