Pharmacy & Therapeutics - March 2009 - (Page 136) NEW DRUGS Nanobodies have performed well. The drug is in phase 1 of human clinical trials. Ablynx is developing 24 different antibody-based drugs. The company prefers llamas to camels because they are less expensive and easier to buy in Europe. Source: The Wall Street Journal, February 17, 2009 DRUG NEWS Brain Device Treats Obsessive–Compulsive Disorder The FDA has approved the first implantable device designed to deliver electrical therapy to the brain to suppress symptoms associated with chronic, severe obsessive–compulsive disorder (OCD). Medtronic’s Reclaim DBS (deep brain stimulation) Therapy is indicated when drug and psycho therapy have failed. Reclaim DBS is the first psychiatric indication to be approved for DBS. Collaborative clinical research on DBS therapy using Medtronic devices began in 1998 with the first implant in Europe. Research was also conducted at three medical centers in the U.S. DBS therapy was studied in 26 patients with severe, treatment-resistant OCD. The long-term results revealed symptom reductions and functional improvement in two-thirds of patients. Most of these patients improved from a severe OCD rating at the start of the study to a mild or moderate rating at various follow-up intervals after the device was implanted. Reductions in OCD symptoms were associated with improvements in psychological, social, and occupational domains. A total of 23 serious adverse events were reported in 11 subjects (42%); 15 of these 23 events were associated with the surgical implant procedure, the device, or therapy, and all of these events were resolved without further complications. Adverse events, such as anxiety and changes in mood, were transient, and most of these events resolved with adjustments in stimulation parameters. It is anticipated that Medtronic’s Rclaim DBS Therapy will be used in fewer than 4,000 patients annually for treating OCD. The device is expected to be available in mid-2009. Sources: Molec Psychiatry; Medical News Today, February 20, 2009 tified all participants with anomalies and cleared all healthy volunteers. The compact size and low cost of MARIA should make it ideal for use in hospitals, diagnostic centers, mobile screening units, and developing countries, where the cost of screening with x-rays is a barrier. Source: R&D Magazine, February 12, 2009 Radio Waves May Detect Early Breast Cancer The use of radio waves may become a new, safe way to record images of breast cancers. Mammograms can miss 15% to 20% of breast cancers that are not visible, especially in younger women. With x-rays, it is difficult to distinguish normal fibrous and glandular tissues from cancerous tissue, because their densities are similar. In older women, fibrous and glandular tissues diminish, leaving mainly fatty tissues. Mammography in older women is thought to be more effective, because small cancers are easier to detect in fatty tissue. In the 1990s, research from the University of Bristol in the United Kingdom was being conducted to study the treatment of breast cancers with microwaves by measuring the electrical properties of breast tissue. It was known that tumors had certain electrical properties. Micrima, a company that was formed in 2006, has developed a technique known as MARIA (Multistatic Array processing for Radio-wave Image Acquisition). MARIA captures high-resolution, three-dimensional images of the breast via harmless radio waves. Tumors as small as 2 mm across can be detected. Breast compression is not required with MARIA, as in mammography. The transmitted radio wave signal has a power of less than 1 milliwatt, which is considered a very safe exposure. The procedure can be repeated as often as necessary. In initial trials, MARIA correctly iden- DEVICES IN THE NEWS Ablation Catheters For Atrial Fibrillation The first ablation catheters for treating patients with atrial fibrillation (AFib) have been approved. AFib affects more than two million Americans. The NaviStar ThermoCool salineirrigated radiofrequency ablation catheter and the EZ Steer ThermoCool Nav (BioSense Webster), create small, strategically placed scars in heart tissue to block irregular electrical waves that cause AFib. The FDA had previously approved other ablation catheters to treat patients with atrial flutter and ventricular tachyarrhythmia but not AFib. Patients are usually treated with drugs or, in rare cases, with open-heart surgery. Catheter ablation should be used only after drug treatment has failed to control symptoms. Although AFib is a risk factor for stroke, there is no evidence linking ablation to a reduction in stroke. Therefore, the FDA recommends that patients at risk for stroke continue to take anticoagulant medications after ablation procedures for AFib. In a clinical study, the catheters were effective in eliminating symptomatic recurrence of AFib episodes for one year in 63% of treated patients but in only 17% of controls. As a condition of the device approval, BioSense Webster must establish a physician-training program and must conduct postmarketing safety studies. Source: FDA News, February 6, 2009 136 P&T® • March 2009 • Vol. 34 No. 3
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