April 06, 2007

New Medication in Testing for Schizophrenia Has Good Metabolic Safety Profile

Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. have reported on late-stage clinical trial safety data for its investigational medication for schizophrenia, bifeprunox.

The companies say their clinical data indicates that the use of bifeprunox may have less risk of the factors associated with metabolic syndrome than other drugs currently being used to treat schizophrenia. Risk factors associated with metabolic syndrome are weight gain (especially in the abdominal area), glucose (blood sugar) dysregulation, and elevated lipids (cholesterol and triglycerides). The manufacturer's press release says that weight gain and lipid changes from bifeprunox were similar to placebo.

As with all medications - people should keep in mind that with new medications it takes a number of years for the negative side effects to be discovered so it will take quite a while before the true strengths and weaknesses of any drug are known.

According to an article on Medscape, a key researcher, Dr. Herbert Y. Meltzer, says that results showed that bifeprunox has a good safety profile in the areas of extrapyramidal symptoms, prolactin levels, weight gain, and measures of lipids (which is a marker for cardiovascular risk), and glucose dysregulation (which is a marker for prediabetes).

Here is an excerpt from Wyeth and Solvay's press release:

Metabolic and Safety Parameters of Bifeprunox

  • In analyses of data from Phase 3, six-week, randomized, double-blind, placebo-controlled active-referenced studies:
    • Bifeprunox had favorable effects on total cholesterol, triglycerides (TG), very low-density lipoprotein and low-density lipoprotein, similar to placebo. 
    • Bifeprunox patients experienced decreases in body weight, body mass index (BMI) and prolactin and had an extrapyramidal side effects profile similar to placebo.
  • Weight, BMI and lipids were assessed in patients with acute exacerbations of schizophrenia in an analysis of another Phase 3, six-week, randomized, double-blind, placebo-controlled active-referenced study:
    • Weight decreases and minor reductions in BMI were observed in patients who received bifeprunox. 
    • Cholesterol and TG levels improved in patients who received bifeprunox.

Read the Full Article: Schizophrenia Drug Has Favorable Metabolic Safety Profile (Free Registration Required)

Link to the full press release: Safety Analyses of Clinical Data for Bifeprunox in Patients with Schizophrenia Showed a Favorable Weight and Lipid Profile, Similar to Placebo

Related Reading: Solvay Seeks Approval From FDA on New Schizophrenia Drug


Is Bifeprunox on the market today and does it have good results controlling the symptoms of schizo and schizoaffective disorders? I hear that clozaril is the last hope drug but causes in 1% of the people taking it the lowering of white blood cell counts, which is dangerous and needs to be monitored every week with blood tests.

Posted by: Mari Cook at April 8, 2007 03:04 AM

This medication is still undergoing clinical trials and is not yet FDA approved. It looks promising with good symptom control and few side-effects, .... BUT ... many drugs early on look good, and the real story can take years to emerge by real-life usage.

Posted by: Jeanie at April 8, 2007 02:32 PM

The drug companies are notoriously known for spinning and marketing their drugs in a positive direction. It’s a press release from the drug company. What else are they going to say? This drug may cause sudden death, obesity, cardiac arrest, and diabetes? The real story will be told when real people start taking the drug.


Posted by: Yaya at April 8, 2007 09:19 PM

Yaya you are correct. But what is better yarn than HIDING THE EFFICAY of drug CLOZAPINE by highlighting the sideffect agranulocystosis while this sideffect may be common to other anti psychotics as well like respirodone,quetepine, olanzapine etc
As the clamour for INTIAL PRESCRIPTION FOR CLOZAPINE IN LOWEER DOSAGE IS COMING INTO FORE BY HONEST psychiatrists, the MNCs are coming out with new drugs which follows the unique route of clozpine.
As a carer who has used sernace, haeperidol,orap,trinicalm plus, forte, flunaxol,fourexetine etc etc, i can vouch for CLOZAPINE IN LOWER DOSAGE IN THE FIRST INSTANCE ITSELF IS THE CORRECT METHOD OF TREATING MENTALILLNESS.

Posted by: captainjohann at April 8, 2007 10:51 PM

we wanted to know about Amazeo-100 medicine and its side effect

Posted by: srishti dunkal at April 27, 2007 08:55 AM

What side effect amezeo 200 have ?

Posted by: Rajesh Bansode at July 6, 2007 08:12 AM

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