Drug Pipeline

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

Chronic hepatitis C therapy for patients with compensated liver disease

With the threat of bioterrorism, there was a need to reintroduce a smallpox vaccine. FDA has now approved this dried, calf lymph-type vaccine.

GOP control of both the Senate and House has pushed efforts to establish a Medicare drug benefit to the top of the legislative agenda. It also has moved proposals to reimport pharmaceuticals from Canada or Mexico and reform generic drug policy down the priority list.

It's been a year and a half since Humana, Inc, made the move to a four-tier benefit design. Humana's rationale for evolving to the four-tier model, the technology and programs developed to support this benefit structure, and the initial success were discussed by James Stines, director of pharmacy sales for Humana.

Successful management of migraine attacks and their symptoms leads to economic benefits such as decreased reliance on healthcare resources, decreased employee absenteeism, and increased productivity. Appropriate treatment includes prophylaxis with lifestyle changes and drug therapy, and acute therapy with drugs. Over-the-counter analgesics can be effective acute therapy for mild migraine; for moderate to severe attacks, the 5HT1B/1D agonists, or triptans, offer significant efficacy and cost-effectiveness.

Ezetimibe (Zetia), approved in late October, represents the first new class of cholesterol-lowering drugs in 15 years. Ezetimibe, an intestinal cholesterol absorption inhibitor, has a unique mechanism of action, distinct from those of statins and bile acid sequestrants. When used as monotherapy, ezetimibe lowers low-density lipoprotein cholesterol (LDL-C) levels up to 18.5%. Coadministration of ezetimibe with statin therapy reduces LDL-C levels up to an additional 22%. The article reviews ezetimibe?s chemistry, pharmacology, pharmacokinetics, and clinical trial results.

Microbial resistance is a concern in treating urinary tract infection (UTI) and bacteremia. But analysis of data from more than 200 US hospitals in the Surveillance Network Database-USA from 1999 to 2001 demonstrated bloodstream and urinary tract isolates with the potential to cause urosepsis to be very susceptible in vitro to broad-spectrum b-lactams and aminoglycosides. The study results were reported at the 42nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego, CA.

Patients with mild chronic heart failure who are treated early on with the beta blocker carvedilol (Coreg) along with the angiotensin-converting enzyme (ACE) inhibitor enalapril demonstrated a significantly greater improvement in left ventricular remodeling than patients receiving either drug alone, according to a 572-patient study presented at the European Society of Cardiology (ESC) Congress in September in Berlin. The results reinforce current treatment recommendations.

Studies presented at the Third European Stanley Foundation Conference on Bipolar Disorder in September in Freiburg, Germany, show two newer antipsychotics are each more effective than standard therapy for preventing mania relapse or reducing symptoms.

NME: Aldosterone blocker approved to treat hypertension

Although a New York court ruled last month that the generic manufacturer KUDCO did not infringe on two AstraZeneca patents relating to the formulation of the antiulcer drug omeprazole (Prilosec), KUDCO cannot move forward because Andrx and Genpharm hold 180-day exclusive marketing rights for various strengths. The court also ruled that Andrx and Genpharm, as well as Cheminor, did infringe on the patents--so the path is not yet clear for generic omeprazole.

A phase III study presented at the 14th annual meeting of the Migraine Trust International Research Symposium (MTIRS) in September in London showed that topiramate (Topamax) significantly reduced migraine frequency at doses as low as 100 mg/d. The onset of efficacy was observed as early as the first month of treatment. Topiramate is already approved in the United States and worldwide as an

NME: Antiviral approved to treat hepaptitis B

Aripiprazole is an investigational atypical antipsychotic that received an approvable status from FDA in September 2002 for the treatment of schizophrenia. The decision on approval could be made as early as the end of this year. Aripiprazole offers a unique mechanism of action as a dopamine system stabilizer. Aripiprazole has been found to be effective in both short-term (4?6 wk) and long-term (26?52 wk) treatment trials. It appears to produce less hyperprolactinemia, weight gain, and extrapyramidal symptoms than other antipsychotics.

Although the commonly used HMG CoA reductase inhibitors (statins) are well tolerated and relatively safe, muscle toxicity and rhabdomyolysis can occur with administration and can be severe. This risk is higher with more bioavailable and lipophilic statins. This article summarizes what is known about the etiology of statin-associated muscle toxicity, the risks for each statin, and the current recommendations for monitoring and management.

After months of speculation, in late September the White House finally nominated its lead health policy advisor, Mark B. McClellan, MD, PhD, as the next commissioner of the FDA.

A recent study confirms that multi-tier formularies with higher copays for certain drug categories reduce overall spending on prescription drugs by beneficiaries in employer health plans.

Formulary has identified three organizations that recently begancharging pharmaceutical representatives a fee to meet withphysicians. Two of the organizations-Queen City Physicians and thePolyclinic-are physician group practices based in Cincinnati, OH,and Seattle, WA, respectively.

Agency plans to consolidate oversight of drugs and biologics and revise program for ensuring high quality pharmaceutical manufacturing

Applied Health Outcomes, Tampa, FL-Fixed-dose combination antihypertensive agents may save money for your institution or plan as well as for your patients.

Eplerenone is a selective aldosterone receptor antagonist under FDA review for treatment of hypertension. With a high trough-to-peak ratio, it is suitable for once-daily dosing. It significantly reduces blood pressure in patients with mild to severe hypertension and can be used alone or in combination with other antihypertensives. Although chemically related to spironolactone, eplerenone has a lower binding affinity for androgenic and progestogenic receptors than spironolactone, which may translate into a lower incidence of endocrine-related adverse effects. In addition, eplerenone lowers blood pressure particularly well in patients with low-renin, salt-sensitive hypertension, such as African Americans.

Sometimes regarded with suspicion, evidence-based medicine is not just a ploy to reduce costs. Rather, it is the best approach to decision-making in modern medical practice. This internationally recognized authority on evidence-based medicine explains what it is, how to use it to make the best clinical decisions, and how to implement it in practice. Sometimes regarded with suspicion, evidence-based medicine is not just a ploy to reduce costs. Rather, it is the best approach to decision-making in modern medical practice. This internationally recognized authority on evidence-based medicine explains what it is, how to use it to make the best clinical decisions, and how to implement it in practice.

MME:Second IBS drug approved, this time for constipation predominant illness