|View printer-friendly version|
|March 03, 2014 8:15 a.m.|
|Teva Launches ADASUVE® in U.S.|
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
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). ADASUVE® must be administered only in a REMS-enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation).
“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
Patients experiencing agitation associated with schizophrenia or bipolar I disorder often manifest behaviors that interfere with their care, such as threatening behaviors, escalating or urgently distressing behavior or self-exhausting behavior that lead clinicians to use rapidly absorbed antipsychotic medications to help control the agitation quickly. 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.
“The availability of orally inhaled ADASUVE® provides a rapid
onset of action that quickly improves symptoms for patients and gives
providers in enrolled hospitals another treatment choice,” said
Two phase three short-term clinical efficacy trials demonstrated significant improvement in agitation at two hours, in patients with schizophrenia or bipolar I disorder treated with ADASUVE®. These studies demonstrated a 49 percent reduction in agitation symptoms from baseline in schizophrenia patients, as compared to 33 percent in placebo, and 53 percent reduction in bipolar I patients, as compared to 27 percent in placebo. Improvement was rapidly achieved at 10 minutes post-dose with a 19 percent reduction in agitation symptoms from baseline in schizophrenia patients and a 23 percent reduction in bipolar I patients, both as compared to 10 percent in placebo.
Please see additional important safety information including boxed warnings and REMS Program information below. The most common adverse reactions (greater than at least 2% in the treated group and greater than in the placebo group) in short-term, placebo-controlled trials were dysgeusia (abnormal taste), sedation and throat irritation.
Teva licensed the U.S. commercial rights to ADASUVE® in
ADASUVE® Prescribing Information
Please click here for Full Prescribing Information, including Boxed Warning.
INDICATION AND USAGE
ADASUVE® (loxapine) inhalation powder, for oral inhalation use, is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Efficacy was demonstrated in two trials in acute agitation: one in schizophrenia and one in bipolar I disorder.
Limitations of Use: As part of the ADASUVE® REMS Program to mitigate the risk of bronchospasm, ADASUVE ® must be administered only in an enrolled healthcare facility.
IMPORTANT SAFETY INFORMATION
WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation). Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE.
Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS.
Increased Mortality in Elderly Patients With Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psychosis.
ADASUVE® and Staccato® are registered trademarks
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations. Such statements involve a
number of known and unknown risks and uncertainties that could cause our
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential generic versions); the possibility of material fines,
penalties and other sanctions and other adverse consequences arising out
of our ongoing FCPA investigations and related matters; our ability to
achieve expected results from the research and development efforts
invested in our pipeline of specialty and other products; our ability to
reduce operating expenses to the extent and during the timeframe
intended by our cost reduction program; our ability to successfully
pursue and consummate suitable acquisitions or licensing opportunities;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.