Alexza updates on the five post-EMA approval studies for Adasuve
US drugmaker Alexza Pharmaceuticals (Nasdaq: ALXA) has provided an update on its European Medicines Agency post-approval studies for its antipsychotic drug candidate Adasuve inhalation powder, pre-dispensed (Staccato loxapine).
The drug is under development for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. As part of the Adasuve approval process with the EMA, Alexza is required to conduct five post-approval studies:
- a benzodiazepine interaction study - study completed and data submitted to the EMA;
- a controlled study to determine Adasuve’s effect on cardiac rhythms, or a thorough QTc study, with two doses of Adasuve - study completed and data submitted to the EMA;
- a clinical program designed to evaluate the safety/efficacy of Adasuve in agitated adolescent patients - the initial study in this program, a Phase I dose-ranging study, has been initiated in collaboration with Teva and the first patient dosed;
- a Post-Authorization Safety Study (PASS) - study has been initiated and the first patient dosed; and
- a Drug Utilization Study (DUS) - study planned to be initiated in fourth-quarter 2014.
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