FDA accepts new schizophrenia drug filing
pharmafile | September 24, 2014 | News story | Sales and Marketing | FDA, Lundbeck, Otsuka, brexpiprazole, depression, schizophrenia
The FDA is reviewing Otsuka and Lundbeck’s brexpiprazole for the treatment of schizophrenia and as an adjunctive therapy for the treatment of major depression (MDD).
The New Drug Application (NDA) is supported by seven placebo-controlled Phase II and III trials for the drug, covering over 6,000 participants, more than 5,000 of whom received the treatment.
In the two Phase III schizophrenia trials, patients receiving brexpiprazole showed greater improvement in symptoms compared to the placebo group, measured by a change from baseline in the Positive and Negative Syndrome Scale (PANSS).
Results of the key secondary endpoint supported primary results in one of the trials. A clinically meaningful improvement was observed in the Phase II schizophrenia trial, but it was not statistically separate from the placebo results.
In the other four trials, brexpiprazole was tested in patients suffering from MDD who had previously demonstrated an inadequate response to other antidepressants. Patients taking brexpiprazole with antidepressants showed more improvement when compared to patients taking antidepressants with a placebo.
Brexpiprazole was discovered by Otsuka and is considered to be a successor to its top-selling antipsychotic – and NICE-approved – drug Abilify (aripiprazole). It is a serotonin-dopamine activity modulator (SDAM), and is believed to possess a balanced combination of binding affinity and functional activities at multiple receptors in the brain.
William Carson, president and chief executive of Otsuka pharmaceutical development and Commercialisation, says: “We and our collaborator Lundbeck are proud to have reached this juncture in the development of brexpiprazole.
“In view of the importance of good mental health and the projected impacts of mental health disorders on people affected, their families and society, future new treatment options will be indispensable.”
With an estimated 2.4 million Americans suffering from schizophrenia and one in 100 developing the condition worldwide, brexpiprazole could have a large impact on the market if it is approved. It may face competition from Alkermes’ aripiprazole lauroxil, however, which has also recently sought regulatory approval from in the US.
The FDA is expected to complete its review of brexpiprazole by July next year.
George Underwood
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