Alexza Pharmaceuticals Inc. and Valeant Pharmaceuticals International Inc. said Monday that the Food and Drug Administration failed to approve Adusuve Staccato, their inhaled treatment for agitation caused by schizophrenia or bipolar disorder.
Alexza shares plunged $1.55, or 52 percent, to $1.46 in morning trading after falling to a 52-week low of $1.35 earlier in the session. The shares had traded as high as $3.92 over the last year. Valeant shares rose 54 cents, or 2 percent, to $27.38.
The companies said the FDA is concerned about Adusuve Staccato's effects on the breathing capacity of patients. They said that in some early-stage clinical trials, patients who used the drug were not able to expel as much air. That side effect was observed in health subjects as well as people with chronic lung disease and asthma, and it also affected people who used the Staccato inhaler but took a placebo instead of the drug. They said there were no serious respiratory side effects observed in late-stage studies of the drug.
The FDA also had questions about studies related to manufacturing of Adusuve Staccato.
Alexza is based in Mountain View, Calif., and Valeant is headquartered in Mississauga, Ontario. The companies have been collaborating since February.
