ABC
1Main
2Brand NameRisperdal Consta
3Generic Namerisperidone
4Administrationq2w IM injection by physician. Must give with oral medication at initiation.
5EconomicsJ&J, 2.5% royalty and manufacturing revenue (7% mark up?).
6Approved10/29/2003 in the US.
7CompetitionInvega Sustenna (qm), Zyprexa Adhedra
8Sustenna approval path in Europe/Japan?
9HistoryPhase I started in 1996.
10IPMain Risperdal patent expired 6/29/08.
116110503 expires in 2017 and is an ALKS Medisorb patent.
127547452 2014
136667061 2020
146596316 2018
156403114 2017
166379703 2018
176368632 2014
186194006 2019
196110921 2014
205965168 2014
215916598 2017
225792477 2017
235688801 2014
24Cost$3k, $6k and $12k annually for low- mid- and high-dose. Sustenna more expensive.
25RXSustenna 410 scripts 11/6/09, 6% of combined drugs.
26PapersPaliperidone palmitate - review of the efficacy, safety and cost of a new second-generation depot antipsychotic medication. Citrome. IJCP 2009.
27Duration of Pharmacotherapy with Long-Acting Injectable Risperidone in the Treatment of Schizophrenia. Mohamed et al. Psychiatr Q 2009. - Demonstrates compliance may not be increased with Consta.
28Clinical Trials
29Phase III Consta vs Sustenna n=700 90-day
30
31Phase III Consta vs Sustenna n=452 in China 90-day
32
33Phase III Consta vs Sustenna n=748 360-day
34
35Phase II Consta vs Sustenna - to be reported at ACNP???
36150mg vs prior 50mg initiation dose