Alexza Pharmaceuticals 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 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, evaluating multiple doses of fentanyl.