Drug Pipeline

Fondaparinux, the first in a new class of antithrombotics that selectively target factor Xa, has been deemed approvable by the FDA for prevention of venous thromboembolism following orthopedic surgery. Four phase III trials have suggested that it may be more effective than enoxaparin in this setting with little to no additional bleeding risk. This Focus review examines data from these trials and others in an effort to sketch out this pending agent's likely therapeutic role.

New Formulations/Combinations: Pediatric-specific albuterol formulation; fixed-dose bronchodilator combination

New Indication: Light-activated ophthalmic cleared for CNV due to two additional causes

New Indication: Injectable PPI cleared for hypersecretion due to Zollinger-Ellison syndrome

NMEs/biologics:First nucleotide analog for treatment of HIV-1 infection; dosed once daily

NMEs/biologics: 5-HT receptor agonist for Tx of migraine

Uncle Sam is poised to authorize more than $1 billion to buy medicines and vaccines for the national pharmaceutical stockpile, and federal agencies are gearing up to spend millions more on research related to infectious disease. In response, the pharmaceutical industry is assessing how these developments may alter the way it does business.

In less than 2 weeks after the launch of generic fluoxetine in August, Merck-Medco had switched 85% of its mail-order Prozac prescriptions to generic versions of the antidepressant. It says its generic switch rate for retail Prozac scripts was 69% over the same time period.

The September 11 terrorist attacks and October's wave of anthrax cases have forced hospitals and health systems to examine their emergency preparedness from a new perspective. When it comes to planning for possible shortages of critical drugs and the need for biodefense, experts say the right mix of federal guidance and local implementation is key.

Combination use with ribavirin for chronic hepatitis C

Harvard Pilgrim HealthCare, Wellesley, MA-It's well accepted that the provision of drug samples influences physician prescribing practices. Annually, the pharmaceutical industry provides billions of dollars worth of drug samples to physicians' offices and studies have shown the effectiveness of sample medications in shaping physician prescribing patterns.

New Formulations/Combinations: Hormonal vaginal contraceptive ring

New Formulations/Combinations: Oral form of corticosteroid for Tx of mild to moderate Crohn's disease

New Indication: Maintenance treatment of COPD

New Indication: Hepatitis B indication expanded to pediatric patients

NMEs/biologics:Cephalosporin for various infections

NMEs/biologics: Longer-lasting erythropoietin product for anemia related to renal failure

With the government spending billions to fight terrorism at home and abroad, federal investigators are looking closely at all health care programs for opportunities to stymie abuses and collect big penalties.

Interferon alfa-2b and the nucleoside analog lamivudine are the currently available options for treating chronic hepatitis B virus (HBV) infection. This article reviews major efficacy findings with these agents, defines their role according to patients' clinical status, and provides the latest data on optimal duration of therapy, predictors of response, and long-term effects. The authors also explore the emergence of hepatitis B immune globulin for post-liver transplant HBV prophylaxis and offer a progress report on experimental therapies for chronic HBV infection.

University Hospital and Medical Center (Tamarac)/University of Florida (Gainesville)-Dalteparin appears to be at least as clinically effective as enoxaparin for the prevention or treatment of the consequences of venous and arterial thromboembolic diseases, say clinicians from these two facilities.

New Formulations/Combinations: Fixed-dose analgesic combination for short-term acute pain management

New Indication: Combination use with docetaxel for breast cancer; new black box

New Indication: Antiepileptic cleared for Lennox-Gastaut syndrome; glaucoma warning added

New Indication: Oral contraceptive approved for acne

New Indication: Low-dose t-PA for catheter clearance

NMEs/biologics:Short-infusion bisphosphonate for hypercalcemia of malignancy

Minneapolis Veterans Administration Medical Center-Decreasing or eliminating the use of alprostadil-based erectile dysfunction treatments and converting to 100% sildenafil use would save this VA medical center more than $101,000 annually. Furthermore, the projected savings would allow an additional 405 men with erectile dysfunction to be treated for an entire year, say clinicians at this facility.

Patients' adherence ability is by far the top patient factor guiding selection of a first-line antiretroviral regimen for HIV, according to a new physician survey.

For the first time, a large clinical trial has shown that a medication can help prevent type 2 diabetes in high-risk individuals. At the same time, drug therapy emerged as a less effective preventive strategy than fairly modest diet and exercise changes.

Abciximab reduces nonfatal outcomes as part of a new reperfusion regimen for acute myocardial infarction (MI) but appears not to benefit patients with acute coronary syndromes who don't undergo early revascularization.