Drug Pipeline

Corticosteroid therapy is an effective treatment for asthma sufferers, but the use of systemic corticosteroids is known to increase the risk of osteoporotic fractures. A recent study published in the Journal of Allergy and Clinical Immunology suggests that moderate doses of inhaled corticosteroids (ICs) carry less risk than traditional oral corticosteroid (OC) therapy with respect to reduction of bone mineral density (BMD) in postmenopausal women. This assertion is based on the premise that the lowest daily dose of IC sufficient to control the patient's asthma is used.

Enfuvirtide (Fuzeon, Roche/Trimeris) is the first member of a unique class of antiretrovirals known as the fusion inhibitors to gain FDA approval for the treatment of human immunodeficiency virus type-1 (HIV-1) infection. Enfuvirtide is indicated for use in combination with other antiretroviral agents in the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. Phase 3 trials demonstrated that adding enfuvirtide 90 mg twice daily to an optimized background regimen chosen with genotypic and phenotypic resistance testing improved the surrogate end points of HIV ribonucleic acid (RNA) levels, CD4 cell counts, and the proportion of patients reaching clinically undetectable HIV RNA levels (<400 and <50 copies/mL) through 24 weeks. Enfuvirtide?s efficacy in treatment-experienced patients when added to an optimized background regimen makes it a promising choice for salvage therapy. Further studies will be required to support enfuvirtide?s use in treatment-naïve patients.

New Indication: SSRI approved for social anxiety disorder

Selective serotonin reuptake inhibitors (SSRIs) experienced increased usage in the 1990s due to their low toxicity and minimal adverse effects. Throughout this period, several clinical reports indicated a link between the use of SSRIs and various bleeding disorders. A recent study published in the Archives of Internal Medicine found a distinct correlation between the use of SSRIs and upper gastrointestinal (GI) tract bleeding. The population-based cohort study was conducted within the 490,000 residents of a northern Denmark county over a five-year period.

First SNRI approved for social anxiety disorder

New indications: Leukotriene blocker approved for treatment of seasonal allergic rhinitis

NME: First biologic treatment approved for psoriasis

NME: New triptan approved for acute migraine treatment

Vardenafil (Levitra, Bayer AG/GlaxoSmithKline) is a selective inhibitor of phosphodiesterase 5 (PDE5) currently under review by FDA for the treatment of erectile dysfunction (ED). If approved, vardenafil will become the third PDE5 inhibitor to be marketed in the United States and the fourth oral agent approved for the treatment of ED. Vardenafil has been studied in subjects of various ages (<45 and >65 years of age), with different etiologies and different baseline severity of ED. Studies evaluating vardenafil have determined it to be safe and effective at doses of 5 mg to 40 mg, including subjects with diabetes mellitus and subjects who have undergone radical prostatectomy. Vardenafil has a pharmacokinetic profile similar to that of sildenafil (Viagra, Pfizer). The drug appears to be well tolerated. In clinical trials, headache, dyspepsia, and flushing were the most common adverse effects reported by subjects taking vardenafil. No adverse hemodynamic or visual effects have been reported during clinical trials of vardenafil; however, further investigation, including post-marketing surveillance, will be required. Further research and clinical experience with the newer PDE5 inhibitors (vardenafil and tadalafil [Cialis, Lilly/ICOS]) will be needed before their roles in the treatment of ED can be determined.

Pulmonary arterial hypertension (PAH) is a progressive, debilitating disorder associated with poor quality of life and shortened life span. For many years, medical therapy consisted of calcium channel blockers, warfarin, supplemental oxygen, and digitalis glycosides. A better understanding of the pathophysiology of PAH has led to the recent development of effective treatments for this disorder. Therapeutic agents target the pathophysiologic mechanisms of PAH: pulmonary vasoconstriction, pulmonary vascular remodeling, and in situ thrombosis. With better understanding of the pathogenesis of PAH, recent advances in pharmacotherapy have been introduced for the treatment of PAH. Data are presented on efficacy and safety of newer approved and investigational agents: prostacyclin analogues, oral endothelin antagonists, and phosphodiesterase 5 inhibitors.

The central healthcare initiative in the administration's $2.2 trillion budget proposal for fiscal year 2004 is to establish a Medicare prescription drug benefit. President George W Bush proposes to spend $6 billion as a "down payment" on a $400 billion/10-year Medicare drug benefit and "modernization" plan.

Treatment strategies from: Vincent T. Andriole, MD, Professor of Medicine, Yale University School of Medicine Attending Physician, Yale-New Haven Hospital, New Haven, Connecticut

Antidepressant now approved for use in pediatric patients

Glaxo-SmithKline (GSK) has advised prescribers of salmeterol (Serevent) about rare, but potentially serious, respiratory adverse events in patients with asthma.

