Formulary Watch |

First-time generic approvals (May 2006)

Terconazole vaginal supposit-ories 80 mg (equiv to Terazol 3 vaginal suppositories)

Drug Watch: Selected antibiotics in late-stage development (May 2006) (PDF)

A review of selected antibiotics in late-stage development (May 2006).

Analysis of Medicare drug plans reveals variance in value and in formularies' coverage

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.

FDA's 'Critical Path' initiative could lay groundwork for expedited drug development, quality improvement

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.

CMS addresses redundancies in Medicare drug plan as it composes formulary and coverage policies for 2007

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.

Clostridium difficile infections on rise in United States at short-stay facilities

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.

Statin therapy within 24 hours of hospital admission associatedwith lower risk of CHF and in-hospital death

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.

American College of Cardiology: 55th Annual Scientific Session focuses on continuing research, emerging clinical trial data

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.

Lymphoma risk in RA associated with inflammatory burden, not treatment

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.

Full-length human recombinant parathyroid hormone for the treatment of osteoporosis

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.

First-time generic approvals (May 2006)

Terconazole vaginal supposit-ories 80 mg (equiv to Terazol 3 vaginal suppositories)

Pipeline Preview (May 2006)

Approvable designations

FDA actions in brief

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.

Daytrana

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).

Insulin Therapy: Practical Clinical Aspects

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.

Drug Watch: Agents in late-stage development for the treatment of acute and neuropathic pain (April 2006) (PDF)

A review of selected agents in late-stage development for the treatment of acute and neuropathic pain (April 2006).

Natalizumab: FDA is concerned-should managed care be, too?

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)?

FDA aims to encourage drug development; von Eschenbach nominated as permanent head

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 resistance: a growing concern

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.)

ASA ISC 2006: Raloxifene may offer stroke protection in women with high estradiol levels

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.

ASA ISC 2006: Neuroprotectant reduces disability after ischemic stroke

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.

ASA ISC 2006: Statin withdrawal during acute phase of stroke worsens neurologic outcome

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.

Study finds <1% of prescriptions that violate black box warningscause adverse drug events

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.

First-time generic approvals (April 2006)

Cyclobenzaprine tablets 5 mg (equiv to Flexeril tablets)

Pipeline Preview (April 2006)

Parathyroid hormone (rDNA origin) (Preos, NPS Pharmaceuticals) for the treatment of osteoporosis.

FDA actions in brief

Sodium phosphate monobasic monohydrate/sodium phosphate dibasic anhydrous tablets (OsmoPrep, Salix) were approved by FDA for cleansing of the colon prior to colonoscopy in patients aged 18 years or older.

Emsam

Selegiline is an irreversible inhibitor of monoamine oxidase (MAO) whose mechanism of action in the treatment of depression is not fully understood.

Erbitux

Cetuximab binds specifically to the epidermal growth factor receptor (EGFR), a transmembrane protein expressed in many human cancers, including those of the head and neck, colon, and rectum.

Incretin hormones in the treatment of type 2 diabetes

Type 2 diabetes mellitus is a progressive disease affecting more than 18 million Americans. Incretin mimetics and DPP-IV inhibitors are new classes of antihyperglycemic agents that may improve glycemic control in patients with type 2 diabetes. The incretin hormone, glucagon-like peptide 1 (GLP-1), stimulates glucose-dependent insulin secretion, suppresses inappropriate glucagon secretion, and slows gastric motility. GLP-1 levels are decreased in type 2 diabetes. GLP-1 is rapidly inactivated by the enzyme dipeptidyl peptidase-IV (DPP-IV), resulting in a half-life of <2 minutes. Strategies to increase GLP-1 activity include the development of incretin mimetics that are resistant to DPP-IV degradation and the development of DPP-IV inhibitors. Clinical trials have demonstrated that the incretin mimetics exenatide and liraglutide, as well as the DPP-IV inhibitor vildagliptin, improve glycemic control, reduce weight, and are fairly well tolerated. Exenatide (Byetta, Amylin/Lilly) was approved by FDA in April 2005..

Lubiprostone: A novel chloride channel activator for the treatment of constipation

Lubiprostone (Amitiza, Sucampo/Takeda) was approved on January 31, 2006, for the treatment of chronic idiopathic constipation in adults when the cause of the condition is unknown. The agent has a unique mechanism of action compared with current therapies on the market in that it locally activates specific chloride channels (ClC-2) in the lining of the small intestines after oral administration, thereby increasing intestinal fluids and softening bowel movements. In double-blind, placebo-controlled trials, lubiprostone demonstrated efficacy in improving the frequency of spontaneous bowel movements and other related constipation symptoms. Lubiprostone was reported to be well tolerated in clinical trials; the most common adverse effects were mild-to-moderate nausea and headache.