GLG News by QT Interval Prolongation Experts (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. 

William HaynesDirector of Clinical PharmacologyTHE UNIVERSITY OF IOWA

FDA Review of Contrave Indicates Skepticism on Cardiovascular Safety

December 3, 2010

Analysis of:FDA Briefing Document: Contrave from Orexigen Therapeutics | www.fda.gov

The release of the FDA briefing documents on Contrave (bupropion/naltrexone) highlights several areas of potential concern, including neuropsychiatric adverse events, seizures, and cardiovascular safety. Adverse events in each area were higher with Contrave and will be negatives for the committee and FDA. The most concerning issue is cardiovascular safety given increases relative to placebo in heart rate and BP, the similarity of the hemodynamic profile to sibutramine, and imbalanced CV events.

Eric GruffPrincipalE4 Consulting

The Benefits of R&D Outsourcing in Pharma and Biotech

October 1, 2010

Outsourcing of R&D activities can be a major competitive advantage for medium to large pharma/biotech companies if done correctly. While the general assumption is that outsourcing is cheaper than insourcing (also known as "do it yourself"), the total cost of outsourcing is much greater than the amount paid to the CRO for the work. There are many benefits to outsourcing, however, and when conducted in a strategic context, can provide a significant competitive advantage.

William HaynesDirector of Clinical PharmacologyTHE UNIVERSITY OF IOWA

Meridia SCOUT Results Will Impact Future Obesity Drug Approval

September 3, 2010

Analysis of:Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects — NEJM | www.nejm.org

The SCOUT trial of the weight loss medication sibutramine (Meridia; Abbott) demonstrated a significant increase in cardiovascular events compared to placebo. In addition, blood pressure and heart rate were slightly but significantly higher in patients on sibutramine than placebo. The results of this trial will likely hurt the prospects for approval of weight loss medications that share similar cardiovascular effects such as Qnexa (Vivus) and Contrave (Orexigen, Takeda Pharmaceutical).

William HaynesDirector of Clinical PharmacologyTHE UNIVERSITY OF IOWA

FDA Viewpoint on Their Approval of Liraglutide

February 18, 2010

Analysis of:Weighing Risks and Benefits of Liraglutide — The FDA's Review of a New Antidiabetic Therapy | content.nejm.org

Several important themes emerge from this FDA authored article on the rationale for the approval of liraglutide from Novo (NVO). First, they acknowledge the need for new treatments for type 2 diabetes. Second, they are clearly willing to use post-marketing surveillance to assess rare side effects. Third, the FDA considers acute pancreatitis to be a class-related side effect of GLP-1 altering drugs . These themes have implications for the future review of other drugs for type 2 diabetes.

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.

William HaynesDirector of Clinical PharmacologyTHE UNIVERSITY OF IOWA

EndoBarrier has Potential for Treatment of Obesity and Type 2 Diabetes Mellitus

November 30, 2009

Analysis of:Interim Data From A Clinical Trial Evaluating GI Dynamics' EndoBarrier™ Gastrointestinal Liner In Patients With Type 2 Diabetes | www.medicalnewstoday.com

Endoscopic placement of the EndoBarrier reduces weight by 14% and HBA1c by 1.5% after 24 weeks. While not reaching the magnitude of weight loss from bariatric surgery, these changes are impressive and substantially exceed those seen with pharmacologic monotherapy. If this efficacy is validated in future trials, and there are no safety issues, this approach could be useful for a large number of obese patients.

William HaynesDirector of Clinical PharmacologyTHE UNIVERSITY OF IOWA

New Meridia SCOUT Trial has Major Implications for Obesity Drug Development

November 23, 2009

Analysis of:FDA Ongoing Safety Review of Meridia | www.fda.gov

The recent FDA release of preliminary data from the first large-scale, randomized, cardiovascular outcome trial ever conducted for the treatment of obesity comes as a shock. While full data are not available (and the level statistical significance was not given), the fact that cardiovascular events increased rather than decreased with an obesity treatment that is at least moderately effective in reducing weight is an unwelcome surprise. Major changes in FDA review of new obesity drugs may occur.

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.     

Page : 12345Next1 to 10 of 50