Gepirone ER – enter Marty Keller

You may remember I wrote about Gepirone ER a while ago. It’s a drug that has been around for a while and in fact it “was determined by the FDA in June 2004 as not approvable” when Organon tried to get a licence for it. Strange how the information below – from the Fabre Kramer website fails to mention the fact it was not approvable in 2004…

Gepirone ER
Therapeutic Area(s): Major Depression
Phase of Development: NDA under review at FDA

Development Status:
NDA Amendment planned for 2007

Product Description
Gepirone extended release (ER) is a 5HT1A partial agonist. Antidepressant effects are believed to be due to an agonist effect on post synaptic serotonin receptors. Gepirone is the first in this class of direct serotonin agonists.

The extended release formulation of Gepirone allows once daily dosing with a favorable side effect profile. Gepirone ER is the first successful extended release formulation of a 5HT1A partial agonist.

Clinical Trials
An NDA was submitted in May 2001. The FDA stated that there was one immediate release Gepirone trial in major depression that was positive and one extended release study that was positive. The FDA requested one further short term efficacy trial. There were no serious outstanding issues on CMC or preclinical data.

Fabre-Kramer initiated two 8 week trials of Gepirone extended release in the treatment of major depression. The results of these trials were positive and will form the basis of the amendment to the FDA.

The accumulated safety data for Gepirone is huge. There have been 850 subjects entered in Phase I trials. In Phase II & III, 1900 patients have been treated with Gepirone Immediate Release and 3100 with Gepirone Extended Release. In addition, 634 children and adolescents were enrolled into pediatric trials in depression.

The extensive clinical experience with Gepirone has shown it free of troublesome adverse events. Common adverse events are limited to transient lightheadedness, nausea, and headache. Sexual dysfunction and weight gain, common problems with other antidepressants, are not found with treatment of Gepirone ER.

Partners
Worldwide commercialization rights licensed to GlaxoSmithKline.

Perhaps you might also remember that Glaxo had bought the rights to the failed drug and Stephen J. Kramer, M.D., CEO of Fabre Kramer said “We are excited about this alliance [with Glaxo] because we are confident that GSK, through its outstanding experience in the depression market will, once approved, successfully commercialise and further develop gepirone ER….”

Clearly in order to get the drug approved by the FDA, Glaxo’s “outstanding experience” decreed there would have to be new clinical trials… and hey presto – enter Marty Keller and his Gepirone ER trials! Who better to ‘prove’ Gepirone ER was actually a fantastic, very safe new drug than the famous Marty Keller of Seroxat study 329 fame.

Glaxo can always rely on Marty to step up and bat for them – you can watch him in action here in the recent Panorama programme, Secrets of the drug trials.

Yep, when the going gets tough, Marty Keller is your man – the cynics amongst you might think he’ll say whatever Big Pharma want him to as long as the price is right.

Back on February 13 I wrote: Glaxo really doesn’t want to let go of trying to connect Serotonin with a cure for depression – even if, in the case of Gepirone ER, they are more than a bit wooly about the truth – “Gepirone ER affects brain serotonin by binding to serotonin 5HT1a receptors.”

Is this a good thing? Who knows, but at least the PR company has got ‘Gepirone ER’ in the same sentence as ’serotonin’. That’s got to be a start, I suppose – perhaps marketing can build on this sentence with a scientific paper from ‘Marty’ Keller to ‘prove’ it is a good thing!

I was a little slow – seems someone had already got Marty on the case….

5 Responses to “Gepirone ER – enter Marty Keller”

  1. BOB FIDDAMAN Says:

    Keller should be arrested and charged NOW!

    His bank balance reeks of death and misery

    Fid

  2. truthman30 Says:

    http://truthman30.wordpress.com/2007/04/14/seroxat-link-6-scamming-seroxat-the-players/

    Marty Keller…( check out the link above )
    An interesting “player” in the Seroxat Scam…

  3. seroxat secrets… Top posts for May « Says:

    […] Gepirone ER – enter Marty Keller […]

  4. truthman30 Says:

    I think people have to realize the way psychiatrists such as Martin Keller actually view those they have diagnosed with a “psychiatric disorder” such as depression or anxiety etc.

    Once a psych has diagnosed you with one otheir pseuo-fraud labels , they have effectively snared you into their regime and with this , you are no longer granted the same weight of opinion or thought as those not diagnosed with a psych-disease. It becomes somewhat of a doctor-guinea pig relationship and the psychiatrists main aim is to get you on any psychiatric drug no matter what the original diagnosis is. Their intention is to “drug you for life” , disable your emotions, and totally disempower you as an individual.
    Psychiatrists who are in the pockets of drug companies are the worst kind of medical practicioner, for they do not realize the ful extent of the evil forces of which they serve.

    Psychiatrists who front drug company propaganda are just as expendable as the patients who are targetted with Psych drugs. This is a fact that their super-size egos have yet to realize though.

    The way the pharmaceutical companies operate is similar to the way any Major illegal drug baron would operate. They are like the Big Coke Baron sitting in his palace in Columbia, untouchable and well protected. The pharmaceutical reps are like the drug mules… They carry the poisons into GP surgeries and pychiatric hospitals , “try this high grade heroin , try this pure cocaine , try this new SSRI…. ”

    The doctors who prescribe and promote this crap are like the petty criminals who peddle street drugs on street corners and back alleys of every town and city across the world. The only difference being, some are Big time dealers and some are small time. The highest precribers are rewarded by the pharmaceutical companies, and thus they make more money…They become local dealers… But with that they sell their soul, their conscience and their reputation…

    So when this shit hits the fan, and some dodgy E tabs begin to make some users sick or some heroin cut with washing powder begins to kill the junkies on the street, its the local and small time dealers who end up being the ones to blame, not the Drug lord in his Fortress in South America
    The GPs and psychs are on the front line prescribing these poisons, choosing their targets, they are the ones who serve pharma , with their “all expenses paid trips” and seminars they don’t seem to realize that all they are is a small pawn in a Big Game, and they are just as expendable and irrelavant as the “statistical” dead patients in the end…

  5. Chris Says:

    Unrelated to big pharma workings, but I was in a trial for this drug and did find it helpful with anxiety. I’d like to see it studied for that rather than “major depression”.


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