Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product ...(azine). Alexza is developing AZ-001 totr...),Health

-- AZ-104 (Staccato loxapine). Alexza is developing AZ-104 to treat patients suffering from acute migraine headaches. AZ-104 is a lower dose version of AZ-004. In March 2008, the Company announced initial results of an in-clinic, multi-center randomized, double-blind, single administration, placebo controlled Phase 2a proof-of-concept clinical trial in 168 migraine patients with or without aura. Three doses of AZ-104 (1.25, 2.5 and 5 mg) were evaluated against placebo in the clinical trial. Using the IHS 4-point rating scale, the primary efficacy endpoint was pain-relief response at 2 hours post-administration. AZ-104 met the primary efficacy endpoint of the clinical trial for the two highest doses of the drug compared to placebo. Statistically significant improvements in pain response were observed in 76.7% of patients at the 5 mg dose (p= 0.02), 79.1% of patients at the 2.5 mg dose (p = 0.01) and 67.4% of patients at the 1.25 mg dose (p = 0.18), compared to 51.3% of patients receiving placebo. Using survival analysis for pain relief response, all three dose groups were statistically superior (p < 0.05) to placebo during the 4-hour post-treatment time period that the patients remained in the clinic.

Alexza's original IND for Staccato loxapine was filed with the Division of Neuropharmacological Drug Products of the FDA. In July 2005 the FDA reorganized this division into two new divisions, the Division of Psychiatry Products, or DPP, and the Division of Neurology Products, or DNP. The Staccato loxapine IND was transferred to the DPP, as the AZ-004 development program is for a psychiatric indication. Under that IND, Alexza was allowed to conduct the first patient study in migraine patients, the Phase 2a proo
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