Adasuve Staccato loxapine regulatory update

FDA issued a complete response letter for an NDA from Alexza for inhaled Adasuve Staccato loxapine to treat agitation in patients with schizophrenia or bipolar disorder. According to Alexza, FDA said it identified manufacturing deficiencies at the company's Mountain View, Calif., plant during a recent inspection. Alexza said it believes the deficiencies are "medical device specific and readily addressable." The agency did not identify any clinical or safety issues.

In January, FDA extended the PDUFA date for Adasuve by 3 months. At the time, FDA said it needed more time to review an updated REMS proposal submitted by the company on Jan. 10 to address topics discussed last December at an agency advisory committee meeting. Based on the complete response letter, Alexza believes there is "substantial agreement" with FDA on the REMS. The advisory committee voted 9-8, with 1 abstention, in favor of recommending approval of Adasuve (see BioCentury, Jan. 30). ...