End of February, the European Medicines Agency EMA has approved the first inhalant antipsychotic medication, Adasuve. The FDA had approved it already in December 2012. Manufacturer is the American company Alexza Pharmaceuticals, sales in Europe takes the Spanish Ferrer Group. The approval covers the “rapid control of mild to moderate agitation in adults with schizophrenia or bipolar disorder”.Adasuve is a combination of the staccato system developed by Alexza – an inhalant system for the release of a drug aerosol in the lungs – and the antipsychotic loxapine. Loxapine is a tricyclic antipsychotic drug that has been in use in the U.S. for many years. The substance belongs to the class of the first-generation antipsychotics, although some authors attribute “atypical” properties to it. As most tricyclic antipsychotics, loxapine is not selective for D2 dopamine receptors. It also antagonizes histamine H1, α1-and acetylcholine receptors. Thus, all adverse effects that one can expect from a substance with these characteristics are also seen with loxapine treatment.
Adasuve can be administered in two dosages. With inhalation of 5 mg of the substance, 4.5 mg loxapine reach the patient, administration of 10 mg leads to an effective dose of 9.1 mg loxapine (oral doses of loxapine are up to 50 mg per capsule). Treatment typically starts with the higher dosage. The administration is strictly regulated: It may only take place in a hospital under the supervision of medical staff. Because of possible bronchospasms, which were observed under the treatment with adasuve, a short-acting bronchodilator beta-sympathomimetic must be available. Patients should be observed for symptoms of bronchospasm for up to one hour after administration of adasuve. When a first dose of Adasuve is not effective, a second dose may be administered after two hours. More than two doses should not be given. After treatment with adasuve patients should receive regular treatment.
Brochospasms during treatment are relatively rare. In patients with asthma or chronic obstructive pulmonary disease the occurrence of this complication is more frequent.
The effect of adasuve occurs very rapidly, within ten minutes. Thus, the effectiveness occurs so quickly as with intravenous administration of an antipsychotic. Maximum plasma concentrations are measured after two minutes (Spyker et al., 2010). The approval is based on two double-blind, placebo-controlled trials in more than 300 patients each, one in patients with schizophrenia (Lesem et al., 2011; n = 344) and one in patients with bipolar disorders (Kwentus et al., 2012; n = 314).
According to the manufacturers, adasuve will be available both in the U.S. and in Europe in the 3rd Quarter of 2013. In Germany, adasuve will be marketed by Trommsdorff, belonging to the Ferrer group. The price is not yet known.
This post is also available in: German