Adasuve is administered through Alexza Pharmaceuticals’ Staccato single-use, hand held drug delivery technology system.
The 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.
According to the company, administration of Adasuve results in rapid absorption of loxapine, with a maximum plasma concentration achieved in about two minutes.
The efficacy of loxapine was showed in two clinical trials in acute agitation: one in schizophrenia and one in bipolar I disorder.
The trials showed that patients receiving Adasuve experienced reduction in agitation at two hours, with an effect seen as early as ten minutes post-dose.
Adasuve is contraindicated in patients with a current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other related pulmonary disease associated with bronchospasm, due to the risk of bronchospasm that has the potential to lead to respiratory distress and respiratory arrest.
The drug is only available through a restricted program called the Adasuve Risk Evaluation and Mitigation Strategy (REMS).
It 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.
Teva Select Brands and Women’s Health vice president and general manager Michael McHugh said 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.
"As part of our ongoing commitment to enhancing patient care and bringing new therapies and delivery systems to the market that fit within our areas of expertise, Teva is pleased to launch this new treatment choice that is aligned with Teva’s New Therapeutic Entities (NTE) program," McHugh said.