GLG News by Clozaril Prescribers (US)

Direct comparisons between potential competing agents often do not exist Initial FDA approval is usually based on comparisons to placebo A new approval does necessarily mean that the new agent is better than existing ones, although this is implied by industry Industry bears all the costs of efficacy...

All currently marketed antipsychotic medications for treating  schizophrenia  rely on mechanisms of action  which target  dopamine and  serotonin receptors.  Although these medications reduce delusions and hallucinations without inducing symptoms of Parkinson's Disease...

The clinical trial which was done has shown only comparable efficacy to available treatment for positive symptoms.  It did not study efficacy for cognition or negative symptoms.  It did not test efficacy in treatment resistant patients. It did not show long term efficacy. It did not show that...

Pfizer Inc (NYSE:PFE) and Taisho Pharmaceutical Co., Ltd. (OTC:TSOPF.PK) announced the signing of a definitive agreement for worldwide collaboration to research, develop and commercialize TS-032.   TS-032 is a metabotropic glutamate receptor (mGluR) agonist, a novel drug candidate for the...

Addex Pharmaceuticals (Swiss:ADXN.SW) announced on January 3, 2008 an exclusive worldwide license agreement with Merck & Co., Inc. (NYSE:MRK) to develop ADX63365, a potent and selective positive allosteric modulator of the metabotropic glutamate receptor subtype 5 (mGluR5) with potential for the...

1. The results of this study demonstrtae a treatment in development, PRX-03140, which may provide stronger pro-cognitive effects than those currently available for Alzheimer's disease. 2. PRX-03140 may be a disease altering alternative to other treatments currently in development. 3. The mechanism...

On November 26 Schering-Plough Corporation (NYSE: SGP) announced the acceptance of the New Drug Application (NDA) for asenapine by the U.S. Food and Drug Administration (FDA). Schering-Plough is seeking marketing approval from the FDA for the treatment of schizophrenia and acute mania or mixed episodes...

Forest Laboratories, Inc (NYSE:FRX) and Gedeon Richter announced preliminary top line results from a Phase II-B ranomized, double-blind placebo-controlled, 6 week study of RGH-188 for the acute treatment of schizophrenia in 389 patients. These results have prompted the companies to announce their intentions...

The announcement of Eli Lilly’s (NYS:LLY) successful proof of concept study with LY2140023 in patients with schizophrenia represents a new milestone in the pharmacological treatment of schizophrenia and related psychotic disorders. Not since the introduction of thorazine or risperidone have we witnessed...

My clinical experience with Tenex (guanfacine) was that it was most effective as an add-on treatment for ADHD with associated aggressive behavior. I expect that Intuniv will have the same efficacy limitations. Nonetheless, Intuniv's ease of use and tolerability along with FDA approval should...