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Alexza's Adasuve May Not Be Ready For FDA Approval
Something I wonder about is how many of the acutely agitated patients will actually be suitable candidates for this drug. As I understand it, the pivotal studies required patient consent and therefore selected for individuals who could be instructed in how to use the inhaler and who were motivated to comply.
Many of the patients I have seen with acute agitation presented in the ER in a paranoid, aggressive state or created chaos in hospital wards in the middle of the night throwing furniture through windows. There is just no way that Adasuve would be an option for patients like this.
The overall market also seems potentially very small. I read a study (admittedly it was a few years old) that claimed there were ~1M ER admissions for psychotic episodes per year in the US. Additional episodes may occur in different settings but the numbers are hardly overwhelming.
Dec 11 05:38 PM
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