ACEMAP (penfluridol) - Schizophrenia

The clinical benefit of ACEMAP (penfluridol) 20 mg tablets is substantial in the MA indication.

Considering:

• data from the literature (Cochrane review, Soares B.G.O, 2012) having suggested:
  • the superiority of penfluridol compared to placebo for improvement in CGI score (RR=0.69; 95% CI [0.56; 0.85]) and the lower need for additional antipsychotic medication (RR=0.43; 95% CI [0.24; 0.77]),
  • the absence of a difference between penfluridol and first-generation long-acting oral or injectable antipsychotic drugs for these same outcome measures,
• the limitations associated with this Cochrane review (small numbers of patients included in the studies, allocation regimen not specified, population included different from the target population, comparator not available in France, subjective assessment of efficacy endpoints, transposability, age of the studies included),
• the absence of comparative efficacy data versus the second-generation long-acting antipsychotic drugs available,
• the absence of evidence concerning quality of life,
• the oral administration of the medicinal product compared to the other long-acting antipsychotics available in injection form only, enabling a new method of administration, with no formal evidence of an improvement in care conditions,
• the similar safety profile to that of other first-generation antipsychotic drugs,

the Committee deems that ACEMAP (penfluridol) 20 mg tablets provides no clinical added value (CAV V) in the current care pathway for the maintenance treatment of schizophrenia in adults.