New formulation: Drug increases tear production in patients with chronic dry eye due to ocular inflammation

The recent selection of Sen Bill Frist (R-Tenn), MD, to lead Senate Republicans has moved healthcare policy up the priority list in the Senate. As a physician, Dr Frist has played a lead role in assessing federal health programs and policies.

NME: New treatment for rheumatoid arthritis

NME: New solution for home-based peritoneal dialysis

Atomoxetine, a norepinephrine reuptake inhibitor, is the first nonstimulant agent approved for the treatment of ADHD (Strattera, Lilly). It has been approved for use in pediatric and adult patients. Atomoxetine improves ADHD symptom severity versus placebo, as evaluated by the ADHD Rating Scale (ADHD RS), and its efficacy appears comparable to immediate-release methylphenidate. Atomoxetine requires dosage titration and may be administered once or twice daily. Common side effects seen in both pediatric and adult patients include nausea, decreased appetite, and dizziness. Dosage adjustments are necessary for patients receiving atomoxetine and cytochrome P450 2D6 inhibitors. Based on average wholesale price (AWP), atomoxetine is more costly than existing ADHD therapies. Atomoxetine provides an alternative ADHD therapy for patients who may fail or cannot tolerate conventional treatments.

Intraabdominal infection was first thoroughly described by Hippocrates. Centuries later, despite advances in surgical and supportive therapies, this disease state continues to be associated with significant morbidity and mortality. This article reviews the literature on intraabdominal infections. It describes the pathophysiology, classification, and etiology of intraabdominal infections, focusing primarily on secondary peritonitis. The bacteriology of the gastrointestinal tract in both the normal and infected host is reviewed. Treatment options, including newly approved antimicrobial agents and agents under clinical investigation, are reviewed.

Direct-to-consumer (DTC) advertising is boosting prescription use, pharmaceutical companies are spending more on DTC ads, and FDA needs to act more quickly to remove false or misleading commercials from the air.

Ann Arbor, Mich-Atorvastatin, especially at higher dosages, may prevent activation of the antiplatelet agent clopidogrel, according to research at the University of Michigan, Ann Arbor.

The American Academy of Family Physicians and the American College of Physicians­American Society of Internal Medicine, with assistance from the American Headache Society, released the migraine treatment guidelines. Migraine headaches affect 18% of women and 6.5% of men in the United States and are a major cause of absenteeism and reduced productivity.

Washington, DC-Representatives from the American Society of Health-SystemPharmacists and the American Medical Association met with the Health andHuman Services assistant secretary for health Eve Slater, MD, and FDA'sdeputy commissioner Lester Crawford, DVM, PhD, in late January to discussdrug shortages and ask for federal assistance in resolving the problem.

As of July 1, 2002

J Russell Teagarden, MA, RPh, vice president of clinical practices and therapeutics at Medco Health Solutions in Franklin Lakes, NJ, explains how using an ?ethical template? for pharmacy benefit decisions can make those decisions consistent and fair, reducing patient displeasure, conflict, and litigation.

Psychostimulant drugs have consistently demonstrated efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD). Innovative technology has fueled the development of novel release mechanisms and isolation of active enantiomer components with the hopes of enhancing the duration of action and improving the safety and effectiveness. As a result, several new stimulant agents have recently been added to the arsenal of ADHD treatment options. Formulary selection is complicated by the high costs and small but distinct differences among these agents. The five newest FDA-approved stimulant agents for the treatment of ADHD are detailed, and a brief summary of future treatment options, including a recently approved nonstimulant agent, is provided.

If asked, could you present the underlying rationale for your pharmacy benefit coverage decisions? When considered from the consumer or employee perspective, why should they consider the payors or providers of their drug benefit legitimate decision-makers in limiting their healthcare policies?

Duloxetine is a reuptake inhibitor at serotonergic and noradrenergic neurons and appears to have low affinity for other neurotransmitter systems. In three published clinical trials in patients with MDD, duloxetine was well tolerated and more effective than placebo. Further study is needed to compare its efficacy with that of other antidepressants, to prospectively assess time to onset of antidepressant effect, and to clarify effects on somatic symptoms and potential adverse cardiovascular and sexual effects. Duloxetine is also under investigation for the treatment of stress urinary incontinence in women (trade name to be determined, comarketed by Lilly and Boehringer Ingelheim). Preliminary information suggests that duloxetine therapy reduces the number of incontinence episodes. Duloxetine has been deemed ?approvable? for the treatment of MDD and will be comarketed under the trade name Cymbalta by Eli Lilly and Company and Quintiles.

Cholesterol-lowering drug represents new class