Rasagiline is an irreversible monoamine oxidase (MAO) inhibitor that is thought to exert its effect by specifically inhibiting MAO-B, thereby causing an increase in the extracellular levels of dopamine in the striatum.
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Terconazole vaginal supposit-ories 80 mg (equiv to Terazol 3 vaginal suppositories)
A review of selected antibiotics in late-stage development (May 2006).
A Kaiser Family Foundation study examined formularies, drug costs, and utilization management tools in drug plans offered by 14 national and near-national organizations, which encompass 35 unique prescription drug plans that account for 1,222 of the 1,429 packages available to Medicare beneficiaries.
As part of its Critical Path initiative, FDA has released a list reporting 76 high-priority research projects designed to modernize and advance medical product development. This program's goal is to bring medical innovations to patients more quickly and at a lower cost.
In response to ongoing industry and beneficiary concerns about the Medicare Prescription Drug Plan, the Centers for Medicare and Medicaid Services (CMS) is clarifying the rules and reviewing the formularies of insurers who are applying to provide Part D coverage for next year. CMS is simultaneously crafting guidance and procedural improvements that aim to make the program operate more smoothly.
An analysis of data gathered from the National Hospital Discharge Survey (NHDS) shows that Clostridium difficile-associated disease (CDAD) rapidly increased among patients at US hospitals from 2000 to 2003, particularly among patients aged ?65 years.
Early statin use was associated with a lower risk of congestiveheart failure (CHF) development and in-hospital death in patientstreated for acute myocardial infarction (AMI), according to arecent observational study published in the International Journalof Cardiology.
The 55th Annual Scientific Session of the American College of Cardiology (ACC) assembled from March 11 to March 14, 2006, in Atlanta, Ga, to exchange new and continuing research in cardiovascular disease. The program featured more than 1,600 oral and poster presentations of original research and hundreds of invited lectures and interactive sessions, with many offering the opportunity to update attendees' knowledge of available and investigational pharmaceuticals.
A matched-case control study comparing 378 Swedish patients with rheumatoid arthritis (RA) in whom malignant lymphoma developed with a control group of 378 RA patients who did not develop lymphoma found no observed association between lymphoma risk and various methods of RA treatment, according to an article in the journal Arthritis & Rheumatism.
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Full-length or intact parathyroid hormone [rDNA origin] for injection (PTH [1-84], Preos, NPS Pharmaceuticals) is currently under FDA review for the treatment of postmenopausal osteoporosis. If approved, parathyroid hormone (1-84) will join teriparatide (PTH [1-34], Forteo, Lilly), the truncated N-terminal (1-34) form of the hormone, as the only anabolic therapies available for osteoporosis treatment.
Terconazole vaginal supposit-ories 80 mg (equiv to Terazol 3 vaginal suppositories)
Approvable designations
Naltrexone extended-release injectable suspension (Vivitrol, Alkermes/Cephalon) was approved for the treatment of alcohol dependence in patients who can abstain from drinking in an outpatient setting and who are not actively drinking at the time treatment is initiated.
This central nervous system stimulant delivered via a transdermal patch is the first and only non-oral therapy to receive approval for the treatment of attention deficit/hyperactivity disorder (ADHD).
While oral medications are the most common initial treatment of type 2 diabetes, oral monotherapy usually fails to control glucose levels over time. Findings have shown that after 3 years of monotherapy for type 2 diabetes, 50% of patients require combination therapy. After 9 years of monotherapy, that proportion rises to 75%. Nevertheless, even combination therapy eventually fails to control blood glucose levels in most patients. At this point, insulin therapy becomes necessary.
A review of selected agents in late-stage development for the treatment of acute and neuropathic pain (April 2006).
FDA officials said the agency "remains very concerned" that patients who take natalizumab (Tysabri, Biogen Idec/Elan) may develop a rare, potentially fatal brain infection called progressive multifocal leukoencephalopathy (PML). So starts a report from Reuters published on February 15, 2006. Should managed care also be concerned? If so, how should managed care formulary decision-makers respond? What is their role in managing patients who are clamoring for even more products to treat their diseases in an era in which it seems that miracles are a daily occurrence in the world of biotechnology? What role should managed care play in refereeing potentially devastating side effects for a disease that frightens patients as much as multiple sclerosis (MS)?
Last month FDA unveiled a long-awaited list of collaborative projects to streamline and accelerate the development of new medical treatments. Then Health and Human Services (HHS) Secretary Mike Leavitt joined Andrew von Eschenbach, MD, and Deputy Commissioner Janet Woodcock, MD, in urging implementation of the Critical Path initiative. Dr von Eschenbach, who hopes to oversee this effort as permanent FDA head following his official nomination to the position, says he is committed to fully implementing the initiative in order to "dramatically increase the success rate in moving products from the lab to the patient."
Aspirin is the cornerstone of therapy in the treatment and prevention of cardiovascular disease. The potential benefit of aspirin therapy may be significantly reduced in patients with aspirin resistance, creating a clinical and economic burden on the healthcare system. The purpose of this article is to clarify the term "aspirin resistance," describe the proposed mechanisms, review the clinical outcome studies with associated resistance testing, and discuss the potential pharmacologic management of this problem. Literature searches were performed using MEDLINE (January 1966 to January 2006) for review articles on aspirin resistance and antiplatelet activity. Aspirin's primary mechanism of action is to irreversibly inhibit cyclooxygenase-1 (COX-1); however, there are reports of alternative biochemical pathways producing platelet aggregation. The addition of thienopyridines to aspirin should be considered for the management of aspirin-resistant patients. (Formulary. 2006;41:192–201.)
In a post-hoc analysis, raloxifene (Evista, multiple manufacturers) appeared to attenuate stroke risk caused by high estradiol levels in postmenopausal women, said Jennifer S. Lee, MD, at the American Stroke Association's International Stroke Conference 2006 in Kissimmee, Fla.
An investigational free-radical trapping agent, NXY-059, significantly reduced disability when given within 6 hours of acute ischemic stroke, said Kennedy R. Lees, MD, at the American Stroke Association's International Stroke Conference 2006 in Kissimmee, Fla.
Withdrawing statins during the acute phase of ischemic stroke is associated with worse neurologic outcomes and larger brain injury compared with acute stroke patients who remain on their statins, said Florentino Nombela, MD, at the American Stroke Association's International Stroke Conference 2006 in Kissimmee, Fla.
An observational study of 51 outpatient practices found that about7 in 1,000 outpatients were administered a prescription thatviolated an FDA black box warning and that <1% of those patientshad an adverse drug event (ADE) as a result.
Cyclobenzaprine tablets 5 mg (equiv to Flexeril tablets)
Parathyroid hormone (rDNA origin) (Preos, NPS Pharmaceuticals) for the treatment of osteoporosis.
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