GLG News by Physicians who Treat Insomnia (US)

Pfizer has tentatively agreed to partner with Taisho to develop and commercialize the new schizophrenia drug TS-032 outside Japan.  This move may support Pfizer’s efforts to expand its share in the antipsychotic market beyond Geodon.

FDA has recently approved once-daily Seroquel XR for maintenance treatment of adult schizophrenia patients.  Risk of relapse and recurrence of acute psychotic symptoms were 84% less in patients receiving Seroquel XR vs. placebo.

It is a good idea to have FDA approval for disorders in children because this aspect of the pharmacopea is not well developed.  Aripiprazole is an atypical "atypical" neuroleptic that will likely have some beneficial effects in behavioral dyscontrol, but is not likely specific to bipolar I disorder. ...

GlaxoSmithKline’s Gepirone ER, a serotonin 5-HT1a partial agonist licensed from Fabre-Kramer Pharmaceuticals, was issued a non-approvable letter following an amended NDA submission to the FDA this past spring. This isn’t all that surprising given gepirone’s history, including a similar non-approvable...

Investigational drug candidates that target metabotropic glutamate receptors (mGluR) show promise as novel treatments for a range of CNS disorders which include schizophrenia, anxiety, chronic pain, Huntington’s Disease, epilepsy and Parkinson’s Disease. If Pfizer consummates this deal with Taisho,...

Pfizers failure on Exubera were not of safety issues, or complicated device, or even consumer marketing problems.  Their biggest issue that brought failure was the lack of payer coverage.  Almost no payer in the US added Exubera to their formulary or saw any value over injectable insulin...

Obesity is a major health issue with significant associated morbidity and with rates only rising, especially among the young. OREXIGEN Therapeutics’ Contrave is moving along as a potential treatment of obesity, having initiated its third Phase III trial. Contrave is a novel combination-drug concept...

It is fundamentally a good idea to focus on central nervous system interventions for over-eating, as opposed to metabolic regulation of glucose catabolism in the periphery.  It is also very economical ("sound business") to use agents that are not patent-protected to try this really good idea. ...

Clinical Data’s antidepressant Vilazodone, a mixed selective serotonin reuptake inhibitor (SSRI) and serotonin 5-HT1a partial agonist, met both primary and secondary endpoints for the treatment of major depression in a pivotal phase III trial. Combining SSRIs and 5-HT1a partial agonists as separate...

RGH-188, a dopamine D2/D3 antagonist, is a potential treatment for schizophrenia and bipolar mania developed jointly by Forest Laboratories, Inc. and Gedeon Richter. Reported top-line results of this 389 patient randomized, placebo-controlled, Phase IIb trial for RGH-188 in schizophrenia show ‘nominally...