Alexza announced today (Oct 11, 2010) that they have received a Complete Response letter from the FDA. That they did not get an approval is not a surprise (see our earlier opinion). It’s also not a surprise to us that one of the concerns that the FDA has regards the delivery device, a new device that has yet to be approved for use with any drug. What is a surprise is the safety issue raised by the FDA regarding pulmonary function tests from 3 Phase I safety studies. Yes, Phase 1 studies. Why wasn’t this addressed at the End of Phase 2 meeting?
Posts tagged ‘Alexza Pharmaceuticals’
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.