Prolixin (Fluphenazine Decanoate) - Summary

PROLIXIN SUMMARY

PROLIXIN^® ORAL CONCENTRATE
Fluphenazine Hydrochloride Oral Solution USP

Prolixin Decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. It is a highly potent behavior modifier with a markedly extended duration of effect. Prolixin Decanoate is available for intramuscular or subcutaneous administration, providing 25 mg fluphenazine decanoate per mL in a sesame oil vehicle with 1.2% (w/v) benzyl alcohol as a preservative. At the time of manufacture, the air in the vials is replaced by nitrogen.

PROLIXIN (fluphenazine) is indicated for the following:

Prolixin Decanoate (Fluphenazine Decanoate Injection) is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics).

Prolixin Decanoate has not been shown effective in the management of behavioral complications in patients with mental retardation.

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NEWS HIGHLIGHTS

Media Articles Related to Prolixin (Fluphenazine)

Minimal Relationship Between Cannabis And Schizophrenia Or Psychosis Suggested By New UK Study
Source: Schizophrenia News From Medical News Today [2009.10.24]
Last year the UK government reclassified cannabis from a class C to a class B drug, partly out of concerns that cannabis, especially the more potent varieties, may increase the risk of schizophrenia in young people. But the evidence for the relationship between cannabis and schizophrenia or psychosis remains controversial. A new study has determined that it may be necessary to stop thousands of cannabis users in order to prevent a single case of schizophrenia.

Unlocking Mysteries Of The Brain With PET
Source: MRI / PET / Ultrasound News From Medical News Today [2009.11.04]
Inflammatory response of brain cells-as indicated by a molecular imaging technique-could tell researchers more about why certain neurologic disorders, such as migraine headaches and psychosis in schizophrenic patients, occur and provide insight into how to best treat them, according to two studies published in the November issue of The Journal of Nuclear Medicine.

Molecular Imaging Pinpoints Inflammation In The Brains Of Schizophrenics And Migraine Sufferers
Source: Headache / Migraine News From Medical News Today [2009.11.02]
Inflammatory response of brain cells - as indicated by a molecular imaging technique - could tell researchers more about why certain neurologic disorders, such as migraine headaches and psychosis in schizophrenic patients, occur and provide insight into how to best treat them, according to two studies published in the November issue of The Journal of Nuclear Medicine.

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Published Studies Related to Prolixin (Fluphenazine)

The effects of olanzapine and fluphenazine on plasma cortisol, prolactin and muscle rigidity in schizophrenic patients: a double blind study. [2007.03.30]
Pharmacotherapy of schizophrenia is associated with the stressful side effects...

A randomized double-blind 12-week study of quetiapine, risperidone or fluphenazine on sexual functioning in people with schizophrenia. [2006.04]
Sexual dysfunction is common in people suffering from schizophrenia and is reported by patients to be a significant reason for medication nonadherence. This report contains data for 27 people with schizophrenia who participated in a randomized double-blind 12-week trial of risperidone (4 mg/day), quetiapine (400 mg/day) or fluphenazine (12.5 mg/day)...

Risperidone, quetiapine, and fluphenazine in the treatment of patients with therapy-refractory schizophrenia. [2005.07]
This 12-week, double-blind study evaluated the effectiveness of risperidone (4 mg/day), quetiapine (400 mg/day), or fluphenazine (12.5 mg/day) in a stringently defined treatment-resistant population of people with schizophrenia. No differences were noted in total Brief Psychiatric Rating Scale (BPRS) or Clinical Global Impression scores among the drug groups (n = 38)...

Thyroid function in treatment-resistant schizophrenia patients treated with quetiapine, risperidone, or fluphenazine. [2005.01]
CONCLUSIONS: It is expected that TT(4) levels will decrease during quetiapine treatment, and this may possibly be related to competitive metabolism of thyroid hormones and quetiapine by UDP-glucuronosyltransferase. Routine monitoring of thyroid function in quetiapine-treated patients without a history of thyroid disease is not recommended.

Chronic treatment with fluphenazine alters parameters of oxidative stress in liver and kidney of rats. [2009.07]
The aim of this study was to assess the toxic effects of chronic exposure to fluphenazine in liver and kidney of rats, as well as the possible protective effect of diphenyl diselenide on the fluphenazine-induced damage. Long-term treatment with fluphenazine caused an increase in lipid peroxidation levels in liver and kidney homogenates.

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Clinical Trials Related to Prolixin (Fluphenazine)

Study of Fluphenazine in Relapsed or Relapsed-and-Refractory Multiple Myeloma [Recruiting]
The purpose of this study is to evaluate the safety and tolerability of fluphenazine in patients with advanced multiple myeloma. The study will also describe the efficacy of this drug.

Fluphenazine Decanoate for Psoriasis [Terminated]
We are doing this research study to evaluate the effectiveness and safety of fluphenazine decanoate when injected with a needle into psoriasis lesions in adults. Fluphenazine decanoate is FDA (U. S. Food and Drug Administration) approved for use in people who have schizophrenia and psychotic symptoms. Fluphenazine decanoate is not approved by the FDA for use in psoriasis. Fluphenazine decanoate slows T cell growth in cells in laboratory test tubes. Its usefulness and safety in people with psoriasis will be investigated in this study.

Fluphenazine Hydrochloride for Psoriasis [Recruiting]
The objective of this study is to assess the safety and biologic activity of intralesional injection of fluphenazine in adult subjects with psoriasis.

Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma [Completed]
RATIONALE: Drugs used in chemotherapy, such as fluphenazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I/II trial is studying the side effects and best dose of fluphenazine and to see how well it works in treating patients with refractory advanced multiple myeloma.

New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment Resistant Schizophrenia [Active, not recruiting]
The purpose of this study is to:

1. Evaluate the efficacy and safety of the new antipsychotics, quetiapine (300-500mg/day) and risperidone (3-4mg/day) compared to each other and to fluphenazine (10-15mg/day), a high potency typical antipsychotic in patients who meet the DSM IV criteria for schizophrenia.

2. To evaluate the efficacy and safety of quetiapine (1200mg/day) in patients who have not responded to conventional and newer antipsychotics.

3. To evaluate the effectiveness of quetiapine (300-500mg/day), and risperidone (3-5mg/day) compared to each other and fluphenazine (10-15mg/day) in the treatment of hostility and aggression in treatment-resistant schizophrenic patients.

4. To evaluate the effectiveness of quetiapine (300-500mg/day) and risperidone (3-5mg/day) compared to each other and fluphenazine (10-15mg/day) on rates of discharge, quality of life, and independent living skills.

5. To assess prolactin levels and to evaluate any relationship with sexual dysfunction and menstrual irregularities.

6. To evaluate the possible differential impact of treatment conditions on cognitive functioning including measures of attention, motor speed, problem solving, verbal and visual memory, and verbal processing speed.

7. To measure changes in weight and health consequences associated with weight changes.

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