Archive for September, 2010

Clinical Data’s vilazodone – is this novel antipressant any better than alternatives?

Posted by lifetech on September 16th, 2010

The US antidepressant market is estimated at $12 billion per year, and includes some of the best selling drugs on the market today – the serotonin reuptake inhibitors (SSRIs and SNRIs). But despite their commercial success, the unmet medical need remains given that only about half of patients respond to each drug. In addition, antidepressants suffer from slow onset of action and numerous side effects that undermine patient compliance and, ultimately, response to therapy.

¬†Clinical Data’s vilazodone is a dual acting antidepressant, with bona fide SSRI activity plus partial agonism of the 1A serotonin receptor that is hypothesized to be involved in SSRI onset of action and side effects. The drug failed to impress in phase II, but by increasing the dose and modifying other study parameters in phase III, vilazodone hit all five efficacy endpoints. Vilazodone appears to be at least as safe as other approved antidepressants, with a lower rate of sexual side effects. Vilazodone is now under FDA review, with a decision expected by January 2011. Yet the greatest challenge facing CLDA may come not from regulators but from competing antidepressants, which have become commercial juggernauts despite their pharmacological flaws. Can vilazodone succeed in the minds of regulators, physicians and (most importantly) patients? Take a look at our latest report for our thoughts on these issues.