Allergan and Gedeon Richter’s long road to market for schizophrenia candidate cariprazine just got a little longer, as the FDA has taken another three months to review the drug.
Cariprazine has already been turned down once by the US regulator, which asked for additional clinical data on the drug’s use in schizophrenia and mania in bipolar disorder towards the end of 2013, despite concluding that cariprazine showed efficacy in the two indications.
Now, the FDA says that information submitted by Allergan and Gedeon Richter constitutes a “major amendment” to the dossier so it will need more time to complete its review. The new deadline extends the FDA’s review deadline from this month to September.
New phase III clinical data reported in January showed cariprazine cut the risk of relapse in patients with schizophrenia by 55% versus placebo. Gedeon Richter also presented results recently of a study that seemed to show the drug has activity against the negative symptoms of schizophrenia such as apathy and withdrawal, which are poorly addressed by current treatments.
The drug is one of several new antipsychotic agents expected to drive growth in the schizophrenia market in the coming years, along with Johnson & Johnson’s three-monthly paliperidone palmitate depot, Alkermes’ once-monthly depot formulation of aripiprazole lauroxil and Otsuka and Lundbeck’s brexpiprazole, according to Decision Resources.
Analysts at Canaccord Genuity said last month that they expect cariprazine to have $500m annual peak sales potential.
Cariprazine was originally developed by Gedeon Richter and is an antagonist of the dopamine D3, D2 and serotonin 2B receptors, which play a part in the development of psychiatric conditions.
North American rights to the drug were bought by Forest Labs, acquired last year by Actavis, which in turn merged with Allergan and officially adopted the latter company’s name.
Cariprazine is also being tested in clinical trials as an adjunct therapy to major depressive disorder and for bipolar depression.