Wednesday, October 26, 2011

FDA Slams Viibryd: Better Sexual Profile Claim “Not Supported by the Data”

The September 2011 issue of the Journal of Clinical Psychiatry created history in two ways.

First, the journal published this article written by FDA staff critically reviewing the efficacy and safety data of Viibryd, a new antidepressant that the same FDA staff had just approved.

Second, it was not just any journal that published the article, but the Journal of Clinical Psychiatry. Why is this so historic? Anybody who has followed this blog over the years has noticed a certain…shall we say, skepticism...toward many of the articles published in JCP, especially those published in its industry-funded supplements. But in this case I'm happy to give the journal kudos for having the courage to publish an article critical of an antidepressant made by a company that pays for drug ads.

Not that any of this information is truly new. Back in April of 2011, my own Carlat Psychiatry Report actually scooped JCP on this issue, when Jim Phelps and I reported in this article that Viibryd-funded authors had tweaked sexual side effect data to make the drug appear “cleaner” than its SSRI competitors.  (Some of this tweaking, interestingly enough, occurred in the pages of the Journal of Clinical Psychiatry).

In fact, as we reported and as this new paper elaborates, the studies proved nothing at all about Viibryd’s side effects, because they artfully omitted a crucial element—the inclusion of a comparator SSRI known to cause sexual dysfunction.

The other claim put to bed by the FDA is the idea that Viibryd is quicker to work than other antidepressants. This was based on one of Forest’s trials which showed that Viibryd separated from placebo by week one. The FDA’s article pointed out two problems. First, this data was from Trial 04, which was only one of two large trials submitted as part of the new drug application. In the other trial, Trial 07, Viibryd did not separate from placebo until week 4. Second, neither trial compared Viibryd with an already approved SSRI, meaning that no statements can be made about the new drug working faster than any other drug.

It’s nice to see the FDA stepping up to the plate and proactively publishing articles that dispel company-spread rumors about drug effectiveness. And it’s also great that a usually industry-friendly journal like JCP would publish this.


beenthere/donethat said...

Interesting disconnect on the Forest Labs page for Viibryd: "Call your healthcare provider right away if you have any of the following symptoms ... coma or other changes in mental status..." This does not instill a lot of confidence - or this drug has some truly outstanding positive side effects.

Dr John said...

Wow.. the introduction of yet another turd into the bowl of antidepressant medications.Ground breaking work continues to take place is psycho-pharmacolgy...ZZZZ

Sean Paul said...

I am a resident and am conflicted about starting the newer medications. I feel like any time that these medications are touted as "having a neutral metabolic profile" or "less sexual side effects" they turn out to be debunked when looked at in large population trials. Good for the FDA for pointing this out.