The Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) voted to recommend that ADASUVE(TM) (Staccato® loxapine) be approved for use as a single dose in 24 hours. It should be used alongside the FDA recommended Risk Evaluation and Mitigation Strategy (REMS), when patients with schizophrenia or bipolar mania are exhibiting symptoms of agitation.
In Europe the European Medicines Agency (EMA) is processing an application of the drug’s use and will follow their Centralized Procedure.
Thomas B. King, President and Chief Executive Officer of Alexza Pharmaceuticals manufacturer of ADASUVE said :
“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.”
The FDA takes the PDAC’s recommendations under advisement when reviewing the new drug application, but the committee’s recommendations are not binding. The committee discussed ADASUVE and studied the available data and voted on a series of questions :
- Does the committee conclude that ADASUVE (loxapine) inhalation powder has been shown to be effective as a treatment for agitation in patients with schizophrenia or bipolar mania? The resulting vote was: 17/1/0 (yes/no/abstain)
- Does the committee conclude that ADASUVE (loxapine) inhalation powder has been shown to be acceptably safe for use as a treatment for agitation in patients with schizophrenia or bipolar mania:
a. When used in conjunction with the REMS proposed by the sponsor? The resulting vote was: 1/17/0 (yes/no/abstain).
b. When used in conjunction with the REMS proposed by the FDA? The resulting vote was: 5/12/1 (yes/no/abstain).
- Does the committee conclude that ADASUVE (loxapine) inhalation powder would be acceptably safe for use as a single dose in 24 hours as a treatment for agitation in patients with schizophrenia or bipolar mania:
a. When used in conjunction with the REMS proposed by FDA? The resulting vote was: 11/5/2 (yes/no/abstain).
- Does the committee conclude that ADASUVE (loxapine) inhalation powder should be approved for use as a single dose in 24 hours when used with the FDA recommended REMS, for the treatment for agitation in patients with schizophrenia or bipolar mania. The resulting vote was: 9/8/1 (yes/no/abstain).
People with serious psychiatric disorders, including schizophrenia, which affects approximately 2.4 million adults in the United States, and bipolar disorder, which affects approximately 5.7 million adults in the United States, often suffer from agitation.
It is estimated that more than 90% of those diagnosed with these problems will experience a form of agitation at one point or another in their lives. It is important to treat agitation, although it might start as a relatively minor tick, over a short period of time it can escalate and amplify the patients general symptoms.
Starting as a simple restless or tense mood or uncomfortable feeling, as the agitation intensifies the behavior becomes more noticeable to people around the patient, and can increase to threatening and even violent episodes. Patients exhibiting these problems are normally treated with antipsychotics and / or benzodiazepines in oral or intramuscular injection preparations. However, there are no non-invasive therapies that work within 30 minutes to help agitated patients in need of treatment.
ADASUVE is an anti-agitation product that combines Alexza’s Pharmaceuticals, Inc proprietary Staccato system with loxapine. loxapine is an antipsychotic currently available in the U.S. as an oral formulation for the management of schizophrenia. The Staccato system is a hand-held, single-dose inhaler that delivers a medication comparable to intravenous administration, but with greater ease, patient comfort and convenience. In clinical studies, ADASUVE has shown an onset of effect in 10 minutes of dosing, which is the first time point measured in the Phase 3 clinical studies. The ADASUVE NDA contains efficacy and safety data from more than 1,600 patients and subjects, who have been studied in thirteen different clinical trials.
Written by Rupert Shepherd