GLG News by Neurologists (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. 

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.

Josef ParviziAssistant Professor of Neurology Stanford University Medical Center

Multiple Sclerosis: Told him to get up and walk and the man did so!Patients with multiple sclerosis may benefit from taking a bird poison? Potassium channel blockers in multiple sclerosis

May 29, 2009

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

Patients with multiple sclerosis may benefit from taking a bird poison? Potassium channel blockers in multiple sclerosis 

Daniel WynnDirector, Clinical ResearchCONSULTANTS IN NEUROLOGY LTD

"Tamper-Proof" -- A Significant Gain to Whom??

November 17, 2008

Analysis of:FDA Asks if Pain Pill Is Tamper-Proof | online.wsj.com

Abuse resistant long acting narcotics offer benefit as they are less desirable to those who might wish a quick high via snorting, injecting crushed time-release narcotic. Unfortunately, given the higher cost than long acting generics and increased pressure on physicians to prescribe generics, expect pick up in the marketplace (assuming approval) to be slow.

Daniel WynnDirector, Clinical ResearchCONSULTANTS IN NEUROLOGY LTD

Novartis and Multiple Sclerosis: A Major Commitment

June 5, 2008

Analysis of:Extavia® approved in E.U for treatment of multiple sclerosis, first in planned portfolio of therapies from Novartis | www.asia-manufacturing.com

Extavia, Novartis' brand of  interferon beta 1b, has been approved for the  treatment of multiple sclerosis by the European Union.  With FTY72, Fingolimod, Novartis has the eye on filing NDA by the end of 2009.  While essentially identical to Bayer's Betaferon interferon beta 1b, and similar to EMD Serono's Rebif and Biogen's Avonex, Extavia does not offer a new therapy to MS patients, simply a new face.  With this launch, Novartis presumably hopes to work closer to key opinion leaders in multiple sclerosis, allowing an accelerated launch of Fingolimod.     

Daniel WynnDirector, Clinical ResearchCONSULTANTS IN NEUROLOGY LTD

Abbott's ABT-089 --Much More than a Treatment for ADHD

June 2, 2008

Analysis of:Abbott Scientists Present A New Approach for Treating Attention-Deficit Hyperactivity Disorder | biz.yahoo.com

The data on ABT-089 in adults has been released with positive results, whereas the adolescent/childhood trial is on-going for this novel compound for ADHD.  The key difference is the potential to improve learning, not simply regain attention and lessen hyperactivity.

Daniel WynnDirector, Clinical ResearchCONSULTANTS IN NEUROLOGY LTD

COPAXONE from the START of MS

April 24, 2008

Analysis of:Teva Seeks Approval for the Extension of its Indication to Include the Treatment of Patients with a First Clinical Event Suggestive of MS | www.pipelinereview.com

Copaxone has become the leading treatment for relapsing remitting MS in the US.  The results of the PRECISE trial will likely add to TEVA's sales momentum and boost sales further.

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