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news.Alexza Pharmaceuticals, a specialty pharmaceutical company, has initiated a Phase IIb clinical trial with AZ-104 in patients with migraine headaches.
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The AZ-104 Phase IIb clinical trial is an outpatient, multi-center, randomized, double-blind, single-dose, placebo-controlled study in approximately 360 patients who have migraines, with or without aura. Approximately three doses will be evaluated in the clinical trial, placebo and two doses of AZ-104 (1.25 and 2.5mg).
The primary efficacy endpoint for the trial is headache pain relief at two hours post-dose, using the standard four-point rating scale. Secondary efficacy endpoints for the trial include pain relief and other symptom assessments at various time points. Safety evaluations will also be made throughout the clinical trial period.
AZ-104 is a lower-dose version of AZ-004 (Staccato loxapine), Alexza’s lead product candidate that is in late Phase III clinical development for the acute treatment of agitation in patients with schizophrenia or bipolar disorder.
Thomas King, president and CEO of Alexza, said: We believe the potential value of the non-invasive nature and rapid onset of pharmacological action provided by our Staccato system is well-suited for migraine pain relief in the outpatient setting. Data from this outpatient clinical trial will guide our future development plans for AZ-104 for the treatment of migraine headaches.