Shares of Alexza Pharmaceuticals, Inc. (ALXA) are surging over 20 percent in pre-market activity after the firm said Friday that it has resubmitted its Adasuve New Drug Application to the U.S. Food and Drug Administration, following a Complete Response Letter received in May.
Adasuve is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
It was in early May that Alexza revealed a CRL regarding its NDA for Adasuve (loxapine) inhalation powder, 5 mg and 10 mg, citing manufacturing deficiencies at its Mountain View, California facility.
The FDA said in the letter, "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 said at that time that it believes the deficiencies in the CRL concern medical devices and can be addressed readily. The company has now made submissions directly to Center for Devices and Radiological Health Office of Compliance and the San Francisco District Office, to fully address the deficiencies.
The company said then 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. In the NDA resubmission, Alexza has submitted updated draft labeling.
Alexza said today that it expects to hear from the FDA shortly regarding the completeness of the resubmitted NDA, the classification of the resubmission and what the new Prescription Drug User Fee Act goal date will be.
The company had received a CRL from the FDA previously in October 2010, citing breathing-related concerns associated with Adasuve.
ALXA, which closed at $2.74 on Thursday, is climbing 20.4 percent in pre-market trading.
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