Trends-in-Medicine| Publisher: | Stephen Snyder |
| Writers: | Lynne Peterson |
| Marta Weber | |
| Diana Woods | |
| Editors: | Kathleen Snyder |
| Betty Teel | |
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© 2004
No articles may be reproduced without written permission of the publisher.
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Shire Pharmaceuticals' Adderall XR for ADHD: Off the Market in Canada - Quick Pulse
Summary: On February 10, 2005, Health Canada ordered Shire’s Adderall XR, a drug used to treat ADHD (attention-deficit/hyperactivity disorder) off the Canadian market, citing concerns about an association with “sudden deaths, heart-related deaths, and strokes in children and adults taking usual recommended doses.” This report looks at U.S. reaction -- by consumers, consuemr gorups, and the FDA.
Inspire Pharmaceuticals' Diquafosol For Dry Eye: Fails Phase III Trial - Quick Pulse
Summary: A January 2005 issue of Trends-in-Medicine warned that Inspire’s dry eye treatment, diquafosol (INS365) was likely to fail in its latest Phase III trial, and the company announced on February 9, 2005, that, as expected, the trial did not meet its primary endpoint. This makes it unlikely that diquafosol will be approved for dry eye by the FDA – or European regulators – without an additional trial.
Cardiac Surgery UpdateSummary: Percutaneous heart valves may be the technology of the future, but it’s not the near future. Cardiothoracic surgeons are convinced these devices are 5-10 years away. Edwards Lifesciences appears to have the lead in aortic valves, but 3F Therapeutics could be the dark horse. Surgeons were surprisingly positive about Acorn’s CorCap CDS ventricular restraint device and Viacor’s PTMA. The market for cardiac assist devices simply hasn’t taken off, and doctors don’t think it will in the near future. Axial/ continuous flow left ventricular assist devices are taking the lead from pulsatile devices, and Thoratec’s HeartMate-II appears to have the lead in this area, though doctors think it is only an incremental improvement, not a technological leap forward.
Cosmetic Surgery UpdateSummary: Use of Allergan’s Botox continues to grow, and Inamed’s competing product, Reloxin, is about two years away. Doctors are not dissatisfied with Allergan, but they would switch quickly and substantially to from Botox to Reloxin if Reloxin is priced at least 10% less than Botox. Medicis’ Restylane has captured a lion’s share of the dermal filler market. Inamed’s Captique is not considered a threat to Restylane, but Inamed’s Juvederm could be – but it appears to be about two years away. Cosmetic surgeons would like the FDA to allow silicone breast implants back on the U.S. market, but they are dubious that it will happen this year. There is no pent-up demand for silicone implants, and if they are approved, doctors predicted they will capture about a third of the market in the first year, about 40% in the second year, and half the market by the third year, but use may stabilize there for a while.
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