Dr. Daniel Wynn MD

GLG News by Dr. Daniel Wynn MD, Director, Clinical Research

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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. 

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.

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.

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.     

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.

"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.

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.     

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.

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.

Win for Talecris' Gamunex IVIG in Inflammatory Polyneuropathy

February 15, 2008

Analysis of:Positive Results from Phase III Trial of Gamunex in Patients with CIDP | pharmalive.com

Talecris' form of IVIG, Gamunex was studied in the largest trial of IVIG in chronic inflammatory polyradiculoneuropathy (CIDP), with more than twice as many patients moving into remission.  CIDP is a common acquired autoimmune peripheral neuropathy, which if not treated, may lead to a peripheral quadriparesis.  Gamunex showed not only a very strong treatment effect, but with a very low 0.8% incidence of serious adverse event.  This places it above other future putative B-cell therapies for CIDP in terms of tolerability.

SILENOR -- A Sleeper among Hypnotics

February 4, 2008

Analysis of:Somaxon Pharmaceuticals Submits New Drug Application For SILENOR(TM) For The Treatment Of Insomnia | www.pipelinereview.com

Somaxon Pharmaceuticals has submitted a NDA for Silenor for the treatment of insomnia.  The active ingredient is doxepin, which has been available for years.The effect of the drug can be expected to be very modest, side effects unfavorable when compared to Ambien or Lunesta, and with both significant potential side effects and drug interactions. The introduction of this sleeper puts me to sleep.  I doubt that I would ever prescribe it.  given its disadvantages, I do not see Somaxon's goal.          

Major Win For Glaxo with Xenoport for Restless Legs syndrome -- Next Blockbuster?

January 18, 2008

Analysis of:GlaxoSmithKline and XenoPort report positive top-line results of second phase 3 restless legs syndrome trial for XP13512/GSK1838262 | www.pipelinereview.com

Xenoport's trial for XP13512 in restless legs syndrome (RLS) shows strongly positive 9 month data in second phase 3  trial, should be a major win in the marketplace.  RLS represent a major unmet need, for drugs with sustained efficacy and high tolerability.

ZOSTAVAX: New Vaccine Dramatically Reduces Risk of Shingles

May 30, 2006

Analysis of:FDA Licenses New Vaccine to Reduce Older Americans’ Risk of Shingles | www.fda.gov

Shingles, an illness caused by reactivation of the chicken pox virus varicella zoster, affects 20% of Americans and can lead to the dreaded, severely painful condition post-herpetic neuralgia.

Zostavax is the first FDA approved vaccine to prevent shingles.

Up until now, no effective therapy has been available to decrease the chance of contracting shingles.  Zostavax (Merck), a live virus vaccine was shown in a trial of 38,546 patients over age 60 to increase immunity against varicella zoster virus and decreased the chance of developing shingles by 50% and the risk of post-herpetic neuralgia by two-thirds.  Routine use of Zostavax in individuals over age 60 would translate to 250,000 fewer cases of shingles per year.

Ligand's Avinza: Works Great But Will Anyone Care?

May 30, 2006

Analysis of:Investigators Present Final Results of Three Groundbreaking Trials of Ligand's Oral Morphine Sulfate Extended Release Capsules at the APS Meeting | www.docguide.com

AVINA, Ligand's 24 hour time release morphine sulfate showed better around the clock control of chronic pain and improved sleep when given once a day compared to twice a day dosed oxycodone CR in patients with low back pain.

In a second study, Avinza showed better sleep and improved pain control in patients with moderate to severe chronic osteoarthritis pain.

In the third study, Avinza improved pain, sleep and physical functioning in patients with chronic moderate-to-severe non-malignant pain.

The three studies, including over 900 patients, clearly show that 24 hour around the clock pain control is superior to twice daily dosed oxycodone CR.

REVISED: Abciximab- One Less Drug For Acute Stroke

May 30, 2006

Analysis of:AbESTT-II: High Bleeding Risk in Stroke Patients Given Abciximab | incirculation.net

AbESTT-II trial, a major phase III randomized trial of the glycoprotein IIb/IIIa inhibitor abciximab (Centocor and Eli Lilly) in acute stroke was halted prematurely due to the high rate of bleeding associated with the treatment.

Abciximab treatment shows no benefit in the acute treatment of ischemic stroke, while it did significantly increase fatal and symptomatic intracranial hemorrhage (ICH), was presented at the European Stroke Conference May 19, 2006, Brussels, Belgium.

Highlight on Keppra: Effective Seizure Control in Children

May 30, 2006

Analysis of:Double-blind placebo-controlled trial of adjunctive levetiracetam in pediatric partial seizures | www.ncbi.nlm.nih.gov

Keppra (levetiracetam LEV), a widely used anticonvulsant presently only approved in adults, showed impressive benefits in the adjunctive treatment of partial seizures in children in this placebo controlled double blind study.  Keppra reduced seizure frequency 26.8% over placebo with 44.6% of patients reaching greater than 50% reduction in seizure frequency versus only 19.6% of placebo patients (p<0.0002).  Side effects of were similar in Keppra and placebo treated patients.    

ADHD Drugs and Cardiovascular Risk

May 22, 2006

Analysis of:ADHD Drugs and Cardiovascular Risk | content.nejm.org

The use of stimulant medications to treat ADHD has well defined cardiovascular risks, including myocardial infarction, stroke and sudden cardiac death. Given the high incidence of ADHD in the general population, up to 4-6% of school age children, careful assessment of patients is always appropriate before use to minimize serious events. Cardiac risks are elevated in individuals with congenital heart disease, a condition which maybe asymptomatic. As such, the Advisory Panel recommended a black box warning for this class of pharmaceuticals.

Dextromethorphan/Quinidine -- First Proven Treatment for Pseudobulbar Affect

May 9, 2006

Analysis of:Randomized, controlled trial of dextromethorphan/quinidine for pseudobulbar affect in multiple sclerosis | www3.interscience.wiley.com

Panitch and colleagues showed in a placebo controlled, randomized, double-blind, placebo controlled 12 week trial that the combination of dextromethorphan and low dose quinidine (DM/Q) is highly effective in the treatment of pseudobulbar affect (PBA) in multiple sclerosis (MS) patients.  These trial results support the earlier trial of DM/Q in the treatment of PBA in patients with amyotrophic lateral sclerosis (ALS).  Fewer side effects were seen in the longer MS trial than in the earlier ALS trial, suggesting that DM/Q may be a very important treatment in PBA, a common condition, presently without an FDA approved medication.

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