Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today announced the commercial launch of Adasuve (loxapine) 10mg inhalation powder. Teva says that Adasuve is 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. Teva says that 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. Using Adasuve results in rapid absorption of loxapine, with a maximum plasma concentration achieved in about two 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 after use.
Due to the risk of bronchospasm that has the potential to lead to respiratory distress and respiratory arrest, Adasuve should not be used by patients with asthma, chronic obstructive pulmonary disease (COPD), or other pulmonary disease associated with bronchospasm. It is only available through a restricted program called the Adasuve Risk Evaluation and Mitigation Strategy (REMS), when used in a facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management.
Belmont Center for Comprehensive Treatment Philadelphia, Pennsylvania medical director for research and clinical trials Dr. Richard Jaffe who was a clinical trial investigator, said “Existing treatment options for patients with agitation associated with schizophrenia or bipolar I disorder are limited to oral tablets or injectable modes of administration, sometimes requiring the use of restraints. Adasuve is a drug-device combination that offers health care providers a new option to help manage agitation.”
Agitation associated with schizophrenia and bipolar I disorder is estimated to result in approximately 7 million episodes that end up in an acute emergency treatment setting each year. Acute agitation can increase in severity and escalate unpredictably.
Teva licensed the US commercial rights to Adasuve in May 2013 from Alexza Pharmaceuticals, inventor and developer of the Staccato system and of Adasuve itself. Under the terms of the license and supply agreement, Teva is responsible for all US commercial and clinical activities including US post-approval clinical studies. Alexza is responsible for manufacturing and supplying Adasuve to Teva for commercial sales and clinical trials.
Published by Globes [online], Israel business news - www.globes-online.com - on March 3, 2014
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