Drug Pipeline

Raising the antimicrobial concentration at the site of the infection has recently been identified as an important factor in combating bacterial resistance. Low in vitro concentrations of mlactams can eliminate susceptible pathogens but can augment resistant populations.

The mechanisms of bacterial resistance vary from one antibiotic to another and from one organism to another. There are several mechanisms of antibiotic resistance.

Application of the pharmacokinetic and pharmacodynamic characteristics of antibiotics to prescribing practices can help determine which antimicrobial to select for effective bacterial eradication and to reduce the development of antimicrobial resistance.

Guidelines for antibiotic prescribing were developed because antibiotic resistance has increased steadily over the years since these agents were first introduced, in large part due to antimicrobial overuse.

Antipsychotic administered as 1 injection every 2 weeks

Biologic therapy for continuous control of plaque psoriasis

New PDE5 inhibitor approved for erectile dysfunction

QD or BID administration without food or water restrictions

An intravenous formulation of lansoprazole has been developed and is under review by FDA. If approved, lansoprazole will be the second IV proton pump inhibitor available in the United States, providing an alternative to the currently available pantoprazole IV. The pharmacokinetic and pharmacodynamic properties of lansoprazole IV have been found to be comparable to the oral form. Until more data are available the agent, if approved, should be reserved as an option for patients unable to take lansoprazole via the oral route.

Atazanavir is a novel azapeptide protease inhibitor (PI) that has been approved by FDA for use in combination with other antiretroviral agents in treatment-naïve and treatment-experienced HIV-infected individuals. Atazanavir has a low pill burden consisting of 2 capsules administered once daily and it has an adverse effect profile that is not associated with clinically relevant lipid effects. In clinical studies of up to 48 weeks, atazanavir demonstrated comparable antiretroviral efficacy to nelfinavir and efavirenz in treatment-naïve patients. The most common adverse effect associated with atazanavir is a reversible dose-related increase in unconjugated (indirect) bilirubin.

This activity has been planned and implemented in accordance with theEssential Areas and Policies of the Accreditation Council for ContinuingMedical Education (ACCME) through the joint sponsorship of the DannemillerMemorial Educational Foundation and Advanstar Communications, Inc.

State governments and enforcement agencies have become more active in efforts to regulate drug sales and marketing and have addressed a number of pressing issues:

The continuing rise of resistance rates among bacteria today has led to the need for the development of new antibiotics with the ability to circumvent current resistance mechanisms. Daptomycin (Cubicin, Cubist Pharmaceuticals) is an injectable novel lipopeptide antibiotic shown to have excellent in vitro bactericidal activity against gram-positive organisms, including resistant isolates. First in the new class of lipopeptide antibiotics, daptomycin possesses a unique mechanism of action. Daptomycin was recently approved by FDA for the treatment of complicated skin and skin structure infections caused by susceptible strains of specific gram-positive microorganisms. Daptomycin may offer an alternative in the treatment of gram-positive infections, especially when resistance is suspected.

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The continuing rise of resistance rates among bacteria today has led to the need for the development of new antibiotics with the ability to circumvent current resistance mechanisms. Daptomycin (Cubicin, Cubist Pharmaceuticals) is an injectable novel lipopeptide antibiotic shown to have excellent in vitro bactericidal activity against gram-positive organisms, including resistant isolates. First in the new class of lipopeptide antibiotics, daptomycin possesses a unique mechanism of action. Clinical studies in patients with complicated skin and skin structure infections have shown daptomycin to be similar in clinical cure rates compared to standard therapy. Daptomycin was recently approved by FDA for the treatment of complicated skin and skin structure infections caused by susceptible strains of specific gram-positive microorganisms. Daptomycin may offer an alternative in the treatment of gram-positive infections, especially when resistance is suspected.

The direct and indirect healthcare costs associated with multiple sclerosis are high. In the managed care setting, before treatment is initiated, these costs must be reconciled with other factors such as the epidemiological and clinical features of MS and current recommendations for pharmacologic management. Managed care organizations (MCOs) have the opportunity to improve the outcomes of MS through a system of care. MCOs can also manage the costs of the 2 first-line therapies (glatiramer and agents from the interferon class) used to treat MS by using stepped care and preferred formulary designations. In addition, improved outcomes can be achieved by establishing a disease management approach to treat MS.

Antihypertensive now indicated for improving survival of CHF patients

Migraine therapy available in a nasal spray formulation

First approved treatment for moderate-to-severe Alzheimer's disease

A recent "Dear Healthcare Professional" letter issued by Wyeth outlines the potential risks associated with the company's antidepressant venlafaxine (Effexor and Effexor XR) when the drug is administered in the pediatric population. The letter, dated August 22, 2003, cites data from clinical studies in pediatric patients (aged 6­17 y) and details changes that have been made to the labeling for venlafaxine. Venlafaxine has been prescribed off-label in the pediatric population despite never being approved by FDA for use in children or adolescents.

As patient-based strategies promote acceptance and wider use of generic drugs, managed care organizations' (MCOs's) tools now include aggressive voucher programs that go so far as to provide preprinted prescription blanks for patients to take to their doctors.

Benzodiazepines are the gold standard for the treatment of insomnia. However, because of their potential for pharmacologic dependence and withdrawal reactions upon discontinuation, they are neither recommended or FDA-approved for chronic use. The novel cyclopyrrolone eszopiclone (es zoe pik? lone) (Estorra, Sepracor) is a stereoselective isomer of the agent zopiclone, which has been available in Europe for more than a decade. Clinical trials in patients with chronic insomnia suggest the medication may help manage both transient and chronic insomnia with minimal side effects. The most commonly reported side effect with the agent is a bitter taste. The apparent efficacy and favorable side effect profile together with its potential for obtaining the first indication for the management of chronic insomnia in the United States make eszopiclone an attractive therapeutic option. If the drug is approved by FDA, a key issue for formulary decision-makers will be whether to make it openly available or through prior authorization for specific clinical situations. Eszopiclone?s pricing may ultimately determine its use by clinical psychiatrists and reimbursement by insurers.

One of the primary goals in today?s medical environment is to find treatments that provide positive clinical outcomes but also satisfy pressures on healthcare professionals and hospitals to deliver care as cost effectively as possible. To attain this goal, a hospital must have a pharmacy and therapeutics committee that is both scientifically and economically sound. Based on the experience of over 25 years each of the former chairman of the pharmacy and therapeutics committee (R. Quintiliani) and the director of Drug Information Services (R. Quercia) at Hartford Hospital, a large tertiary hospital in Connecticut, this article addresses ways to accomplish this goal, with particular attention given to anti-infective agents.

Indicated to reduce heterosexualtransmission of genital herpes

First antibiotic approved for CAP due to multidrug-resistant S pneumoniae

Maintenance therapy for schizophrenia

First extended-cycle oral contraceptive approved

First approval in a new class of antibiotics

Users of statins were 20% less likely to have cancer (adjusted odds ratio, 0.80; 95% CI, 0.66­0.96) in a case-control study from the Academic Medical Centre, University of Amsterdam, Netherlands, that was presented at the 39th Annual Meeting of the American Society of Clinical Oncology

Finasteride (Propecia, Merck), an inhibitor of 5a-reductase, prevents or delays the appearance of prostate cancer by 24.8% (P<.001), according to researchers from the University of Texas Health Science Center, San Antonio, Texas.