Alexza Pharmaceuticals Inc. (ALXA) announced that it has received a Complete Response Letter or CRL from the U.S. Food and Drug Administration or FDA regarding its New Drug Application or NDA for Adasuve (loxapine) inhalation powder, 5 mg and 10 mg. Adasuve is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
The FDA's Center for Drug Evaluation and Research issued the CRL indicating that the NDA review cycle is complete and the application is not ready for approval in its present form.
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. Alexza said it plans to meet with the FDA to gain a better understanding of the specific deficiencies and this meeting will be scheduled as soon as practical.
Alexza said that there were no new clinical or safety issues identified and there were no other deficiencies outlined in the CRL. The CRL also contained comments on Alexza's draft product labeling.
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