>>MOUNTAIN VIEW, Calif., Oct. 11 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA - News) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato® loxapine), submitted as Adusuve™ Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg. A CRL is issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form. AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.
In the CRL, the FDA stated that their primary clinical safety concern was related to data from the three Phase 1 pulmonary safety studies with AZ-004. This concern was primarily based on observed, dose-related post-dose decreases in forced expiratory volume in one second, or FEV1, a standard measure of lung function, in healthy subjects and in subjects with COPD and asthma. The agency also noted that decreases in FEV1 were recorded in subjects who were administered device-only, placebo versions of AZ-004. Alexza intends to meet with the FDA in the near future to discuss steps to address this FDA concern. As Alexza has previously reported, there were no serious or severe respiratory adverse events in these trials or reported in the two Phase 3 clinical trials of AZ-004. All respiratory symptoms that developed after treatment in the Phase 1 subjects with COPD and asthma were either self-limiting or readily managed with an inhaled bronchodilator.
The CRL also raised issues relating to the suitability of the stability studies undertaken by Alexza and certain other items relating to the agency's recently completed pre-approval manufacturing inspection. Because AZ-004 incorporates a novel delivery system, the CRL also included input from FDA's Center for Devices and Radiological Health (CDRH). CDRH requested a human factors study and related analysis to validate that the product can be used effectively in the proposed clinical setting. CDRH also requested further bench testing of the product under an additional "worst-case" manufacturing scenario.
"We are reviewing the Complete Response Letter and plan to meet with the FDA as soon as possible to discuss the Agency's pulmonary safety concern. Alexza shares the agency's deep interest in patient safety, and believes the pulmonary data is supportive of the safety of AZ-004. We look forward to discussing the appropriate way to address this issue," said Thomas B. King, Alexza President and CEO. "We are also undertaking steps to address the other items raised in the CRL. We appreciate the FDA's review of the first NDA for our novel Staccato technology, and we expect to work closely with FDA to resolve the issues raised in the Complete Response Letter. Alexza continues to believe in the safety and efficacy of AZ-004 based on the comprehensive clinical development program we have conducted."
Conference Call Information
The Company will host an investor conference call and live webcast today, Monday, October 11, 2010 at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time. The conference call, live webcast and archived replay are open to all interested parties.
To access the conference call via the Internet, go to www.alexza.com, under the "Investor Relations" link. Please join the call at least 15 minutes prior to the start of the call to ensure time for any software downloads that may be required. Interested parties may also pre-register to avoid pre-call delays at theconferencingservice.com. A replay of the call will be available for two weeks following the event.
To access the live conference call via phone, dial 888-713-4217. International callers may access the live call by dialing 617-213-4869. The reference number to enter the call is 20601442.
The replay of the conference call may be accessed via the Internet, at www.alexza.com, or via phone at 888-286-8010 for domestic callers or 617-801-6888 for international callers. The reference number for the replay of the call is 36572489.<<
I've always wondered how much easier it would be to administer this to an agitated patient versus other delivery systems. How about a blow dart? But I didn't think that would be a factor in the approval process, only in its success in the marketplace. I wondered a little about the lung function issue, but figured it was something that could be dealt with, and the FDA would be OK with that. Wrong on two counts. But then there's the stability issue, too.
I never owned this, but had a chunk in my charity portfolio, figuring a pop on approval, with the contest ending before commercial reality set in. Oh, well.
Stock off 50%+
Cheers, Tuck |
