July 04, 2007

Bifeprunox: New Schizophrenia Medication Phase III Study Results

In May of 2007, pharmaceutical companies Wyeth, Solvay and psychiatric research company Lundbeck reported more recent findings on bifeprunox, a possible new drug for treating schizophrenia that has been in the works for some time now. New research including 6-months of data looked at stabilized adults with schizophrenia using a randomized, double-blind, placebo-controlled phase III study. (basic drug study information). Of course, with all new medications - many side effects don't become well known until many years after launch, so its impossible to say for sure what additional side effects may be caused by a new medication.

Bifepronox news has been covered on this site before, and was seen as a possible new advancement in the medication treatments of schizophrenia. In 2006, phase III trails were delayed and not expected till 2008; but in a positive turn, the first 6-months of data are available now. In 2004, Schizophrenia Bulletin had these hopeful things to say about bifeprunox:

Bifeprunox, is a novel third-generation antipsychotic that exhibits partial agonist properties for dopamine D2 as well as serotonin 5-HT1A receptors. Bifeprunox, which was developed by Solvay, has shown efficacy superior to haloperidol in Phase III clinical trials, with few side effects. The drug is effective on both positive and negative symptoms and appears to present little risk for weight-gain, cardiovascular, or extrapyramidal side effects.

In analyses of data from one Phase 3, six-month, randomized, double-blind, placebo-controlled study:

• Compared with placebo, bifeprunox significantly prolonged time to deterioration over six months.
• Bifeprunox patients experienced decreases in body weight and body mass index vs. placebo over six months.
• Bifeprunox patients showed favorable effects on total cholesterol, triglycerides, very low-density lipoprotein and low-density lipoprotein, comparable with placebo over a six-month period.
• In these analyses, the most common side effects reported with bifeprunox (incidence of greater than or equal to 5 percent and twice the placebo rate) included nausea, vomiting, dizziness, anorexia, akathisia, dyskinesia and asthenia.

"We are encouraged by these additional analyses of clinical data, which underscore bifeprunox's favorable weight and lipid profile," says Earl Sands, M.D., Vice President, Research and Development at Solvay Pharmaceuticals, Inc. "Bifeprunox, if approved, may be an important treatment option in the long-term management of adult patients with schizophrenia."


appears to present little risk for weight-gain, cardiovascular, or extrapyramidal side effects.

Sounds good to me , i wonder how many years it will take to filter down to the average user.

Posted by: Salty Davis at July 4, 2007 01:32 PM

This and another new drug known so far as ACP-104 are so close to being ready and superior by the sounds of it. neuropsychiarty now takes biology into account and I do hope these will not take too much longer.Have a look a Ness-Foundation ,there's some facinating things happening there too.

Posted by: Margaret Pain at July 6, 2007 01:50 PM

Can someone help me determine whether this medicine my son is on has his tongue
twisting and hanging out his mouth. He's gained weight also, I do hope some medicine can be helpful.

Posted by: cheryl white at July 6, 2007 04:49 PM

Reactions such as this could be a side-effect and should be reported to the doctor right away. The doctor may wish to add something to alleviate side-effects, change the dosage of the current medication, and/or change the medication. Please let the doctor know.

Posted by: Jeanie at July 7, 2007 06:24 AM

Is this trial being carried out by using placebo or against the BEST medication available now which is clozapine? this seems to be one of those new gimmicks by drug MNCs who fool the public with their goodies by talking about side effects. What is the effect on POSITIVE AND NEGATIVE SYMPTOMS COMPARED TO CLOZAPINE?

Posted by: captainjohann at July 11, 2007 07:02 PM

I would like to know re: the
approx. launching time of this bifeprunox and like some others I am also curious
to know the genuine effect of this med on the NEGATIVE
symptoms. The positive symptoms of sz are often well treated by many other med but so far all antipsychotics have had very little effect on the negative
symptoms except probably clozapine with a very high price to pay with severe weight gain and other awful side effects. If bifeprunox is ever launched and its metabolic issues are nil and no weight gain etc as they claim THEN it would be a WONDER DRUG to so many sufferers and the families. I
and look forward to its availability worldwide.

Posted by: jena at July 16, 2007 01:16 PM

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