Med Check

The MTS will be marketed by Shire Pharmaceuticals globally. In the United States Shire will market the skin patch under the trade name Daytrana.

The FDA's approvable letter to Shire contained “proposed labeling, as well as requests for data clarification, postmarketing surveillance, and postmarketing studies,” according to a company press release. Shire said it was “initiating dialogue with the FDA to address these issues.” The company said it hopes to launch the MTS “during the first half of 2006.”

Varenicline, developed by Pfizer for smoking cessation, is a selective nicotinic-acetylcholine receptor partial agonist and is designed to bind to the same receptor sites as nicotine. By activating nicotinic receptors, the drug is believed to reduce both the severity of a smoker's craving and the withdrawal symptoms from nicotine addiction. At the same time, the drug blocks the rewarding effects of nicotine. In placebo-controlled clinical trials that included bupropion as an active comparator, 44 percent of those treated with varenicline quit smoking by the end of 12 weeks compared with 30 percent of those taking bupropion. Only 18 percent of those who received placebo quit smoking.

Pfizer has proposed the trade name Champix for the new product.

The FDA's approvable letter requested “preclinical pharmacokinetic data to support reference to existing oral naltrexone preclinical data,” according to a press release that the two companies issued jointly. Final approval is also contingent upon approval of labeling. The companies said they are “on track” to launch the product in the second quarter of 2006.

Alzheimer's patients who received testosterone had significantly greater improvements in caregiver-rated quality of life; however, no significant differences were seen between those on testosterone and those on placebo in any of the cognitive assessments. In the healthy control group, a nonsignificant trend toward greater improvement in self-rated quality of life was observed with those on testosterone compared with those on placebo. No significant differences were observed in side effects between those on testosterone and those on placebo.

Arch Neurol 2006; 63:1-9

Overall, the rate of hospitalization for VTE was 0.91 per 100 person years. Peripheral venous thrombosis accounted for 77.6 percent of hospitalizations, while 22.4 percent were for pulmonary embolisms. After adjusting for other known risk factors that may influence susceptibility to VTE, the rate of hospitalization for those taking atypical antipsychotics was 1.24 per 100 person years compared with 0.87 for nonusers. In addition, those taking risperidone were 1.98 times more likely to suffer a VTE, while those taking olanzapine were 1.89 times more likely. Patients taking clozapine or quetiapine were 2.68 times more likely than nonusers to suffer a VTE. No increased rate of VTE was associated with phenothiazine antipsychotics or other typical or first-generation drugs.

Arch Intern Med 2005; 165:2677-2682

Patients in the control group were 1.94 times more likely to have been taking an antidepressant compared with those in the suicide-attempt group. SSRIs were prescribed to 29 percent of those in the control group versus 21 percent of those in the suicide-attempt group.

Neuropsychopharmacology 2006; 31:178-181

The test, marketed by ReliaLAB, is similar to finger-stick blood glucose tests and, according to the company, is as accurate as laboratory tests on venous blood samples. A “starter kit” including the InstaRead workstation, reader, control kit, extra supplies, and 12 patient test packs retails for around $400, and a refill kit containing 24 patient test packets runs $264. More information is posted at<www.ReliaLAB.com>.