What is Sycrest?
Sycrest is a medicine that contains the active substance asenapine. It is available as white, round sublingual tablets (5 and 10 mg). Sublingual tablets are tablets that are placed under the tongue, where they dissolve.
What is Sycrest used for?
Sycrest is used to treat moderate to severe manic episodes (extremely high mood) in adults (aged 18 years and over) with bipolar disorder, a mental illness in which patients have an alternating excessively high mood. to 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 daily 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. When 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 older 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 disrupts signals. transmitted between brain cells by 'neurotransmitters', chemicals that allow nerve cells to communicate with each other. Sycrest is believed to work by blocking the neurotransmitter 5-hydroxytrypamine (also called serotonin) and dopamine receptors. Bipolar disorder, Sycrest helps normalize brain activity, reducing the symptoms of the disease.
How has Sycrest been studied?
The effects of Sycrest were first tested in experimental models before being studied in humans.
Four main studies looked at the use of Sycrest in manic episodes in bipolar disorder. In two of these studies, a total of 977 adult patients were given either Sycrest, olanzapine (another antipsychotic drug) or placebo for three weeks. The others. 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 previously treated patients with another drug (lithium or valproic acid) Sycrest or placebo was given. The main measure of effectiveness was the change in the Young Mania Rating Scale (Y-MRS) score observed in the patients after three weeks. The Y-MRS scale evaluates the severity of symptoms of manic episodes on a scale of 0 to 60.
Sycrest has also been tested in patients with schizophrenia. The studies were short- and long-term and conducted in 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 reduction in Y-MRS score after three weeks was 11.5 and 14.6 points for Sycrest and olanzapine, respectively, compared with 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 Y-MRS score of 12.9 points was observed in patients taking Sycrest compared with a reduction of 16.2 in patients taking olanzapine. In the second long-term study, the reduction in Y-MRS score was 10.3 and 7.9 for Sycrest and placebo after three weeks and 12.7 and 9.3 after 12 weeks, respectively.
Studies on schizophrenia 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 in 10 patients) are anxiety and sleepiness (drowsiness). For the full list of side effects reported with Sycrest, see the Package Leaflet.
Sycrest must not be used in people who are 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 grant marketing authorization for the treatment of moderate to severe manic episodes in patients with bipolar disorder.
However, the CHMP did not recommend authorization of the drug in the treatment of schizophrenia due to the lack of efficacy demonstrated in this disease.
Learn more about Sycrest
On 1 September 2010, the European Commission issued the N.V. Organon is a "marketing authorization" for Sycrest, valid throughout the European Union. The "marketing authorization" is valid for five years, after which it can be renewed.
For the full version of the EPAR, visit the Agency's website. For more information on Sycrest therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 07-2010.
Sycrest information published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
