Alexza starts AZ-003 phase 1 clinical trial

By Elaine Rigoli

Tampa, Fla., April 26 - Alexza Pharmaceuticals, Inc. has started a phase 1 clinical trial with AZ-003 (Staccato fentanyl), an inhalation product candidate being developed for the treatment of patients with acute-pain episodes, including patients with breakthrough pain and postoperative patients.

The trial in about 50 healthy volunteers will be conducted at a single clinical center in two stages, the company said in a news release.

Stage 1 is an open-label, cross-over comparison of a single dose of AZ-003 and an equivalent dose of intravenous fentanyl.

Stage 2 is a randomized, double-blind, placebo-controlled dose escalation trail of AZ-003, evaluating multiple doses of fentanyl.

The three primary aims of the trial are to evaluate the pharmacokinetics and absolute bioavailability for AZ-003, to compare the AZ-003 pharmacokinetics profile to the IV fentanyl pharmacokinetics profile and to examine the tolerability and safety of AZ-003 in a non-opioid-tolerant, healthy volunteer population.

Alexza Pharmaceuticals is an emerging pharmaceutical company based in Palo Alto, Calif.

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