Dr. Brian Kaplan MD, FACS

GLG News by Dr. Brian Kaplan MD, FACS, Chairman, Department of Otolaryngology

GLG News is now G+ Insights

G+ is a community for professionals, academics and entrepreneurs to connect through online discussions and in-person meetings. You will continue to see G+ Insights (formerly GLG News) here as well as on the G+ website, where you can share and discuss the G+ Insights you read.

Another chink in the branded PPI armor

June 23, 2009

Analysis of:Nycomed receives Marketing Authorization for Pantoprazole 20mg OTC from European Commission | www.pharmanews.eu

With the coming application for OTC status in the U.S. (after the EU) this will be another blow against the branded PPI market.  With efficacious OTC options, 3rd party payers will continue to put up obstacles to both branded and BID dosing.

Interesting, but be careful with the interpretation

May 13, 2008

Analysis of:SinuNase Fast-Tracked Pivotal Phase 3 Study in Chronic Sinusitis Shows Statistically Significant Objective Evidence of Superiority of SinuNase Over Control Lavage in Severe Cases | pharmalive.com

There are interesting findings presented from the phase 3 study.  However, great care should be used in the analysis as it is fairly easy to spin this in a positive direction which may not correlate with a patient's symptomatic improvement.

An issue of prescription coverage

March 5, 2008

Analysis of:FDA Approves Nexium for Use in Children Ages 1-11 Years | pharmalive.com

The approval of the pediatric indication for nexium gives a useful alternative to Prevacid.  However, this is already a crowded field where managed care often dictates which PPI is used.  This will likely steal some market share from Prevacid, but will probably be a small addition to Nexium's total sales.

Different Spin On Same Story

December 7, 2007

Analysis of:Antibiotics and Topical Nasal Steroid for Treatment of Acute Maxillary Sinusitis | jama.ama-assn.org

This article highlights the problems facing studies looking at the treatment of acute sinusitis.  Many in big pharma tout excellent efficacy rates for their products treating uncomplicated acute bacterial sinusitis.  In reality, the vast majority of these patients would improve with conservative management alone.

The European Veramyst - but ocular symptom control raises questions

October 29, 2007

Analysis of:New Allergic Rhinitis Treatment Avamys™ Receives Positive Opinion In Europe | www.medicalnewstoday.com

This is the European equivalent of Veramyst.  The control of ocular symptoms is a major marketing push but raises a few questions.  There are concerns regarding cataract formation with the higher potency steroid molecules.  Although low bioavailability is shown, there must be some direct ocular effect to allow symptom control compared to other inhaled nasal steroids.  Whether this is an increased side-effect of this compound, or rather that Glaxo simply sought FDA approval bringing this issue to greater prominence remains to be seen.

Don't jump on board too quickly....

June 6, 2007

Analysis of:Aspire Medical Announces First Implant In US And Start Of Clinical Trial To Treat Sleep Apnea | www.medicalnewstoday.com

This product has the potiental to address a very difficult problem for those diagnosed with OSA.  However, OSA is a spectrum of both symptoms and sites of obstruction, and one technique will not be applicable to the population as a whole

Managed Care Difficulties

May 31, 2007

Analysis of:FDA Approves XYZAL(R) (Levocetirizine Dihydrochloride) Tablets For The Relief Of Seasonal And Year Round Allergies, And Chronic Hives | www.medicalnewstoday.com

This approval follows the trend of the active metabolite being approved once the original medication goes off-patent.  There is often no additional efficacy, and with more generic alternatives availabe with equal effect, managed care will likely increase pressure to move away from these products towards the less-expensive, and often equally effective generic options.

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