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GLG News by Psychiatrists (US)

Analysis of: Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA (www.pipelinereview.com)
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...
Analysis of: Forest Laboratories and Lundbeck announces positive results of Lexapro(R) phase III study in adolescents with major depression (www.pipelinereview.com)
If this study leads to FDA approval of Lexapro for use in adolescents it should lead to an increase in its use overall, by psychiatrists and by primary care physicians, including pediatricians.
Analysis of: Study Shows Weight-Loss Drug Rimonabant is Associated with Severe Adverse Psychiatric Events (pharmalive.com)
We have been hoping that remonibant, the cannabinoid antagonist, would allow patients with obesity to lose weight "pharmacologically" without actually having to undergo the significant effort to reverse a lifetime of self-destructive behaviors that have culminated in pathological obesity--obesity that...
Analysis of: Abilify(R) (Aripiprazole) Supplemental New Drug Application For Bipolar I Disorder Pediatric Patients Accepted For Priority Review By FDA (www.medicalnewstoday.com)
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. ...
Analysis of: Seroquel XR Receives Approval From FDA for Maintenance Treatment of Schizophrenia (pharmalive.com)
Because the studies did not compare Seroquel XR to Seroquel, the true impact of the approval of the XR formulation is unclear.
Louis Sanfilippo, MD, President
Louis Sanfilippo, MD, President
LCS Group, LLC
Analysis of: U.S. rejects Glaxo’s gepirone ER antidepressant (biz.yahoo.com)
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...
Louis Sanfilippo, MD, President
Louis Sanfilippo, MD, President
LCS Group, LLC
Analysis of: Taisho and Pfizer Sign a Letter of Intent for Taisho's Schizophrenia Drug Candidate (biz.yahoo.com)
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,...
Louis Sanfilippo, MD, President
Louis Sanfilippo, MD, President
LCS Group, LLC
Analysis of: OREXIGEN(TM) Therapeutics Initiates its Third Phase III Trial for Contrave(TM) to Treat Obesity (biz.yahoo.com)
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...
Analysis of: OREXIGEN(TM) Therapeutics Initiates its Third Phase III Trial for Contrave(TM) to Treat Obesity (biz.yahoo.com)
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. ...
Louis Sanfilippo, MD, President
Louis Sanfilippo, MD, President
LCS Group, LLC
Analysis of: Clinical Data Announces Positive Results from Phase III Pivotal Trial of Vilazodone for Depression (www.pipelinereview.com)
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...

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