Alexza Pharmaceuticals announced that it has resubmitted its New Drug Application (NDA) for Adasuve (Staccato loxapine) inhalation powder, an agent being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults, in response to a complete response letter (CRL) received in May 2012.
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 has stated that it believed the deficiencies were medical device specific and readily addressable.
The May 2012 CRL also contained comments on Alexza’s draft product labeling. In the NDA resubmission, Alexza has submitted updated draft labeling which is intended to be responsive to the comments provided by FDA.
There were no new clinical or safety issues identified and there were no other deficiencies outlined in the CRL. With respect to the Adasuve Risk Evaluation and Mitigation Strategy (REMS), the CRL stated that discussions can continue on the proposed REMS after the response to the CRL has been submitted.
Adasuve is an anti-agitation product that combines loxapine, an antipsychotic, with Alexza’s Staccato system that vaporizes the drug into small particle aerosol for inhalation, which allows for rapid onset of action.
For more information call (650) 944-7000 or visit www.alexza.com.