Glaxo looks like it’s moving on from Seroxat – there’s not really any money left in that drug now it’s out of patent… so let’s all say a big hello to Gepirone ER – the first-in-class 5HT1a agonist.
The press release (below) still seems keen to ‘suggest’ a link between Serotonin and depression – but today, we all know that’s rubbish – see here and here. What the press release does not do is to tell us exactly HOW Glaxo thinks Gepirone ER might treat depression… but it does affect brain serotonin by binding to serotonin 5HT1a receptors. That’s OK then – I’m sure that’s all the FDA and the MHRA will need to know.
One more point, the press release mentions, and I quote “…for the treatment of MDD, an illness for which there is still a great unmet need despite the availability of treatment options.” WHAT? So we’ll forget the tens of millions of prescriptions that have already been written for the ‘wonder drugs’ that were SSRIs such as Seroxat and Prozac. Forget all those – there’s still “a great unmet need” for MDD treatment.
How do I know? Glaxo told me:
LONDON, HOUSTON, 8th February 2007-GlaxoSmithKline (GSK) and Fabre-Kramer Pharmaceuticals, Inc. (FKP) today announced an exclusive worldwide agreement for gepirone ER, a 5HT1a agonist expected to be submitted in this quarter for Food and Drug Administration (FDA) review in the US for major depressive disorder (MDD). The agreement includes development and commercialisation of gepirone ER as well as development opportunities for follow-on products.
Subject to approval, gepirone ER will be the first-in-class 5HT1a agonist indicated for the treatment of MDD, an illness for which there is still a great unmet need despite the availability of treatment options. Gepirone ER affects brain serotonin by binding to serotonin 5HT1a receptors. Clinical study data suggest that gepirone ER treats depression with a low risk for sexual side effects that are known to occur with current therapies that work via serotonergic mechanisms. These side effects often lead patients to discontinue therapy. In clinical trials, dizziness/lightheadedness and nausea were the most frequently reported adverse events and occurred most often during early stages of treatment. Discontinuations due to these adverse events were less than 5%.
Stephen J. Kramer, M.D., CEO of FKP, commented, “We are excited about this alliance because we are confident that GSK, through its outstanding experience in the depression market will, once approved, successfully commercialise and further develop gepirone ER to help the many depressed patients for whom existing therapies are simply not satisfactory.”