Teva Launches First Inhalable Antipsychotic Drug in U.S.

Adasuve reduces agitation in adults with schizophrenia or bipolar I disorder.

Teva Pharmaceutical Industries is launching the first orally inhaled medicine for treating agitation associated with adult schizophrenia or bipolar I disorder in the United States, the company announced on Monday.

Adasuve is administered with an innovative handheld aerosol device developed by Alexza Pharmaceuticals. Previous treatment options for the condition were limited to pills or injections, sometimes requiring the use of restraints.

Teva acquired the rights to the drug, the first of the new therapeutic entities that are a major part of the company’s growth strategy, last May for $40 million up-front and $195 million in milestone payments.

As many as five million patients with bipolar I disorder or schizophrenia in the U.S. experience and seek treatment for agitation episodes.

The drug's efficacy was demonstrated in two clinical trials on acute agitation, one associated with schizophrenia and the other with bipolar I disorder. Adasuve showed significant reduction in agitation at two hours, with an effect seen as early as ten minutes post-dose.

"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 Michael McHugh, vice president and general manager, Teva Select Brands and Teva Women's Health.

McHugh said the drug's launch was part of the company's "ongoing commitment to enhancing patient care and bringing new therapies and delivery systems to the market that fit within our areas of expertise."

Teva's headquarters in Jerusalem.
Bloomberg