|Alexza's Staccato device--Courtesy of Alexza|
Teva Pharmaceutical Industries ($TEVA) launched its Adasuve inhaled powder for the treatment of agitation associated with schizophrenia and bipolar I disorder in the U.S. The drug is the first of its kind with this delivery system, which uses Alexza Pharmaceuticals' ($ALXA) Staccato device for absorption in the lungs.
Adasuve, which is a powdered version of loxapine, is currently the only orally inhaled treatment for these symptoms, using a fast onset of about two minutes to curb an episode of agitation in patients with these conditions.
"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," clinical trial investigator Richard Jaffe said in a statement. "Adasuve is a drug-device combination that offers healthcare providers a new option to help manage agitation."
Alexza's Staccato system is a single-use device that uses a heat system coated with a drug. When a patient inhales normally, the surface heats to create a condensation aerosol, according to the company. The size of the particles themselves also helps the drug reach deep into the lungs, where absorption is more complete.
The launch marks the first time Alexza has brought a Staccato product from development into approval and manufacturing scale-up in the U.S., CEO Thomas King said in a statement. Adasuve, which Israel's Teva licensed in May 2013, has been available in Germany since July 2013.
The FDA approved Alexza's Adasuve in December 2012 before Teva's involvement, but only after a rejection based on manufacturing deficiencies earlier in the year. At the time, analysts predicted the drug could be worth $207 million in U.S. sales in 2016. And not a moment too soon: The Mountain View, CA-based company was getting low on cash.
Adasuve comes off two Phase III trials that showed significant improvement in agitation at two hours, according to Teva, with a 49% reduction in agitation symptoms in schizophrenia patients (33% with a placebo) and 53% reduction in bipolar I patients (27% in placebo). And at only 10 minutes after administration, symptoms fell off 19% and 23% for each of the conditions.
"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," Teva VP and general manager Michael McHugh said in a statement.
- here's Teva's release
- and Alexza's release