A new major depressive disorder treatment of Vilazodone (Viibryd) just approved by FDA

Recently, the U.S. Food and Drug Administration (FDA) just approved Vilazodone hydrochloride tablets (marketed as Viibryd) from Clinical Data, Inc., for major depressive disorder treatment and medication.

Vilazodone is a combination of selective serotonin reuptake inhibitor (SSRI) and a partial agonist of serotonergic (5HT1A) receptors that firstable approved by FDA.

Although the mechanisms of this drug not fully understood, however, according to press release from Clinical Data, “it is thought to be related to its enhancement of serotonergic activity in the central nervous system through selective inhibition of serotonin reuptake.”

Carol R. Reed, MD, executive vice president and chief medical officer of Clinical Data said, “While there are currently available treatments for MDD, no on therapy works for every patients and side effect profiles vary, which may impact both compliance and treatment success.”

She add, “Viibryd will be a new choice for healthcare providers and their patients who are suffering from depression.”

The efficacy of this drug for MDD based on 2 randomized, double-blind trials in adults with MDD.

According to the results, Vilazodone 40 mg once daily was shown to be significantly superior to placebo at improving depressive symptoms. as measured by a mean change in the Montgomer-Asberg Depression Rating Scale total score from baseline to week 8.
Patients in the study were titrated up to the 40-mg dose over the course of 2 weeks.

Due to safety studies, most common adverse events were diarrhea, nausea, vomiting, and insomnia.
The study itself involved 2177 patients diagnosed with MDD.

The company said that 7.1% of total patients who received vilazodone discontinued treatment because of an adverse reaction compared with 3.2% of control patients.
Also, the company added that the drug was not associated with change in body weight over 8 weeks, and there were no reported drug-related abnormalities in hepatic or cardiac parameters or vital signs.

In addition, the company added other side effects of sexual dysfunction. According to the company, the comparison between vilazodone and control patients as following;
- decreased libido (4% in vilazodone, and 1% in control patients),
- abnormal orgasm (3% in vilazodone, and 0% in control patients),
- delayed ejaculation (2% in viladozone, and 0% in control patients), and
- erectile dysfunction (2% in viladozone, and 1% in control patients).

Finally, the company said that the drug will be dispensed in tablets of 10 mg, 20 mg, and 40 mg, with planned availability in the second quarter of 2011. As with other antidepressant, the labeling will carry a boxed warning about increased risk for suicidality and suicidal behavior in children, adolescents, and young adults.