October 11, 2010 is the PDUFA Date for Alexza Pharmaceuticals STACCATO loxapine, an inhalation formulation of loxapine intended for rapid treatment of schizophrenia and bipolar disorders. The company reports that this is the first NDA that it has submitted using the STACCATO inhalation technology. Phase III clinical studies are reported as having been submitted that support both indications but few details are available other than reports that both primary and secondary endpoints were met. Getting approval for both indications using new technology seems like a bit of a hurdle for a company that is submitting its first NDA.
Posts tagged ‘bipolar’