Skip to main content

EMA Panel Recommends Approval of Loxapine for Agitation


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.

Comments

Post a Comment

Popular posts from this blog

Early Surgery for Sigmoid Volvulus May be Safe and Effective

August 29, 2012 — Early elective surgery for sigmoid volvulus should be encouraged because it is associated with lower morbidity and mortality, as well as a lower incidence of recurrence, than conservative treatment, according to the findings of a retrospective study. Omid Yassaie, MBChB, from Tauranga Hospital in New Zealand, and colleagues presented their findings in an article published online August 24 in the ANZ Journal of Surgery. The authors remark that the optimal treatment of sigmoid volvulus and the long-term prognosis of patients after treatment are unclear. "Sigmoidoscopic treatment has gained favour as it is less invasive than surgery; however, a significant portion of patients return with recurrent volvulus," the authors write. "There is little, if any data in New Zealand or Australia on long-term follow-up of sigmoid volvulus." The authors analyzed 57 patients (from a total of 84 admissions for sigmoid volvulus) who were admitted to the Department o…
Post a Comment
Read more

Secondary Prevention: Clinical Approaches to Managing the Higher-Risk Patient with Heart Disease

INCIDENCE/PREVALENCE/BURDENS ASSOCIATED WITH CARDIOVASCULAR DISEASE (CVD) The prevention of an initial and recurrent cardiovascular event and other complications, such as diabetes and kidney failure [also known as end-stage renal disease (ESRD) or chronic kidney disease (CKD) stage 5] is an important goal in patients with a history of CVD. Each year, approximately 185,000 Americans suffer a recurrent stroke, approximately 470,000 will have a recurrent coronary attack, and an estimated 325,000 will suffer a recurrent myocardial infarction.[1] Secondary prevention strategies offer the opportunity to prevent further complications and improve outcomes by early detection and management of common comorbidities. The burden on public health and the costs associated with chronic illnesses such as CVD, CKD, and diabetes remain high. An estimated 82.6 million American adults (1 in 3) have 1 or more types of CVD.[1] Heart failure is the fastest-growing clinical cardiac disease entity in the Unit…
Post a Comment
Read more

Sexsomnia: Clinical Analysis of an Underdiagnosed Parasomnia

Introduction Sexsomnia, also known as sleep sex or somnambulistic sexual behavior, refers to unintentional sexual behaviors or activities during sleep. Sexsomnia is a relatively new diagnosis. The term was coined by Shapiro and colleagues in 2003,[1] but cases of this condition have been reported in the literature for the past 3 decades.[2,3] Sexual behavior during sleep automatism can range from explicit vocalizations to touching or sexual intercourse, and in some cases even sexual assault or rape. It is non-rapid eye movement (NREM) parasomnia characterized by abnormal transitions between sleep and wake states. The second edition of the International Classification of Sleep Disorders (ICSD-2) discusses somnambulistic sexual activity in the context of disorders of arousal from NREM sleep.[4] Most commonly, NREM parasomnias arise from slow-wave sleep (SWS). Because of a relative lack of cortical control, partial arousals from this deep state of sleep can lead to uninhibited manifesta…
Post a Comment
Read more