Alexza rockets on re-submission of Adasuve NDA
USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) saw its shares soar 44.9% to close at $3.97 on Friday, after the company said it has re-submitted its Adasuve (Staccato loxapine) inhalation powder New Drug Application to the US Food and Drug Administration in response to a complete response letter received last month, citing issues related to the company's manufacturing facility for the product. (The Pharma Letter May 7).
Loxapine already is approved in a capsule form for long-term treatment of schizophrenia. Adasuve is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. In the coming weeks, Alexza expects to hear from the FDA regarding the completeness of the re-submitted NDA, the classification of the re-submission (Class 1 or Class 2) and what the new Prescription Drug User Fee Act (PDUFA) goal date will be. Class 1 and Class 2 resubmissions have targeted review periods of 2 months and 6 months, respectively.
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