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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 7 of 7. This is the beginning of the thread.
Posted by Jameswarnica on July 1, 2005, at 17:35:02
It looks like Fabre-Kramer acquired Gepirone. See http://www.mysan.de/article128649.html
And now Fabre-Kramer issued this press release.
Fabre-Kramer Announces Positive Phase III Results for Gepirone ER in Major Depression Program
Wednesday June 29, 8:30 am ET
HOUSTON, June 29 /PRNewswire/ -- Fabre-Kramer Pharmaceuticals, Inc. announced today the results of its Phase III program for Gepirone ER in Major Depression. Two double-blind, multi-center, randomized, placebo-controlled clinical studies were conducted in moderately depressed patients. One study, FKGBE007, conducted in 248 depressed patients, met the pre-specified endpoint with patients treated with Gepirone ER showing reduced symptoms of depression compared with placebo judged by the physician rated Hamilton Depression Scale, p=0.032. The results for the secondary endpoints were also statistically significant. The second study, FKGBE008, conducted in 206 depressed patients also showed improvement in depressive symptoms by week 2 and throughout the study, but failed to reach statistical significance at endpoint. In both studies, the responder rate (patients having a 50% decrease in depressive symptoms) was statistically significant for Gepirone ER compared to placebo. While the first study yielded statistically significant results for Gepirone ER, the second is considered supportive.
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The results of these two studies augment earlier positive studies conducted on the drug for major depression and enable Fabre-Kramer to submit an improved set of data to the FDA for review. Later this year, Fabre-Kramer plans to submit an amended NDA to the FDA. Stephen J. Kramer, M.D., CEO, stated, "Gepirone ER represents the first of a new class of antidepressants, the direct serotonin agonists. Working by a new mechanism of action, Gepirone ER, if approved, could provide a new treatment modality for depressed patients who are not helped by currently available treatments."The majority of adverse events attributable to Gepirone ER treatment in both studies were lightheadedness and nausea, common antidepressant side effects. Accommodation to these adverse events occurred with continued Gepirone ER treatment. Other side effects usual with antidepressant treatment, such as sexual dysfunction, were not seen in Gepirone ER treated patients in either study.
If approved for commercialization by FDA, Fabre-Kramer expects Gepirone ER to compete favorably in the $20 billion world-wide antidepressant market.
About Fabre-Kramer
Fabre-Kramer Pharmaceuticals, headquartered in Houston, Texas is engaged in acquiring, developing and commercializing psychotropic drugs that have significant market potential. In addition to Gepirone ER, Fabre-Kramer has 10 other compounds in various stages of development for indications including depression, anxiety, schizophrenia, Parkinson's disease and insomnia.
Posted by linkadge on July 1, 2005, at 17:41:39
In reply to Gepirone Positive Studies, posted by Jameswarnica on July 1, 2005, at 17:35:02
Posted by Jameswarnica on July 1, 2005, at 17:53:45
In reply to I WANT THIS MED TO COME OUT!! (nm), posted by linkadge on July 1, 2005, at 17:41:39
I agree. Especially since it doesn't have some of the side effects of the SSRIs. I hope the FDA moves quickly on this one. They've been approving almost the same type of depression medicine for awhile now--the SSRIs. At least this will be something new--finally.
Posted by linkadge on July 1, 2005, at 19:22:11
In reply to Re: I WANT THIS MED TO COME OUT!!, posted by Jameswarnica on July 1, 2005, at 17:53:45
thats exaclty it. I think it would offer >=modest effects with very little drawbacks. Plus gepirone is more active in the frontal cortex then buspar is.
Linkadge
Posted by SLS on July 2, 2005, at 7:02:55
In reply to Re: I WANT THIS MED TO COME OUT!!, posted by linkadge on July 1, 2005, at 19:22:11
It's too bad that drug companies don't support studies of compounds to be used as adjuncts to antidepressants in depression as they do in epilepsy. Lamictal, Neurontin, Topiramate, etc. were studied and approved by the FDA as adjuncts to other AEDs and not as monotherapy. Gepirone might serve better as an adjunct to ADs rather than as monotherapy.
- Scott
Posted by Jameswarnica on July 7, 2005, at 18:51:09
In reply to Re: I WANT THIS MED TO COME OUT!!, posted by SLS on July 2, 2005, at 7:02:55
> It's too bad that drug companies don't support studies of compounds to be used as adjuncts to antidepressants in depression as they do in epilepsy. Lamictal, Neurontin, Topiramate, etc. were studied and approved by the FDA as adjuncts to other AEDs and not as monotherapy. Gepirone might serve better as an adjunct to ADs rather than as monotherapy.
>
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> - Scott
>
> Actually, based on these two studies, I would say that Gepirone is better as its own monotherapy. They ran two studies and one was statistically significant and the other supportive. I have heard that for the SSRIs, only 1 out of 3 studies usually shows statistically significant results. Here you have 1.5 out of 2. That's impressive. Also, since one of the big positives of gepirone is the lack of side effects seen in the SSRIs, taking gepirone with an SSRI would negate this.
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Posted by Francis on July 8, 2005, at 18:19:33
In reply to Gepirone Positive Studies, posted by Jameswarnica on July 1, 2005, at 17:35:02
I agree with James. Gepirone is not an adjunct therapy--it's a monotherapy. I've been following this medicine for some time and these studies only further support my impressions of gepirone, especially when compared to the SSRIs.
First, the studies show that Gepirone does not cause or worsen sexual dysfuntion. On the otherhand, the literature shows that between 39% and 70% of patients on SSRIs suffer increased sexual dysfunction problems. What makes this ironic is that many depressed patients, as either a cause or effect of the depression, suffer from sexual dysfunction. This is also one of the reasons patients have stopped taking SSRIs--and, then the depression relapses.
Second, patients on Gepirone appear to have a decrease in anxiety-even during the first two weeks. On the otherhand, SSRIs appear to cause an increased anxiety during the first two weeks--I'm curious if this is one of the reasons that people have problems with the SSRIs early in their treatment.
Third, patients on Gepirone show improvement after just two weeks according to the latest studies. SSRIs, I believe, generally take up to 4 weeks.
These are just a few of the reasons I see Gepirone as a monotherapy. Hopefully this medicine will come to market.
This is the end of the thread.
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