The FDA has issued a complete response letter to Alexza Pharmaceuticals regarding its New Drug Application (NDA) for Adasuve loxapine inhalation powder for the treatment of agitation associated with schizophrenia or bipolar I disorder in adults. The FDA had previously extended the review period after Alexza submitted an updated proposed Risk Evaluation and Mitigation Strategy (REMS) program in January 2012.
According to Alexza, the CRL said, “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 says that it “believes the deficiencies are medical device specific and readily addressable” and that it will schedule a meeting with the FDA as soon as possible to get more information about the deficiencies. The company also points out that the CRL cited no clinical or safety issues but did identify issues with the draft product labeling.
Read the Alexza press release.
