Schizophrenia.com

Teva Launches ADASUVE(R) in U.S


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The first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults

JERUSALEM–(BUSINESS WIRE)–March 03, 2014–

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announced today the commercial launch of ADASUVE® (loxapine) inhalation powder 10 mg, the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

ADASUVE® is administered through Alexza Pharmaceuticals’ (NASDQ:ALXA) innovative proprietary Staccato® single-use, hand held drug delivery technology system. This new drug-device combination product provides rapid systemic delivery by inhalation of a thermally-generated aerosol of loxapine, a first generation antipsychotic, to the lung. Administration of ADASUVE® results in rapid absorption of loxapine, with a maximum plasma concentration achieved in approximately 2 minutes.

Efficacy was demonstrated in two clinical trials in acute agitation: one in schizophrenia and one in bipolar I disorder. Patients receiving ADASUVE® experienced a statistically significant reduction in agitation at two hours, with an effect seen as early as ten minutes post-dose.

Due to the risk of bronchospasm that has the potential to lead to respiratory distress and respiratory arrest, ADASUVE® is contraindicated in patients with a current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other pulmonary disease associated with bronchospasm and is only available through a restricted program called the ADASUVE® Risk Evaluation and Mitigation Strategy (REMS).

http://online.wsj.com/article/PR-CO-20140303-906077.html