Mental Health Blogs

I bring this up because it’s been four months since an FDA advisory panel very reluctantly recommended that the FDA proper approve AstraZeneca’s atypical antipsychotic Seroquel (in XR form) as an add-on, or adjunctive treatment, for depression. The same panel recommended against FDA approval of the drug for anxiety as well as a maintenance therapy for depression (meaning long-term use) and as a monotherapy for depression (meaning a replacement for SSRIs and SNRIs). The panel found that the drug didn’t meet safety and efficacy standards to merit its approval as anything except an add-on therapy.

While there’s no set schedule for when the agency must accept or reject an advisory panel’s findings, the agency generally doesn’t wait for four months to make a determination. So something fairly unusual is going on here.

My own guess is that one of two things is happening to account for the slowdown:

1. AZ is lobbying the FDA like crazy to convince them that the panel had it wrong and that Seroquel is awesome for anxiety and depression, not just as an add-on for depression. Technically, the FDA is not bound by a panel’s recommendation and can go in whatever direction it likes with approval or non-approval.

2. The FDA is wrestling with the panel’s approval recommendation for add-on status in light of the drug’s very small advantage over placebo–just 5 percent, according to Tufts University psychiatrist Danny Carlat. Technically, the FDA has to approve any drug that can demonstrate any level of efficacy over placebo, regardless of how small the advantage, so my hunch is that the slowdown could well have to do with safety questions around the drug.

There are other possibilities, of course, but it does strike me as unusual that this is going on and I thought I’d note it for you all. I bet the drug’s limbo status is driving AZ bonkers.

Personally, I hope the FDA finds the drug non-approvable for any new indication due to its teensy efficacy and rotten side effect profile.

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Related posts:

1. Seroquel Gets FDA Approval For Use In 10-Year-Olds
2. Travel Day, Comment Approval May Be Intermittent
3. FDA Approves Seroquel As Add-On Treatment For Depression
4. Shire Trialing ADHD Drug As Add-On Depression Treatment
5. Study Uses Deception To Claim Antipsychotics Are Awesome Depression Treatments