|
Main | | |
| Brand Name | Risperdal Consta |
| Generic Name | risperidone |
| Administration | q2w IM injection by physician. Must give with oral medication at initiation. |
| Economics | J&J, 2.5% royalty and manufacturing revenue (7% mark up?). |
| Approved | 10/29/2003 in the US. |
| Competition | Invega Sustenna (qm), Zyprexa Adhedra |
| | Sustenna approval path in Europe/Japan? |
| History | Phase I started in 1996. |
| IP | Main Risperdal patent expired 6/29/08. |
| | 6110503 expires in 2017 and is an ALKS Medisorb patent. |
| | 7547452 2014 |
| | 6667061 2020 |
| | 6596316 2018 |
| | 6403114 2017 |
| | 6379703 2018 |
| | 6368632 2014 |
| | 6194006 2019 |
| | 6110921 2014 |
| | 5965168 2014 |
| | 5916598 2017 |
| | 5792477 2017 |
| | 5688801 2014 |
| Cost | $3k, $6k and $12k annually for low- mid- and high-dose. Sustenna more expensive. |
| RX | Sustenna 410 scripts 11/6/09, 6% of combined drugs. |
| Papers | Paliperidone palmitate - review of the efficacy, safety and cost of a new second-generation depot antipsychotic medication. Citrome. IJCP 2009. |
| | Duration 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. |
| Clinical Trials | |
| | Phase III Consta vs Sustenna n=700 90-day |
| | |
| | Phase III Consta vs Sustenna n=452 in China 90-day |
| | |
| | Phase III Consta vs Sustenna n=748 360-day |
| | |
| | Phase II Consta vs Sustenna - to be reported at ACNP??? |
| | 150mg vs prior 50mg initiation dose |