Of Persistence and Ethics in Phase III

Persistence paid off for Lundbeck and Takeda, whose first Phase III program for their antidepressant Lu AA21004 failed. With revised dosing, they ran another extensive set of pivotal trials, have announced that they will be filing for regulatory approval in both the US and EU during 2H:12. The rumor is that they may have achieved a better efficacy/AE side effect profile than seen with SSRIs, but we await the details. Along with the positive depression results announced recently by Forest/Pierre Fabré (levomilnacipran) and Sunovion (lurasidone), this shows that the pessimism that had gripped the depression area after the failure of the Targacept/Astra Zeneca pivotal program was overblown–it is still possible to run a successful Phase III program in depression.

Lundbeck and Otsuka’s Phase III testing of aripiprazole one-month IM depot in schizophrenia was also successful: It reduced the likelihood of ‘imminent relapse’ (where an increase in PANSS score led to the offer of ‘rescue’ antipsychotics) to 10%, compared to almost 40% in the placebo group. But it is striking, given that the whole point is to assess whether the IM depot is a valid replacement for daily oral administration, that  the FDA and EMA required that the sponsors stabilize schizophrenics for 20-30 weeks, then take them off their antipsychotic meds for a year to assess the relapse rate for a reformulated drug. There is something ethically and morally dubious about requiring that chronic patients be placed back on the slippery slope to psychotic decompensation. It would seem that a trial assessing non-inferiority  compared to oral aripiprazole would be more relevant, and safer. The self-serving claims by regulatory bureaucracies that they are all about patient safety lose some credibility with these kinds of requirements.•

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1 Response to Of Persistence and Ethics in Phase III

  1. Pingback: Application for Service Corps programme (Phase III) to close next Monday - GROWGENIC

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