FDA Briefing Documents made available for PDAC meeting
However, despite the sponsor’s arguments, the Division remains concerned that the full extent and severity of pulmonary toxicity in the intended treatment population is unknown. In the pivotal trials (004-301 and 004-302), patients with clinically significant acute or chronic pulmonary disease were excluded, and in the pulmonary safety studies in healthy volunteers (004-104) and subjects with asthma (004-105), smokers were excluded. Furthermore, dosing interval in the pulmonary safety studies (004-104, 004105, and 004-108) was 8-10 hours (as opposed to the sponsor’s proposed 2 hour dosing interval in labeling), and subjects who experienced significant respiratory adverse events, received albuterol rescue, or had a decrease in FEV1 ≥20% after the first dose were ineligible to receive the second dose. Since decreases in FEV1 usually precede respiratory signs or symptoms, it is reasonable to conclude that some patients receiving dosing at 2 hour intervals in a clinical setting where frequent spirometry assessments are impractical (and who have unrecognized decreases in FEV1 after the first dose) would have more severe respiratory decompensation than observed in the pulmonary safety studies.
Source: FDA.gov. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMateria...
Alexza Announces the Adasuve(TM) (Staccato® Loxapine) PDAC Meeting Date of December 12, 2011
NDA Seeks Marketing Approval for ADASUVE for the Acute Treatment of Agitation in Adults with Schizophrenia or Bipolar I Disorder
MOUNTAIN VIEW, Calif., Oct. 24, 2011 /PRNewswire via COMTEX/ --
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the U.S. Food & Drug Administration (FDA) has scheduled a meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) for December 12, 2011, at which the ADASUVE New Drug Application (NDA) will be discussed. In August 2011, Alexza received notification that the FDA had accepted the resubmission of the ADASUVE NDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.
Source: press release, 10/24/11. http://phx.corporate-ir.net/phoenix.zhtml?c=196151&p=irol-newsArticle&ID...
|Adasuve (AZ-004)||Psychiatry||Schizophrenia (agitation)||Antipsychotic (typical)||Dopamine (D2/D3) receptor|
Mechanism of action: Adasuve ( AZ-004) is the combination of Alexza's proprietary Staccato system with loxapine, a drug belonging to the class of compounds known generally as antipsychotics. The Staccato system is a hand-held, chemically-heated, single dose inhaler designed to generate and deliver excipient-free drug aerosol for deep lung delivery that results in IV-like pharmacokinetics.
Phase of Development: Filed
Event Type: Regulatory FDA: Advisory Committee Meeting
DA Psychopharmacologic Drugs Advisory Committee Recommends Approval of Alexza's ADASUVE(TM)
Approval Recommendation Based Upon FDA REMS and One ADASUVE(TM) Dose in 24 Hours
MOUNTAIN VIEW, Calif., Dec. 13, 2011 /PRNewswire via COMTEX/ --Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) voted to recommend that ADASUVE(TM) (Staccato® loxapine) be approved for use as a single dose in 24 hours when used with the FDA recommended Risk Evaluation and Mitigation Strategy (REMS), for the treatment for agitation in patients with schizophrenia or bipolar mania. The vote on this question was 9/8/1 (yes/no/abstain).
Source: press release, 12/13/11. http://phx.corporate-ir.net/phoenix.zhtml?c=196151&p=irol-newsArticle&ID...