Lundbeck and sycrest (saphris)

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..

Suicide

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

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.

Nursing Mothers

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.

WARNING:

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.

One thought on “Lundbeck and sycrest (saphris)

  1. Comment:
    i just came across your blog while looking for saphris information. i’m unclear what you are describing here–are you saying saphris is associated with suicide? my understanding is that’s a (very) small possibility with most all similar drugs in this class. it sounds like the information is saying suicide is an innate possibility in the disease of schizophrenia, not necessarily from the drug.

    i know a lot of these drugs have bad side effects, but then there’s the flip side that they help people. my sis can’t function without her meds.
    please clarify your point, if possible. thanks!

    REPLY
    Hi…you didn’t leave any information so I can’t address you by name,
    YES… unfortunately that’s exactly what I’m saying and I’m so glad that your sister’s medication is working for her. The point I am trying to make is that all medications have side-effects and for the questionable percentage that they don’t work for…the consequences can be disastrous and sometimes fatal!
    My blog is about my ramblings, my son, my opinion, facts and side effects of medication available in other countries and not in Ireland, and Failure to warn from pharmaceutical companies and lundbeck in particular!
    Saphris/ sycrest is currently being launched by lundbeck in the E.U.

    This company cannot be trusted.
    They have lied to the Irish people; they have been investigated by the U.N. commission in the UN oil-for-food scandal, anticompetitive behavior, and have lied about their drug being licensed in other countries to get them approved in other parts of the world. Oh…and their drug pentobarbital is currently being used to execute people in the U.S.

    The facts are above…There are NO adequate studies of Saphris in pregnant women but it’s recommended that women receiving Saphris should not breast feed??

    Side effects include among others… Cardiac disorders and weight gain which lead to more problems but Hey…I’m sure there is a pill for that too.
    The most common side effect (5%) is akathisia. See above.

    Then there is elderly patients…

    WARNING: INCREASED MORTALITY IN
    ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
    Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5 percent, compared to a rate of about 2.6 percent in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. SAPHRIS® (asenapine) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].

    I hope I have answered your question.
    Leonie

    Like

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