Trends-in-MedicineLynne Peterson,
Senior Writer
Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter.
Copyright© 2003
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Refractive Surgery Update
Summary: Instead of a summer slump in refractive surgery procedures, there has been a pickup the past three months, due in large part to wavefront technology, but it is doubtful that this level can be sustained through the end of the year. The outlook is for 2003 procedure volume to be only slightly ahead of 2002, and if the economy stumbles at all, that would lower estimates. Wavefront is increasing procedure prices, but patients reportedly are not balking at an additional $200-$350+ per eye. The conversion to wavefront may be going faster than expected; and doctors with wavefront available are now using that technology for more than half of all their procedures.
American Society for Bone and Mineral Research
Summary: The PaTH study found no additive or synergistic effect of combining NPS’s Preos with Merck’s Fosamax, and there may even be a negative effect to the combination, but the trial did not affect the attitude of doctors toward use of either Preos or Lilly’s Forteo, though they plan to stop both bisphosphenates and SERMs while giving PTH. Prior therapy with bisphosphenates -- more than with SERMs – appears to blunt the effect of PTH, but the long half-life of bisphosphenates makes it difficult to put prospective PTH patients through a wash-out period. Lilly will try to convince doctors this is a reason to start low risk patients on Evista instead of a bisphosphenate, but doctors generally consider this a marketing gimmick, and no significant market share shift due to this is expected. Doctors are not surprised at the uptake of Lilly’s Forteo, and they predicted that use will continue to increase.
European Society of Cardiology
Summary: The European Society of Cardiology meeting was an opportunity to update developments on many fronts, from BNP testing, closure device and drug-eluting stents to AstraZeneca's Crestor and Exanta, CV Therapeutics' Ranexa, Pfizer's Inspra and Lipitor -- and much more. Data from the CHARM and EUROPA trials were also presented.
American Urogynecologic Society
Summary: Lilly’s duloxetine will require PK, preclinical (in vitro and in vivo) and clinical testing before approval for the treatment of incontinence. The concern appears to be drug-drug interactions because of the way the drug is metabolized – CPY450, particularly the 2D6 and 1A2 pathways. Johnson & Johnson/Gynecare’s TVT remains the most popular vaginal sling system for stress incontinence. Ob-gyns have little interest in newer systems, none of which appears to be gaining much traction in the market. Ob-gyns are very interested in Watson’s Oxytrol patch, and sources predicted that their usage would double to ~38% of their overactive bladder (OAB) patients within a year. Johnson & Johnson reportedly is exploring the idea of taking regular Ditropan (oxybutynin) over-the-counter.
FDA PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE Meeting on Cephalon’s Provigil (modafinil) - Quick Pulse
Summary: The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted on Thursday, September 25, 2003, to recommend that Cephalon’s Provigil (modafinil) get an expanded label, but not necessarily quite as broad as the company wants. This report reviews the FDA's concerns, panel votes and comments, and the oulook for the drug.
FDA PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE MEETING on Forest Laboratories’ Namenda (memantine) - Quick Pulse
Summary: Compared to other advisory committee meetings, the memantine panel was small, relatively uncontroversial and somewhat shorter than usual. It was a big win for Forest – the panel voted unanimously in favor of memantine and Forest on every questioned posed by the FDA This report looks at the key issues with memantine, panel votes and comments, and the post-approval outlook.
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