After meeting to discuss concerns about the safety of Alexza Pharmaceutical’s Adasuve Staccato loxapine, the FDA’s Psychopharmacologic Drugs Advisory Committee voted 9 to 8, with 1 abstention, to recommend approval for a single dose in 24 hours when used with the FDA-recommended Risk Evaluation and Mitigation Strategy (REMS), for the treatment for agitation in patients with schizophrenia or bipolar mania.
The committee voted 17 to 1 in favor on the question of Adasuve’s efficacy, but 17 to 1 against on the question of whether the product is acceptably safe if used with Alexza’s proposed REMS. Only 5 members of the committee agreed that the product would be safe if used with the FDA’s proposed REMs unless the dose was limited to 1 in 24 hours, a proposal that received 11 votes in favor, 5 against, and 2 abstentions.
“We view the recommendations by the PDAC today as another step forward in the development of Adasuve. We appreciate the Advisory Committee’s recognition of agitation as a serious and underappreciated symptom of schizophrenia and bipolar disorder. If approved, we believe Adasuve represents a valuable treatment option for patients and physicians alike. We look forward to continuing to work toward our goal of bringing Adasuve to market in 2012,” commented Alexza President and CEO Thomas B. King.
The Adasuve NDA Prescription Drug User Fee Act (PDUFA) goal date is February 4, 2012. The company filed an MAA in Europe earlier this year, and the application is under review. The Staccato system heats the drug, creating a condensation vapor from pure API for inhalation.
Read the Alexza press release.
