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GLG News by SSRI Prescribers (US)

Analysis of: Arana Announces Phase II Trials For Lead Compound ART621 (www.peptech.com)
Helping regenerate or preventing death of dopaminergic neurons in the motor system is novel and exciting.  That is the strategy described in the accomapanying clinical trial of insertion of a nerve growth factor gene into the putamen of patients with Parkinson’s disease—a region of the brain affected...
Analysis of: New Phase 3 Data Showed PRISTIQ Significantly Reduced Symptoms of Major Depressive Disorder Versus Placebo (www.pipelinereview.com)
Here we go again; look at all metabolites of a successful drug for efficacy to increase your bang for the corporate buck.  Brilliant--because success is virtually assured at relatively little cost.  Venlafaxine is a reasonably good antidepressant, and in my experience, useful except in...
Analysis of: Forest Laboratories and Lundbeck announces positive results of Lexapro(R) phase III study in adolescents with major depression (www.pipelinereview.com)
At this stage there is a paucity of antidepressants that are approved in adolescent depression, even though antidepressants were perhaps excessively used until the recent concern over their increasing suicide risk.  So it is a very good strategy to extend patent somewhat by cornering the adolescent...
Analysis of: Forest Laboratories and Lundbeck announces positive results of Lexapro(R) phase III study in adolescents with major depression (www.pipelinereview.com)
The push for FDA approval of Lexapro into the adolescent depression market could significantly impact sales of this already successful medication.
Analysis of: FDA and Drug Marketing - Plan toTell Doctors of Off-Label Uses (online.wsj.com)
An FDA draft proposal regarding off-label drug promotion, if approved and implemented, could be a boon to both pharmaceutical companies and physicians...and ultimately to patients as well.
Analysis of: New Phase 3 Data Showed PRISTIQ Significantly Reduced Symptoms of Major Depressive Disorder Versus Placebo (www.pipelinereview.com)
PRISTIQ, the single isomer form of Effexor, has performed well in a Phase III study, done in response to an FDA approvable letter earlier this year.  When launched it will change the balance of antidepressants prescribed for major depressive disorder.  
Analysis of: Gene A/S begins Phase Ib clinical trial with NsG0202 for the treatment of Alzheimer's disease (www.pipelinereview.com)
Nerve growth factor has some connection to Alzheimer's but the mechanism is not clear.  In Alzheimer's, nerve growth factor is actually increased in the brain, EXCEPT, in the nucleus basalis, and this may be crucial.  Will this delivery system get it there?  And then, will it work?
Analysis of: New Phase 3 Data Showed PRISTIQ Significantly Reduced Symptoms of Major Depressive Disorder Versus Placebo (www.pipelinereview.com)
The announcement of positive results for PRISTIQ (desvenlafaxine succinate) for the treatment of Major Depression is good news for Wyeth.  PRISTIQ takes over where EFFEXOR left off in the Wyeth CNS portfolio.  Studies for the treatment of post-menopausal symptoms are ongoing, and there...
Louis Sanfilippo, MD, President
Louis Sanfilippo, MD, President
LCS Group, LLC
Analysis of: Novel Melatonergic Antidepressant Remains Promising (www.clinicalpsychiatrynews.com)
Agomelatine (Valdoxan; Servier with rights in Europe and Novartis in the US) is a mixed melatonin (MT1 and MT2) agonist and serotonin 5-HT2c antagonist in development as a treatment for major depression and generalized anxiety disorder.  Its melatonergic properties make it unique among antidepressant...
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.

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