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Alexza Pharmaceuticals, Inc.

Alexza initiates AZ-003 phase I clinical trial for anti-pain drug

Published in Pharma Law Weekly, May 23rd, 2006

Alexza Pharmaceuticals, Inc., (ALXA) announced that it has initiated a phase I clinical trial with AZ-003 (Staccato fentanyl).

AZ-003 is an inhalation product candidate being developed for the treatment of patients with acute pain episodes, including patients with breakthrough pain and postoperative patients.

The phase I clinical trial in approximately 50 healthy volunteers will be conducted at a single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a single dose of AZ-003 and an equivalent dose of intravenous (IV) fentanyl. Stage 2 is a randomized, doubleblind, placebo-controlled dose escalation trail of AZ-003,...

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