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Louis SanfilippoAugust 31, 2007
Wyeth’s Bufeprunox –Still Some Hope Here?
Analysis of: Wyeth's Schizophrenia Pill Is Rejected by U.S. FDA | www.bloomberg.com
Author: Louis Sanfilippo, President, LCS Group, LLC
The FDA’s conclusion that more data was required on bufeprunox’s efficacy and on a death that occurred is certainly a very hard setback for Wyeth. However, I think there is some legitimacy to considering that a drug that does not cause weight gain, and even might cause weight loss, that also may confer...
Louis SanfilippoAugust 31, 2007
Might BIOLINERX hold the next major class of antipsychotic medication?
Analysis of: BIOLINERX STARTS PHASE II TRIAL OF BL-1020 FOR SCHIZOPHRENIA. | www.therapeuticsdaily.com
Author: Louis Sanfilippo, President, LCS Group, LLC
BIOLINERX’s BL-1020 represents a unique class of medication for the treatment of psychotic disorders – affecting the GABA system - and the prospect of a drug that might effectively treat psychotic disoders and possibly have other applications in mood or anxiety disorders, putatively due to...
August 30, 2007
DOV 21,947: Is The Antidepressant That We Have Been Waiting For?
Analysis of: DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947 | www.pipelinereview.com
Author: Lawrence Ginsberg, President, Red Oak Psychiatry Associates, P. A.
1. Most currently marketed oral antidepressants replenish only norepinephrine or serotonin and result in remission in less than 45% of patients over 8 weeks. A triple reuptake inhibitor such as DOV 21,947 has the potential to effect a remission in a higher percentage of patients. 2. Most of the...
Louis SanfilippoAugust 30, 2007
Antidepressant, Weight-Loss Drug, and ADHD Treatment, all-in-one?
Analysis of: DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947 | www.pipelinereview.com
Author: Louis Sanfilippo, President, LCS Group, LLC
Triple Reuptake Inhibitors represent a potentially valuable new class of medications, with DOV Pharmaceuticals, GlaxoSmithKline, Neurosearch and Sepracor leading the way with Phase I and II studies in progress. While in development primarily for depression and anxiety disorders, there is interest...
August 28, 2007
Biolinerx: Issues to Consider
Analysis of: BIOLINERX STARTS PHASE II TRIAL OF BL-1020 FOR SCHIZOPHRENIA. | www.therapeuticsdaily.com
Author: Lawrence Ginsberg, President, Red Oak Psychiatry Associates, P. A.
1. An antipsychotic with a novel mechanism of action is highly desirable as currently available atypical antipsychotic agents lack efficacy or cause undesirable side effects (metabolic, extrapyramidal, increased prolactin.) 2. If this agent demonstrated significant efficacy and safety it could be a...
August 23, 2007
BL-1020 the First Novel Antipsychotic in Quite a While
Analysis of: BIOLINERX STARTS PHASE II TRIAL OF BL-1020 FOR SCHIZOPHRENIA. | www.therapeuticsdaily.com
Author: GLG Expert Contributor
1. BL-1020 represents an important advance from Israel's top drug development company 2. Unique mechanism without Parkinsonian side effects or cardiovascular, metabolic, weight gain (from atypical antipsychotics 3. This may enhance treatment adherence with better outcomes 4. Likely will be useful...
August 14, 2007
Wyeth’s Bifeprunox Bites the Dust
Analysis of: Wyeth's Schizophrenia Pill Is Rejected by U.S. FDA | www.bloomberg.com
Author: GLG Expert Contributor
The FDA requested more data to prove that Bifeprunox works in schizophrenia patients.   This is the second major blow to Wyeth in many weeks after the FDA requested additional trials to approve Pristiq for vasomotor symptoms.
August 9, 2007
Abilify is Go to Drug for Adjunctive treatment for Depression
Analysis of: ABILIFY(R) (aripiprazole) Supplemental New Drug Application Receives Priority Review by U.S. Food And Drug Administration for Adjunctive Treatment in Adults With Major Depressive Disorder | www.pipelinereview.com
Author: GLG Expert Contributor
1) Because of its excellent safety profile, enhanced side effect profile (e.g, weight gain, carbohydrate metabolism abnormalities) compared to other atypical antipsychotics such as risperdol, zyprexa and seroquel, this is an exciting 'go-to' medication 2) Best for augmentation, and one of our go-to...
August 9, 2007
wanning immunity as a future public health issue
Analysis of: Hepatitis B Vaccine Protection May Not Be Long-Lasting | www.medpagetoday.com
Author: GLG Expert Contributor
I have long been concerned about this issue - not only for Hep B, but moreover for Varicella, and measles, etc.  It is my prediction that, before the end of my medical career, immunizations will take a greater part in the Family Medicine/Internal Medicine practices, and people will need to receive...
Louis SanfilippoAugust 1, 2007
Some Clinical Observations on Shire's Vyvanse
Analysis of: Shire's New ADHD medication, VYVANSE(TM) (lisdexamfetamine dimesylate) Now Available in U.S. Pharmacies Nationwide | www.eurekalert.org
Author: Louis Sanfilippo, President, LCS Group, LLC
My previous commentaries on Vyvanse, the pro-drug amphetamine that recently entered the US market for the treatment of ADHD, was based on readings as well as discussions with colleagues; however, now I that I have a small pool of patients taking it, I am noticing a clinical profile that does separate...

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