Pozen answers FDA questions on Treximet
CHAPEL HILL, N.C. Pozen has submitted study results to answer safety concerns the Food and Drug Administration had about its migraine drug, according to published reports. Pozen also announced that the FDA has tentatively accepted a new name for the pill, changing it from Trexima to Treximet.
After satisfying questions about Treximet’s potential to cause heart attacks, stroke and genetic damage, Pozen expected the drug to pass regulatory scrutiny in August. But the FDA raised new concerns, this time about lab test results that suggested Treximet’s two ingredients may be toxic when taken together.
In October, Pozen submitted additional information about the test that raised the toxicity concerns. Now the company has followed up with study results that indicate the drug didn’t cause genetic abnormalities in patients who took the pill for seven days.
Pozen has been developing the drug with GlaxoSmithKline, who is hoping the drug will be approved before the end of the year to help keep its control of the migraine drug market after its drug Imitrex goes off patent at the end of the year.
Study shows infrared thermometer helps cut down on diabetic foot ulcers
WASHINGTON A new study published last month in the American Journal of Medicine showed that a new infrared digital thermometer decreases the chance of a diabetic receiving a foot ulcer, according to published reports.
Foot ulcers each year strike 600,000 U.S. diabetics, who are slow to notice they even have a wound because diabetes has numbed their feet. Worse, foot ulcers are so slow healing and vulnerable to infection that they’re to blame for most of the roughly 80,000 amputations of toes, feet and lower legs that diabetics undergo each year.
Using the thermometer reduced the number of high-risk patients who got foot ulcers by nearly two-thirds, according to Armstrong who studied 225 diabetic veterans.
The thermometer works by measuring the difference in temperature around the foot, looking for hot spots that can signal inflammation, which correlates to tissue injury. Patients measure half a dozen spots on each foot. When the thermometer signals a hot spot, they put up their feet for a day or so until the temperature normalizes. Easing pressure before the skin cracks lets the body heal more easily than it can with a full-blown wound.
“Heat is one of the most sensitive things, one of the first things that happens when we begin to have tissue breakdown,” says Crystal Holmes, a University of Michigan podiatrist who has begun prescribing the thermometers.
The results of the study, which took place over 18 months, showed that 12.2 percent of patients who did standard foot checks got ulcers, compared to 4.7 percent of those who used the thermometers.
The thermometer, called the TempTouch and made by Xilas, is currently available by prescription only.
AstraZeneca to conduct comparison between Crestor and Lipitor
LONDON AstraZeneca announced that it will conduct a clinical trial comparing its cholesterol-fighting drug Crestor with Pfizer’s cholesterol drug Lipitor, the world’s best selling drug, according to Reuters.
The new trial, called SATURN, would compare the drugs’ ability to reduce the progression, or induce regression, of atherosclerosis, the main cause of cardiovascular disease, following two years of treatment in patients with coronary artery disease. Crestor was recently approved by the Food and Drug Administration to fight atherosclerosis.
AstraZeneca said the first of around 1,300 patients in the SATURN trial would be enrolled later this month and the study was expected to complete in 2011.
Lipitor had sales of $12.9 billion, compared to Crestor’s $2 billion in 2006.