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November 13, 2007What Impact Will the FDA’s Rejection of GlaxoSmithKline’s Gepirone ER Have for Other Experimental Serotonin 5-HT1a Partial Agonists in Depression?
Analysis of: U.S. rejects Glaxo’s gepirone ER antidepressant | biz.yahoo.com
Author: Louis Sanfilippo, President, LCS Group, LLC
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...
November 12, 2007Is Potential Taisho-Pfizer Alliance on mGluR Schizophrenia Drug Candidate Coming Too Late?
Analysis of: Taisho and Pfizer Sign a Letter of Intent for Taisho's Schizophrenia Drug Candidate | biz.yahoo.com
Author: Louis Sanfilippo, President, LCS Group, LLC
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,...
October 24, 2007Just How Effective Will Orexigen’s Contrave Be As An Obesity Treatment
Analysis of: OREXIGEN(TM) Therapeutics Initiates its Third Phase III Trial for Contrave(TM) to Treat Obesity | biz.yahoo.com
Author: Louis Sanfilippo, President, LCS Group, LLC
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...
October 23, 2007Clinical Data’s Vilazodone Hits Mark on Phase III Depression Trial
Analysis of: Clinical Data Announces Positive Results from Phase III Pivotal Trial of Vilazodone for Depression | www.pipelinereview.com
Author: Louis Sanfilippo, President, LCS Group, LLC
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...
October 22, 2007Interpreting Preliminary Phase II-B Results for Forest Labs and Gedeon Richter’s RGH-188 in Schizophrenia Treatment
Analysis of: Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia | www.pipelinereview.com:80
Author: Louis Sanfilippo, President, LCS Group, LLC
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...
October 16, 2007Lundbeck’s “Serotonin Modulator and Stimulator” Lu AA21004: How Novel? How Good?
Analysis of: Lu AA21004 shows highly significant results in clinical phase II trial | www.pipelinereview.com
Author: Louis Sanfilippo, President, LCS Group, LLC
Lundbeck’s lead antidepressant in development, Lu AA21004, reportedly achieved ‘highly significant’ results on primary endpoints in a recent Phase II major depression clinical trial. This is definitely good news for Lundbeck and partner Takeda which hope to have Lu AA21004 on the market by 2011, just...
October 12, 2007CX717: Cortex Pharmaceutical’s Ampakine Drug for ADHD Struck Down by FDA
Analysis of: FDA's Psychiatric Division has Rejected Cortex’s Request to Study CX717 in Phase IIb ADHD Study | www.pipelinereview.com
Author: Louis Sanfilippo, President, LCS Group, LLC
The FDA’s decision to not approve the investigational new drug application for CX717 (Cortex Pharmaceuticals) in the treatment of ADHD is bad news for the class of molecules known as ampakines and certainly for Cortex, which has experienced a handful of setbacks over the years. Ampakines have recently...
October 11, 2007
Vanda"s Iloperidone: Lemonade or Lemon
Analysis of: Vanda Pharmaceuticals Submits Iloperidone New Drug Application | www.pipelinereview.com
Author: Lawrence Ginsberg, President, Red Oak Psychiatry Associates, P. A.
Vanda"s Iloperidone: Lemonade or Lemon
Analysis of: Vanda Pharmaceuticals Submits Iloperidone New Drug Application | www.pipelinereview.com
Author: Lawrence Ginsberg, President, Red Oak Psychiatry Associates, P. A.
1. Iloperidone has demonstrated efficacy in treating positive and negative symptoms of schizophrenia and also has a favorable safety profile. 2. Vanda has utilized pharmacogenetic studies to identify a group of schizophrenic patients that will benefit from this agent that binds to a number of serotonin...
October 8, 2007
DOV 21,947: A Triple Reuptake Inhibitor With a Favorable Metabolic Profile
Analysis of: DOV 21,947 Demonstrates Significant Body Weight and BMI Reductions in Drug Compliant Subjects in Phase Ib Clinical Study | www.medicalnewstoday.com
Author: Lawrence Ginsberg, President, Red Oak Psychiatry Associates, P. A.
DOV 21,947: A Triple Reuptake Inhibitor With a Favorable Metabolic Profile
Analysis of: DOV 21,947 Demonstrates Significant Body Weight and BMI Reductions in Drug Compliant Subjects in Phase Ib Clinical Study | www.medicalnewstoday.com
Author: Lawrence Ginsberg, President, Red Oak Psychiatry Associates, P. A.
1. DOV 21,947 in a phase Ib study produced a statistically significant reduction in plasma triglyceride levels, body weight, and Body Mass Index (BMI). 2. This compound is believed to not only manage depression but also impact weight gain. 3. A phase II study of DOV 21,947 is being delayed until the...
October 5, 2007Treating Adolescent Depression
Analysis of: Dual Approach Aids Depression Treatment | online.wsj.com
Author: Louis Sanfilippo, President, LCS Group, LLC
The study reflects growing attention to the evaluation and treatment of adolescent major depression. Untreated, the consequences can be devastating, potentially lifelong, and even fatal. While this can be the case with depression in general, adolescence is a vital period developmentally and untreated...
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