The FDA's Psychopharmacological Advisory Committee voted last week to recommend that Seroquel be approved as an adjunctive treatment for depression, but it rejected AstraZeneca's request that the drug be approved as monotherapy treatment for depression or generalized anxiety disorder.
According to this article in The Philadelphia Inquirer, "Panel members, including scientists from outside the FDA and consumer advocates, said Seroquel's risks in depression and anxiety outweighed its benefits."
One of the panel members, Richard Malone, explained that "the risks are fairly well-documented, and I don't think they are acceptable for this use."
While I agree with the committee's rejection of two indications, I'm concerned that they were inappropriately impressed by the Seroquel augmentation data. As far as I know, the augmentation studies have not been published, but a summary can be found on page 27 of AZ's briefing document. It looks like they used the same research design as BMS did in their Abilify augmentation studies, and that the Seroquel results were equally unimpressive (see this article at Clin Psych for a slam of the Abilify data). Seroquel reduced the MADRS depression score by about 15 points, while placebo decreased it by about 12 points. This 3 point advantage is tiny, considering that the MADRS is a 60 point scale. Personally, I don't think that this 5% advantage (3 divided by 60 possible points) is worth Seroquel's side effects.
Particularly since this recently published randomized trial showed that when Seroquel was added to Prozac, it yielded no advantages over placebo, aside from helping patients sleep better over the first few weeks. This was not a study of treatment-resistant patients (unlike the FDA data) but it nonetheless shakes my confidence in the potency of the medication.
If the full FDA decides to go along with the committee's recommendation, AZ will mount the kind of mega direct-to-consumer marketing campaign that we have seen with Abilify (for background, see two excellent LA Times pieces here and here), and consequently there will be a little epidemic of obesity among depressed patients. Now that's what I call depressing!