Perampanel (1) – Fycompa®

• Clinical trials
  • All randomised controlled trials (RCTs) identified for perampanel are placebo-controlled and, on their own, are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy.

Patients receiving lamotrigine as monotherapy

• In cases where lamotrigine is used as monotherapy, topiramate as add-on therapy constitutes the appropriate comparator therapy.
• As neither the direct comparison nor the indirect comparison can therefore provide valid results for the benefit assessment of perampanel, the additional benefit of perampanel is not proven.
• For the results of the indirect comparison with perampanel, the pharmaceutical manufacturer, as was the case for the direct comparison, includes only that patient population from the three registration trials who received lamotrigine plus at least one other antiepileptic drug as baseline therapy.
• On the Lamotrigine side, the pharmaceutical manufacturer includes two placebo-controlled studies¹⁻². In these studies, it can be ruled out that lamotrigine was used as part of the baseline therapy, as lamotrigine is, on the one hand, the treatment under investigation and, on the other hand, did not receive marketing authorisation at the time the studies were conducted.
• Consequently, given that all patients in the perampanel arms of the perampanel studies had also received lamotrigine, this indirect comparison does not constitute a comparison of perampanel as add-on therapy with lamotrigine as add-on therapy. Rather, the comparison here is between the combination of perampanel and lamotrigine and lamotrigine alone, in each case as an adjunct to a standard treatment regimen of anti-epileptic drugs.

Courtesy translation only, please refer to the German original.