EMA Panel Recommends Approval of Loxapine for Agitation

Caroline Cassels

December 14, 2012

An advisory panel to the European Medicines Agency (EMA) has recommended the approval of loxapine (Adasuve, Alexa UK Ltd) for the rapid control of agitation in adult patients with bipolar disorder or schizophrenia.

On Thursday, the Committee for Medicinal Products for Human Use announced it had adopted a positive opinion on the drug and recommended that it be granted marketing authorization.

A psycholeptic antipsychotic, its efficacy is thought to be mediated through high-affinity antagonist of dopamine D2 receptors and serotonin 5-HT2A receptors.

Loxapine binds with noradrenergic, histaminergic, and cholinergic receptors. Its interaction with these systems may influence the spectrum of its pharmacologic effects associated with calming effects and suppression of aggressive behavior.

According to the committee's written opinion, the benefits of the drug are its "ability to rapidly reduce the agitation in mild to moderate patients with schizophrenia or bipolar disorder. In these patients decreased agitation was evident 10 minutes after the first dose, the first assessment time, and at all subsequent assessments during the 24 hour evaluation period, both for the 4.5 mg and 9.1 mg doses. About a quarter to nearly half of the patients needed a second dose after 2 hours to reach a satisfactory effect."

The most common side effects of the drug include dysgeusia, sedation/somnolence, and dizziness. Bronchospasm was reportedly uncommon, but in individuals with active airways disease, it was commonly reported and often required treatment with a short-acting beta-agonist bronchodilator.

The committee notes that a "pharmacovigilance plan" for the drug will be implemented as part of the marketing authorization.