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.

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."