Cipher requests FDA input on isotretinoin trial
WASHINGTON Cipher Pharmaceuticals has requested a meeting with the Food and Drug Administration’s Division of Dermatology and Dental Products to discuss the agency’s views of a phase III safety study to support a modified version of the acne medication isotretinoin.
The drug, CIP-isotretinoin, provides more consistent absorption compared with existing isotretinoin products on the market. In May 2006, Cipher received an approvable letter from the FDA pertaining to its application for CIP-isotretinoin. Cipher submitted its response in October 2006 and received a second approvable letter in April 2007.
In June 2007, Cipher appealed the FDA’s approvable letter for CIP-isotretinoin, which is sold by Roche under the brand name Accutane. The company has met twice since then with the FDA as part of the first stage of the formal dispute resolution process.
In its most recent response to Cipher, an FDA representative agreed with DDDP’s original view that an additional clinical safety study is needed. The company’s request for a meeting with the division means the dispute-resolution process has been put on hold. Larry Andrews, Cipher president and chief executive officer, said the company expects to meet with the FDA in late January.
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.