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
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
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
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.
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>.