On Friday, Alexza Pharmaceuticals (NASDAQ: ALXA) and Grupo Ferrer International, S.A., announced that Europe's Committee for Medicinal Products for Human Use (CHMP) has issued a "positive opinion" recommending that their Adasuve anti-agitation drug be approved for sale in the European Union.
Specifically, CHMP recommended that Adasuve be authorized in the EU for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder, provided the drug is "administered only in a hospital setting under the supervision of a health care professional" and that drugs be kept at hand to deal with possible severe respiratory side effects. CHMP's ruling was based on clinical trial results that showed "statistically significant reductions in agitation from baseline compared to placebo."
CHMP's recommendation is not binding, and will now go to the European Commission, which will render a binding decision, probably in the first quarter of next year.
Alexza estimates that as many as 8 million adults in the EU suffer from schizophrenia or bipolar disorder; agitation is a common symptom for those people.
Shares of Alexza are up nearly 10% on the news, at $5.75 per share.