FDA issues Complete Response Letter to Alexza Pharma for Adasuve - 04-May-2012

Alexza Pharmaceuticals announced that it has received a Complete Response Letter(CRL) from the FDA regarding its New Drug Application (NDA) for ADASUVE (loxapine) inhalation powder, 5 mg and 10 mg. The CRL was issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form. Adasuve is being developed for the acute treatment of agitation associated with Schizophrenia or Bipolar I Disorder in adults. In the CRL, the FDA noted, "During a recent inspection of the Mountain View, CA manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility. Satisfactory resolution of these deficiencies is required before this application may be approved." Alexza believes the deficiencies are medical device specific and readily addressable.