Adasuve - Loxapine

What is Adasuve - Loxapine?

Adasuve is a medicine that contains the active substance loxapine. It is available as an inhalation powder contained in a single-use portable inhaler (4.5 mg and 9.1 mg).

What is Adasuve - Loxapine used for?

Adasuve is used for the rapid control of mild to moderate agitation in adults with schizophrenia or bipolar disorder. Schizophrenia is a mental illness characterized by several symptoms, including disorganized thinking and language, hallucinations (auditory or visual perception of non-existent things or people), distrust and delusions (erroneous beliefs). Bipolar disorder is a mental illness in which periods of good humor alternate with periods of depression. Agitation is a known complication of both of these mental illnesses.
The medicine can only be obtained with a prescription.

How is Adasuve used - Loxapine?

Adasuve should only be used in hospital under the supervision of healthcare professionals. For the treatment of patients who develop bronchospasm (excessive and prolonged contraction of the muscles of the airways), an airway-widening medicine called a short-acting beta agonist should also be available.

Treatment with Adasuve starts by inhaling a single dose of 9.1 mg. If deemed necessary, your doctor may prescribe a second dose of 9.1 mg after two hours. A lower dose of 4.5 mg. , may be prescribed if the patient has not tolerated the starting dose of 9.1 mg or if a lower dose is considered more appropriate. Patients should be monitored for signs of shortness of breath for one hour after each dose.
Information on how to use the inhaler can be found in the package leaflet.

How does Adasuve - Loxapine work?

The active substance in Adasuve, loxapine, is an antipsychotic medicine. In the brain, this principle binds to various receptors on the surface of nerve cells and blocks them. In this way, it interrupts the signals transmitted from one brain cell to the other by "neurotransmitters", chemicals that allow nerve cells to communicate with each other. Loxapine works primarily by blocking the receptors of the neurotransmitters 5-hydroxytryptamine (also called serotonin ) and dopamine. Since these neurotransmitters are involved in the agitation characteristic of schizophrenia and bipolar disorder, loxapine helps normalize brain activity by reducing agitation. Its action on the receptors of other neurotransmitters may also play a role.

How has Adasuve - Loxapine been studied?

The effects of Adasuve were first tested in experimental models before being studied in humans.
Adasuve has been studied in two main studies. One study involved 344 patients with schizophrenia and the second study involved 314 patients with bipolar disorder. Both studies compared 4.5 mg and 9.1 mg of Adasuve with placebo (a dummy treatment).
The main measure of effectiveness was the change in patients' symptoms two hours after administration of a dose of loxapine, as assessed using a standard agitation scale for patients with schizophrenia and bipolar disorder (positive and negative symptom scale , excitement component: PEC score). A reduction in the PEC score indicates an improvement in symptoms.

What benefit has Adasuve - Loxapine shown during the studies?

Adasuve was more effective than placebo in controlling agitation. In the study of patients with schizophrenia, subjects treated with 4.5 mg of Adasuve had a mean reduction in PEC score of 8.0 points and patients treated with 9 , 1 mg had a mean reduction of 8.7 points. In patients taking placebo, the reduction was 5.8 points. The study initiation PEC score for these patient groups ranged from 17 to 18 .
In the study of patients with bipolar disorder, patients treated with 4.5 mg of Adasuve had a mean reduction in PEC score of 8.2 points and patients treated with 9.1 mg had a mean reduction of 9.2 points . In patients taking placebo, the reduction was 4.7 points. The PEC score at study initiation for these patient groups ranged from 17 to 18.

What is the risk associated with Adasuve - Loxapine?

In studies of agitated patients, bronchospasm was reported as an uncommon but serious adverse reaction, while in subjects with active airway disease, bronchospasm was reported as common and often required treatment with a beta agonist. short-acting. The most common side effects of Adasuve are dysgeusia (taste disturbances), sedation or sleepiness and dizziness. For the full list of side effects reported with Adasuve, see the package leaflet.
Adasuve should not be used in individuals who are hypersensitive (allergic) to loxapine or any of the other ingredients. It should also not be used in patients with symptoms such as wheezing and shortness of breath or who have lung conditions such as asthma or chronic obstructive pulmonary disease.

Why has Adasuve - Loxapine been approved?

The CHMP concluded that Adasuve has been shown to rapidly (within minutes) control mild to moderate agitation in patients with schizophrenia or bipolar disorder who cooperate using an inhaler. The CHMP noted that the administration of Adasuve is non-invasive. Regarding the safety profile, most of the undesirable effects are comparable to those of other antipsychotic medicines. The potential risk of bronchospasm is considered manageable and was adequately addressed through risk reduction measures. The CHMP decided that the benefits of Adasuve exceed its risks and recommended that the medicine be given a marketing authorization.

What measures are being taken to ensure the safe use of Adasuve - Loxapine?

The company that makes Adasuve must ensure that all healthcare professionals who are expected to use Adasuve receive an information pack containing key information on how to use the medicine, as well as important safety information.

More information about Adasuve - Loxapine

On February 20, 2013, the European Commission issued a "Marketing Authorization" for Adasuve, valid throughout the European Union.
For the complete version of Adasuve's EPAR, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Adasuve therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 02-2013.


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