Posted by Novelagent on September 13, 2012, at 15:46:32
In reply to Lundbeck: FDA accepts review of schizophrenia drug, posted by herpills on September 13, 2012, at 14:11:34
Unfortunately, unless they've made some changes, it requires injection into the buttocks. Not worth it for a marginal benefit over Invega Sustenna once-monthly, especially since Sustenna is starting phase III trials for a 3-month injection formulation, expected in 2014.
My nurse said Risperdal Consta intially was injected into the buttock. Over time that changed to the arm.
I don't understand why the FDA takes so long for an injection formulation to get passed-- especially since it's schizophrenia, so it's likely designated with fast-track designation.
All that means is they hold FDA meetings more frequently, but there's still considerable time that elapses between regulatory meetings, and the drug maker can't advance with their trials until they have those meetings.
Latuda's maker vaguely says they're working on a long-acting injection, but they're not even specifying what stage they're in, so that means they likely haven't even started yet, and it takes 2 years after they start phase III trials, so that means it's going to be forever because they haven't even done phase II yet.
Shire's Vyvanse is heading to phase III for negative symptom predominant schizophrenia, and they have fast-track designation for that, but even so, they might not begin phase III until early next year. I just hope the subjects in that study bother to comply with their antipsychotic, and not ruin it for everyone else.
> (Reuters) - Danish pharmaceutical group Lundbeck said the U.S. Food and Drug Administration was to review a resubmission of a new drug application for treating schizophrenia.
>
> A new FDA deadline to make a decision regarding the treatment, aripiprazole depot formulation, had been set for Feb. 28, Lundbeck said on Wednesday in a statement with Japanese firm Otsuka Pharmaceutical Co with whom it is in partnership, following initial deficiencies in the application.
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> Lundbeck has co-development and co-commercialisation rights to aripiprazole depot formulation in North and Latin America as well as Europe, Australia and some other countries.
>
> (Reporting by Copenhagen Newsroom; Editing by Dan Lalor and Gerald E. McCormick)
poster:Novelagent
thread:1025561
URL: http://www.dr-bob.org/babble/20120912/msgs/1025570.html