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…
Therapeutic Area(s): Major Depression
Phase of Development: NDA under review at FDA
NDA Amendment planned for 2007
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.
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.
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….