GLG News by Physicians who Treat Insomnia (US)

Daniel WynnDirector, Clinical ResearchCONSULTANTS IN NEUROLOGY LTD

Central Neuropathic Pain: Cymbalta--- Another Failed Trial

December 29, 2010

Analysis of:Duloxetine in patients with central neuropathic pain caused by spinal cord injury or stroke: A randomized, double-blind, placebo-controlled trial. | www.ncbi.nlm.nih.gov

Treatment of neuropathic pain remains an enigmatic dilemma for most physicians.  Presently there are no drugs FDA approved for central neuropathic pain.  The use of drugs utilized for diabetic peripheral neuropathy and fibromyalgia, most notably Cymbalta (Eli Lilly), Lyrica (Pfizer) and Savella (Forest), as well as generics such as  gabapentin, tricyclic antidepressants and older anticonvulsants remain the mainstay of therapy. 

David ZimmermanPresident/OwnerDoctors of Pharmacy, Inc.

CVS vs. Walgreen's and the latest....

June 12, 2010

As a consultant and clinical pharmacist with over 30 years experience, I am glad someone.... and in this case... Walgreen's finally woke up to fees that are insulting low and a losing proposition. It has been well established the the "average expense to dispense a prescription" (the pharmacy's actual costs including rent, payroll, overhead, etc) is in the $10 range per prescription. Why would any pharmacy sign a contract with a fee of $1.50 per prescription?

Daniel WynnDirector, Clinical ResearchCONSULTANTS IN NEUROLOGY LTD

Fampridine-PR -- The First Drug Proven to Help Multiple Sclerosis Patients Walk!

January 19, 2010

Analysis of:Biogen Idec Submits Application in Europe for the Approval of Fampridine-PR Tablets to Improve Walking Ability in People with Multiple Sclerosis | www.pipelinereview.com

Being confined to a wheelchair is the most common fear of patients living with multiple sclerosis (MS) from the time of diagnosis.  Up until now, there have been no therapies demonstrated to improve walking in multiple sclerosis.Fampridine-PR is the first drug application for a product which has clearly shown to improve walking speed in a significant portion of MS patients, and may become the first drug specifically approved for this indication.

Daniel WynnDirector, Clinical ResearchCONSULTANTS IN NEUROLOGY LTD

Acorda's Fampridine: The First FDA Approval to Help MS Patient's Walk

December 14, 2009

Analysis of:FDA Questions Efficacy of Acorda's MS Drug (Fampridine SR) | www.thestreet.com

Fampridine SR improves multiple sclerosis patient's ability to walk.  In demonstrating this, Acorda has successfully demonstrated that a new class of therapeutics, potassium channel blockers, can be effectively employed to address MS symptoms effectively and safely.

Daniel WynnDirector, Clinical ResearchCONSULTANTS IN NEUROLOGY LTD

Fampridine-SR -- anxiously awaited new MS therapeutic

June 2, 2009

Analysis of:Acorda’s Fampridine-SR Gets Priority Review | phoenix.corporate-ir.net

A major unmet need in the treatment of Multiple Sclerosis is a medication to increase walking ability.  Since disease modifying therapies have only been available for 16 years, MS starts at a mean age of 29, and the disease has only a minimal effect at shortening lifespan, the majority of MS patients presently have progressive forms of MS.  Ten percent have primary progressive disease, progressive from the onset, and others, start with relapsing remitting MS, and progress after approximately 15 years to progressive illness.  In the early years of progressive MS, patients loose the ability to walk, hence the prior motto of the National MS Society, "MS, the great crippler of young adults."  FAMPRIDINE SR IS THE FIRST MEDICATION FOUND TO IMPROVE MS PATIENTS ABILITY TO WALK.  Standard disease modifying agents, the interferons (Avonex, Betaseron, Rebif), Copaxone and Tysabri, decrease relapse rate and may slow progression, however do not improve one's ability to walk.     

Daniel WynnDirector, Clinical ResearchCONSULTANTS IN NEUROLOGY LTD

NUVIGIL for Jet Lag -- An Important Broad New Indication for Cephalon

June 2, 2009

Analysis of:Cephalon to apply for FDA approval for Nuvigil for jet lag | www.reuters.com

NUVIGIL, Cephalon's single isomer longer effective half-life follow-up product to Provigil is coming to market only after careful strategic planning.  While extremely successful, Provigil, a unique wake promoting agent, suffered in many ways.  When introduced, it had only FDA approval for narcolepsy, a relatively uncommon, yet severe sleep disorder.  Sales increased markedly when Provigil became approved for other common conditions associated with excessive daytime sleepiness (EDS), treated obstructive sleep apnea with residual EDS and sleep wake shift disturbance (SWSD). If approved for Jet Lag, there is the promise that Nuvigil will become available for an increasing enlarging marketplace.

Edward LisbergDirectorAsthma and Allergy Center of Chicago, S.C.

Qforma's Online Database: Exposing Pharma's Physician Marketers?

May 15, 2009

Analysis of:In patients' hunt for care, doctor database 'a place to start' | www.usatoday.com

undefinedundefined undefined If the Qfarma database makes public those physicians with significant financial conflicts of interest, will this lead to more intense regulatory  scrutiny of these physicians?  Does this online database place at risk the industry practices?

Alan PattersonObstetrician and GynecologistALAN B PATTERSON MD, PA

Sequenom's delay

May 4, 2009

Analysis of:UPDATE 2-Sequenom delays Down Syndrome test; shares plunge | uk.reuters.com

This delay is not good for the company, especially since there are already tests in place that are effective to screen for Down's syndrome.  These tests now are the standard of care, so the longer it takes for Sequenon to launch it's test the worse, for the company.

Edward LisbergDirectorAsthma and Allergy Center of Chicago, S.C.

LABA daba done?

December 11, 2008

Analysis of:FDA: Long-Acting Asthma Drugs Increase Asthma Risks | online.wsj.com

Some information of note, the current FDA briefing document (http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4398b1-00-index.htm) is a publication entirely created by GSK,  Novartis, and AstraZeneca and not an independently created FDA review.  It merely is a summary of trials data already published; in as much, there may be other unpublished data by these pharma co's that may be relevant but will not be part of the debate.  Absent from the FDA document are the FDA reviewer's comments..?redacted.  Furthermore, none of the individual SAE reports are included for review and analysis; we are again left only with pharma's version and clinical trials interpretation. 

Robert ArisProfessor of MedicineUniversity of North Carolina at Chapel Hill School of Medicine - CC

Oral Treprostinil: An effective medicine hiding in a study with a challenging design?

November 18, 2008

Analysis of:Freedom-C Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Fails to Meet Primary Endpoint | ir.unither.com

This phase III study was done without the benefit of conventional drug development with Phase I and Phase II studies (which would have provided more information about the effective dose) preceding it because pharmacokinetic date from IV and SC dosing studies were used to extrapolate for the oral dosing. While in hindsight, this may have not been ideal, the trial holds a lot of promise that treprostinil will be effective since there was a nice dose-response curve and the higher doses clearly appeared to be effective. Oral Treprostinil is probably very similar to subcutaneous and intravenous prostanoids (remodulin and flolan) that require a slow uptitration of dose to allow the patient to become tolerant to the side effects. Thus having smaller doses for titration, which were available later in the trial, probably would have allowed for greater success had these doses been available earlier in the study.

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