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Saphris (asenapine)

Company: Schering-Plough
Approval Status: Approved August of 2009
Treatment for: schizophrenia and manic or mixed bipolar 1 episodes
Areas: Psychiatry / Psychiatric

| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |


General Information

Saphris (asenapine) is a sublingual psychotropic agent. The exact mechanism of action is unknown. However, it has been suggested that the efficacy of asenapine in schizophrenia is mediated through a combination of antagonist activity at D2 and 5-HT2A receptors.

Saphris is specifically indicated for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.

Saphris is supplied as a tablet for sublingual administration.

The recommended initial dose of the drug for schizophrenia is as follows:
Usual Dose for Acute Treatment in Adults
The recommended starting and target dose of Saphris is 5mg given twice daily. The safety of doses above 10mg twice daily has not been evaluated in clinical studies.
Maintenance Treatment
There is no available evidence regarding how long the schizophrenic patient should remain on Saphris. It is generally recommended that responding patients be continued beyond the acute response.

The recommended initial dose of the drug for Bipolar Disorder is as follows:
Usual Dose for Acute Treatment in Adults:
The recommended starting dose of Saphris is 10mg twice daily. The dose can be decreased to 5mg twice daily if there are adverse effects. The safety of doses above 10mg twice daily has not been evaluated in clinical trials.
Maintenance Treatment
There is no available evidence regarding how long the bipolar patient should remain on Saphris. It is generally recommended that responding patients be continued beyond the acute response.


Clinical Results

FDA Approval
The FDA approval of Saphris was based on the following studies:

Schizophrenia
Three fixed-dose, short-term (6 week), randomized, double-blind, placebo-controlled, and active-controlled (haloperidol, risperidone, and olanzapine) trials enrolled adult patients who met DSM-IV criteria for schizophrenia and were having an acute exacerbation of their schizophrenic illness. The primary efficacy rating scale was the Positive and Negative Syndrome Scale (PANSS). The primary endpoint was change from baseline to endpoint on the PANSS total score.
Trial One
This study enrolled 174 subjects and compared Saphris (5 mg twice daily) to placebo, Saphris was statistically superior to placebo on the PANSS total score.
Trial Two
This trial enrolled 448 subjects and compared two fixed doses of Saphris (5mg and 10mg twice daily) to placebo. Saphris 5 mg twice daily was statistically superior to placebo on the PANSS total score. Saphris 10mg twice daily showed no added benefit compared to 5mg twice daily and was not significantly different from placebo.
Trial Three
Saphris could not be distinguished from placebo; however, an active control in this trial was superior to placebo.

Bipolar Disorder
Two similarly designed 3-week, randomized, double-blind, placebo-controlled, and active-controlled (olanzapine) trials enrolled adult patients who met DSM-IV criteria for Bipolar I Disorder with an acute manic or mixed episode with or without psychotic features. The subjects received placebo or Saphris, initially administered 10 mg twice daily. The dose could be adjusted within the dose range of 5 to 10 mg twice daily from Day 2 onward based on efficacy and tolerability. Ninety percent of patients remained on the 10 mg twice daily dose. Saphris was statistically superior to placebo on the YMRS total score and the CGI-BP Severity of Illness score (mania) in both studies.


Side Effects

Adverse events associated with the use of Saphris for schizophrenia may include, but are not limited to, the following:

  • Insomnia
  • Somnolence
  • Extrapyramidal symptoms
  • Akathisia
  • Constipation
  • Oral hypoesthesia
  • Vomiting
  • Dizziness

Adverse events associated with the use of Saphris for bipolar disorder may include, but are not limited to, the following:

  • Somnolence
  • Headache
  • Dizziness
  • Extrapyramidal symptoms
  • Insomnia
  • Weight increased


Mechanism of Action

Saphris (asenapine) is a sublingual psychotropic agent. The exact mechanism of action is unknown. However, it has been suggested that the efficacy of asenapine in schizophrenia is mediated through a combination of antagonist activity at D2 and 5-HT2A receptors.


Literature References

Marston HM, Young JW, Martin FD, Serpa KA, Moore CL, Wong EH, Gold L, Meltzer LT, Azar MR, Geyer MA, Shahid M Asenapine effects in animal models of psychosis and cognitive function. Psychopharmacology 2009 May 22

FrÄnberg O, Marcus MM, Ivanov V, Schilström B, Shahid M, Svensson TH Asenapine elevates cortical dopamine, noradrenaline and serotonin release. Evidence for activation of cortical and subcortical dopamine systems by different mechanisms. Psychopharmacology 2009 Jun;204(2):251-64

Potkin SG, Cohen M, Panagides J Efficacy and tolerability of asenapine in acute schizophrenia: a placebo- and risperidone-controlled trial. The Journal of Clinical Psychiatry 2007 Oct;68(10):1492-500


Additional Information

For additional information regarding Saphris or schizophrenia and manic or mixed bipolar 1 episodes, please visit the Saphris web page.




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Saphris Drug Information

The Saphris drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.





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