An academic debate: OnabotulinumtoxinA for chronic migraine: PREEMPT-derived vs "customized" dosing/injection paradigm.

In 2010 onabotulinumtoxinA (OnabotA) was approved by the United States Food and Drug Administration for the treatment of chronic migraine (CM). Data supporting approval were derived primarily from two parallel placebo-controlled trials, the PREEMPT studies. Many clinicians and research investigators critical of those data have recommended that the dosing/injection paradigm for treating CM be "customized" to the needs of the individual patient rather than administered in a uniform fashion conforming to the methodology utilized in the PREEMPT studies. In this paper the authors debate the issue of whether treatment of CM with OnabotA should be standardized versus customized.