Lundbeck are about to circulate this drug in Europe. What you need to know, your doctor hasn’t a clue about and your psychiatrist will deny..
Danish drugmaker Lundbeck A/S (LUND: DC) announced a worldwide commercialization agreement with US drugs giant Merck & Co (NYSE: MRK) for the latter’s antipsychotic drug Sycrest (asenapine) sublingual tablets (5mg, 10mg).
Under the terms of the deal, Lundbeck will pay an undisclosed fee as well as product supply payments in exchange for exclusive commercial rights to the drug in all markets outside the USA, China and Japan, which Merck will retain. Lundbeck expects to launch Sycrest in the European Union, where it is already approved, at the beginning of 2011. Merck has launched asenapine in the USA under the brand name Saphris.
Here what it says in the official FDA website and what probably wont be mentioned in the Irish version..
The possibility of a suicide attempt is inherent in psychotic illnesses and bipolar disorder, and close supervision of high-risk patients should accompany drug therapy. Prescriptions for Saphris should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose.
Adverse Reactions Associated with Discontinuation of Treatment: Approximately 16% (25/158) of Saphris-treated patients discontinued treatment due to an adverse reaction, compared with about 11% (18/166) on placebo. The most common adverse reactions associated with discontinuation in subjects treated with Saphris (rates at least 1% and at least twice the placebo rate) were depression (2.5%), suicidal ideation (2.5%), bipolar 1 disorder (1.9%), insomnia (1.9%) and depressive symptoms (1.3%).
Cardiac disorders: ≥1/1000 patients and <1/100 patients: tachycardia, temporary bundle branch block
Pregnancy Category C: There are no adequate and well-controlled studies of Saphris in pregnant women. In animal studies, asenapine increased post-implantation loss and decreased pup weight and survival at doses similar to or less than recommended clinical doses. In these studies there was no increase in the incidence of structural abnormalities caused by asenapine. Saphris should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery
The effect of Saphris on labor and delivery in humans is unknown.
Asenapine is excreted in milk of rats during lactation. It is not known whether asenapine or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Saphris is administered to a nursing woman. It is recommended that women receiving Saphris should not breast feed.
The most common adverse reactions (≥5% and at least twice the rate of placebo) reported with acute treatment in schizophrenia were akathisia, oral hypoesthesia, and somnolence.
Akathisa, also spelled acathisia, is a medical term used to describe “inner restlessness,” often in response to taking certain types of medications designed to treat psychiatric conditions. It may also occur in people with certain disorders like Parkinson’s disease, or be the result of certain conditions like the manic or hypomanic phase of bipolar-I and II. Often, akathisia is linked to use of anti-psychotics but recent studies also link it to use of some anti-depressants of the SSRI class (selective serotonin reuptake inhibitors). Some doctors suggest that akathisia resulting from SSRI use may be creating greater suicidality among patients who experience it.
Akathisa is the condition associated with causing suicidal and/or homicidal behavior.
Death can come suddenly without warning: antipsychotic SAPHRIS study pending for kids…LINK.