Med Check

The Food and Drug Administration (FDA) in June approved Namenda XR (memantine) for the treatment of moderate to severe dementia of the Alzheimer's type. Namenda XR, marketed by Forest Laboratories and Merz Pharmaceuticals, is a 28 mg extended-release formulation of Namenda taken daily.

In June the FDA approved the first generic version of Effexor XR capsules (venlafaxine) to treat major depressive disorder. Venlafaxine extended-release capsules in 37.5 mg, 75 mg, and 150 mg strengths have been approved to be manufactured by Teva Pharmaceuticals. The prescribing information for the generic drug may differ from that of Effexor XR capsules, however, because some uses of the drug and parts of the label are protected by patents and/or exclusivity held by Effexor's manufacturer, Wyeth Pharmaceuticals Inc. Generic venlafaxine will have the same safety warnings as Effexor XR.

The prescribing information for Zyprexa (olanzapine) in tablet, orally disintegrating tablet, and injectable forms was revised in May to include safety precautions about the potential for orthostatic hypotension with the concomitant administration of intramuscular olanzapine and parenteral benzodiazepine, and about the potential for increased serum alanine aminotransferase (ALT) levels in adults and adolescents treated with olanzapine.

Details of the labeling revision are posted at <www.fda.gov/Safety/MedWatch/SafetyInformation/ucm215621.htm>.

Ortho-McNeil-Janssen and the FDA notified health care professionals of changes to the warnings section of the prescribing information for tramadol, a centrally acting synthetic opioid analgesic indicated for the management of moderate to moderately severe chronic pain. The revised wording warns of the risk of overdose and emphasizes the risk of suicide for patients who are prone to addiction or taking tranquilizers or antidepressant drugs.

Details of the labeling change are posted at <www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM213265.pdf>.

AstraZeneca and Targacept announced in June the enrollment of the first patient in the phase 3 clinical development program for TC-5214, a nicotinic channel blocker. The phase 3 program, referred to as the Renaissance Program, is designed to support the planned second half of a 2012 filing of a new drug application with the FDA for TC-5214 as an adjunct treatment for major depressive disorder in patients with an inadequate response to first-line therapy with a selective serotonin reuptake inhibitor or serotonin/norephinephrine reuptake inhibitor.

Orion Corporation and Selvita have agreed to collaborate on further research and development of Selvita's SEL103 program for the symptomatic treatment of Alzheimer's disease. Under the terms of the agreement, Selvita will be responsible for the discovery and early preclinical development of small molecules and will receive upfront and research funding as well as milestone payments from Orion, subject to the progress of the development program. After the selection of a lead compound, Orion will be responsible for the additional steps of the program with global commercialization rights.

A Mayo Clinic study found that apathy and depression significantly predict an individual's progression from mild cognitive impairment to dementia, including Alzheimer's disease and Lewy body dementia. The study was presented at the International Conference on Alzheimer's Disease in Honolulu in July.

Researchers identified 358 individuals with mild cognitive impairment and used a questionnaire to collect data on depression and apathy. They then prospectively followed individuals to the outcome of dementia for a median of 2.8 years. After adjusting for age, gender, and education, the researchers found that the individuals with mild cognitive impairment and depression had a 66 percent increased risk of developing dementia over those individuals with mild cognitive impairment without depression.

At the International Conference on Alzheimer's Disease in Honolulu in July, the Alzheimer's Association announced the launch of TrialMatch, a free, confidential, interactive tool that provides comprehensive clinical trial information and an individualized trial-matching service for people with Alzheimer's disease and related dementias. The Internet- and phone-based service debuted during the association's international conference in Honolulu. The Web site is <www.alz.org/trialmatch>, and the phone number is (800) 272-3900.

“If patients are not enrolling in trials, there can be no advances in diagnosis, treatment, and prevention, making the lack of study participants a significant public health issue,” William Thies, Ph.D., chief medical and scientific officer for the Alzheimer's Association, said in a statement. “Alzheimer's Association TrialMatch provides a first-of-its-kind service in Alzheimer's by delivering a user-friendly and individualized guide to clinical trials for people with Alzheimer's, their health care professionals, caregivers, and healthy volunteers.”