Skip to Main Content

The regulatory plans for Alkermes and its controversial drug for treatment-resistant depression have been upended by the Food and Drug Administration.

On Monday, the FDA said it would not review the Alkermes drug, called ALKS-5461, because of “insufficient evidence of overall effectiveness,” the company said in a statement. The FDA told Alkermes that additional “well-controlled clinical trials” would need to be conducted for the drug to be resubmitted.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

GET STARTED
  • Not just this drug – selective reporting and all types of biases appear to operate for ALL psychiatric drugs. Some of these issues are exposed in the following articles:

    Lancee, M., et al. (2017), Outcome reporting bias in randomized-controlled trials investigating antipsychotic drugs, Translational Psychiatry, 7, e1232.

    Hengartner MP (2017) Methodological Flaws, Conflicts of Interest, and Scientific Fallacies: Implications for the Evaluation of Antidepressants’ Efficacy and Harm. Front. Psychiatry8:275.

    Also, the site madinamerica.com promotes critical dialogue regarding these issues.

  • Correction: ITCI submission is based on two successful trials and one failed — not 1 successful and 1 failed

  • Maybe the gold standard is coming back, Alks. Treatment resistant depression is a non sequiter anyway. In the old days when actual psychiatrists treated depression they were usually able to find a combo that worked. Now that insurance cos have stiffed the shrinks, depression gets treated by primary care docs who don’t know jack s*it about depression, and when SSRI fails, they throw up their hands and declare the depression resistant. The best treatment for resistant depression is 20 to 30 zaps with the ECT machine.

Comments are closed.