drugs

Sycrest - asenapina

What is Sycrest?

Sycrest is a medicine that contains the active substance asenapine. It is available as white, round (5 and 10 mg) sublingual tablets. Sublingual tablets are tablets that are placed under the tongue, where they dissolve.

What is Sycrest used for?

Sycrest is used for the treatment of moderate to severe manic episodes (extremely euphoric mood) in adults (aged 18 or over) with bipolar disorder, a mental illness in which patients suffer from an excessively euphoric mood that alternates at periods of normal or depressed mood.

The medicine can only be obtained with a prescription.

How is Sycrest used?

The recommended dose of Sycrest when taken alone is 10 mg twice a day, one dose in the morning and one in the evening. This dose can be reduced to 5 mg twice a day based on the patient's response. If Sycrest is used in combination with another medicine to treat manic episodes, the dose should be 5 mg twice a day which can be increased to 10 mg twice a day if necessary. Sycrest tablets should not be chewed or swallowed. If used in combination with other medicines, Sycrest should be taken last. The patient should avoid eating or drinking for 10 minutes after taking the medicine.

How does Sycrest work?

The active substance in Sycrest, asenapine, is an antipsychotic medicine. It is known as an "atypical" antipsychotic in that it differs from the old antipsychotic drugs available since the 1950s. Its precise mechanism of action is unknown, but it binds to multiple receptors on the surface of nerve cells in the brain. This breaks down the signals transmitted between brain cells by "neurotransmitters", chemicals that allow nerve cells to communicate with each other. Sycrest is thought to work by blocking receptors of 5-hydroxytrypamine neurotransmitters (also called serotonin) and dopamine. Because these neurotransmitters are involved in bipolar disorder, Sycrest helps normalize brain activity, reducing the symptoms of the disease.

What studies have been carried out on Sycrest?

The effects of Sycrest were first tested in experimental models before being studied in humans.

Four main studies examined the use of Sycrest in manic episodes in bipolar disorder. In two of these studies, a total of 977 adult patients were given Sycrest, olanzapine (another antipsychotic drug) or placebo for three weeks. The other two studies had a longer duration: in one, Sycrest was compared with olanzapine (for nine weeks in patients from short-term studies); while the other was an additional 12-week study in which 326 patients previously treated with another drug (lithium or valproic acid) were given Sycrest or placebo. The main measure of effectiveness was the change in the Y-MRS score (Young Mania Rating Scale, a rating scale for manic pathology) observed in patients after three weeks. The Y-MRS scale assesses the severity of the symptoms of manic episodes on a scale from 0 to 60.

Sycrest has also been studied in patients with schizophrenia. The studies were short-term and long-term and conducted on patients treated with Sycrest, other drugs for schizophrenia (olanzapine, risperidone or haloperidol) or placebo.

What benefit has Sycrest shown during the studies?

Sycrest has been shown to be effective in treating manic episodes in patients with bipolar disorder. In the first short-term study, the Y-MRS score reduction after three weeks was 11.5 and 14.6 points for Sycrest and olanzapine, respectively, compared to 7.8 points for placebo. The reductions for the second short-term study were 10.8 and 12.6 points for Sycrest and olanzapine and 5.5 for placebo, respectively.

In the first long-term study, a reduction in the Y-MRS score of 12.9 points was observed in patients taking Sycrest compared to a reduction of 16.2 in olanzapine-treated patients. In the second long-term study the reduction in the Y-MRS score was 10.3 and 7.9 for Sycrest and placebo respectively after three weeks and 12.7 and 9.3 after 12 weeks.

Schizophrenia studies have not provided sufficient evidence of efficacy in the treatment of this disease.

What are the risks associated with Sycrest?

The most common side effects with Sycrest (seen in more than 1 patient in 10) are anxiety and drowsiness (drowsiness). For the full list of all side effects reported with Sycrest, see the Package Leaflet.

Sycrest should not be used in people who may be hypersensitive (allergic) to asenapine or any of the other ingredients.

Why has Sycrest been approved?

The CHMP decided that Sycrest's benefits are greater than its risks and recommended that it be given marketing authorization for the treatment of moderate to severe manic episodes in patients with bipolar disorder.

However, the CHMP has not recommended authorization of the drug in the treatment of schizophrenia due to the lack of efficacy demonstrated in this disease.

More information on Sycrest

On September 1, 2010, the European Commission issued a marketing authorization for Sycrest to NV Organon, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed.

For the full EPAR version, visit the Agency's website. For more information on Sycrest therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Last update of this summary: 07-2010.