Formulary Watch |

FDA releases proposals for PDUFA IV; federal report addresses cost of drug development

A public forum scheduled this month will help to solidify proposals FDA unveiled in January for reauthorization of the Prescription Drug User Fee Act (PDUFA). Once public comment from the February 16 meeting is received and incorporated into the finalized proposal, negotiations between the agency and the federal government over the fourth incarnation of this important funding mechanism will be key in determining FDA's fiduciary future.

New diagnostic tool aids in pathogen identification; kiosks in doctors' offices provide generic drug samples

Researchers at the Infectious Disease Laboratory at Columbia University Mailman School of Public Health and the World Health Organization (WHO) Global Laboratory Network have developed a new diagnostic tool called the "GreeneChip," a glass slide that can rapidly and accurately identify multiple pathogens from different biologic samples (eg, tissue, blood, urine).

A critical look at prescription drug direct-to-consumer advertising

Direct-to-consumer advertising (DTCA) of prescription drugs has been a source of debate since its US approval by FDA in 1997. A primary source of debate among experts is the methods advertisers use to attempt to influence the consumer and the consumer's subsequent reaction. Despite the controversy, authors of a recent content analysis of televised DTCA say there has been no systematic analysis of DTCA's influence on consumers to date.

AGA issues consensus statement on the use of NSAIDs

The American Gastroenterological Association (AGA) has issued a consensus statement on the safe and efficacious use of nonsteroidal anti-inflammatory drugs (NSAIDs), including nonselective, nonsteroidal anti-inflammatory drugs (nsNSAIDs), cyclooxygenase-2 enzyme inhibitors (coxibs), and aspirin (ASA).

Sleep disturbance associated with SSRI use in older women

A cross-sectional study of selective serotonin reuptake inhibitor (SSRI) use by community-dwelling older women aged ≥71 years with or without depression demonstrated that SSRI use in that population was strongly associated with sleep disturbance. The study, which relied on data collected from 4 centers throughout the United States, was recently published in the Journal of the American Geriatrics Society.

Antipsychotics demonstrate minimal benefit in treatment of psychosis, aggression, agitation in patients with AD

Adverse events associated with the use of atypical antipsychotic medications in the management of psychosis, aggression, and agitation in patients with Alzheimer's disease (AD) may outweigh any benefit the treatments provide, according to a double-blind, placebo-controlled study published in the New England Journal of Medicine (NEJM).

Rifaximin considered as possible treatment for IBS

Rifaximin has demonstrated global improvement of the symptoms of irritable bowel syndrome (IBS) in patients for ≤10 weeks after the discontinuation of therapy. Rifaximin is a nonabsorbed (≤0.4%), broad-spectrum antibiotic that was approved by FDA in 2004 for travelers' diarrhea.

Aspirin may reduce the risk of newly diagnosed adult-onset asthma

A post-hoc analysis of the large, randomized, double-blind, placebo-controlled Physicians' Health Study found that the use of low-dose aspirin (ASA) on alternating days reduced the risk of adult-onset asthma by a statistically significant 22%.

FIT versus FLEX: Weighing the benefits of extending bisphosphonate therapy beyond 5 years

A randomized, double-blind, placebo-controlled trial published in the Journal of the American Medical Association (JAMA) found that women who discontinued alendronate after 5 years demonstrated a moderate decline in bone mineral density (BMD) and a gradual increase in serum markers of bone turnover compared with women who continued taking alendronate for an additional 5 years, but mean levels among patients who discontinued therapy remained at or above baseline levels measured 10 years earlier. In addition, no greater fracture risk other than for clinically detected vertebral fractures was seen in the discontinuation group compared with patients who continued alendronate for 10 years.

Extended dual antiplatelet therapy demonstrated to improve post-DES implantation outcome

The duration of dual antiplatelet therapy (aspirin plus clopidogrel) following drug-eluting stent (DES) implantation has been a source of much recent debate. FDA currently recommends either 3 or 6 months of clopidogrel therapy following DES implantation, depending on the type of stent used.

Long-term use of acid-suppressing drugs may be associated with increased risk of hip fracture

In a large, nested case-control study published in the Journal of the American Medical Association (JAMA), proton pump inhibitor (PPI) use was demonstrated to be associated with a 44% to 165% increase in the risk of hip fracture in patients aged >50 years.

Cabergoline, pergolide linked to cardiac-valve regurgitation

Concern over possible valvulopathy with the use of certain ergot-derived dopamine agonists is further supported by 2 studies published in The New England Journal of Medicine (NEJM) regarding the incidence of cardiac-valve regurgitation in patients taking these types of drugs, which are FDA-approved to treat Parkinson disease and hyperprolactinemia and sometimes used off-label to treat restless legs syndrome.

FDA actions in brief

An estradiol transdermal gel (Elestrin [formerly Bio-E-Gel], Bradley/BioSante) was approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.

First-time generic approvals

Methscopolamine tablets, 2.5 mg (equiv to Pamine tablets)

Pipeline Preview

Approvable designations; Nonapprovable designation; Fast-track designation; Priority review; Orphan drug designations

Aripiprazole injection for intramuscular use

Intramuscular injectable formulation of atypical antipsychotic approved for the treatment of agitation associated with schizophrenia or bipolar disorder, manic or mixed

Exenatide injection

Incretin mimetic approved as adjunctive therapy in type 2 diabetes mellitus not adequately controlled by a thiazolidinedione

Ertapenem for injection

Antibiotic approved for the prophylaxis of surgical site infection following elective colorectal surgery

Drug Watch: Agents in late-stage development for the treatment of hepatitis (February 2007) (PDF)

A review of agents in late-stage development for the treatment of hepatitis (February 2007)

Arformoterol: The first nebulized long-acting beta2-adrenergic agonist

Bronchodilators play an important role in the management of stable chronic obstructive pulmonary disease (COPD). Although bronchodilators do not prevent the decline in lung function in patients with COPD, their efficacy in improving disease-related symptoms, reducing the frequency and severity of disease exacerbations, and improving patients' quality of life has been demonstrated in clinical trials. Arformoterol, the (R,R)-enantiomer of the selective beta2-agonist formoterol, is a potent, highly specific, nebulized long-acting beta2-adrenergic agonist recently approved by FDA for the long-term maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. In 2 large, 12-week, phase 3 studies, arformoterol demonstrated an efficacy superior to that of placebo and comparable to that of salmeterol in patients with COPD. In these trials, arformoterol was well tolerated, with a safety profile similar to that of other inhaled long-acting beta2-agonists when used at..

Drug Watch: Agents in late-stage development for arrhythmia and heart failure (January 2007) (PDF)

A review of agents in late-stage development for the treatment of arrhythmia and heart failure (January 2007).

The impact of antipsychotic agent choice on the risk of coronary heart disease mortality due to cholesterol effects

Schizophrenia is a chronic disease usually diagnosed when patients are in their mid- to late 20s; therefore, patients may receive decades of exposure to antipsychotic agents over their lifetime. Whenever long-term pharmacotherapy is required for a disease, the cardiovascular implications of that therapy need to be considered. This fact was recently highlighted by the removal of the cyclo-oxygenase-2 inhibitors rofecoxib and valdecoxib from the US market because of marked elevations in cardiovascular risk.

Von Eschenbach sworn in as FDA commissioner; 2007 may be year of reform at agency

In an 80-to-11 vote in December 2006, the US Senate confirmed Andrew von Eschenbach, MD, as commissioner of FDA. The nomination process included multiple holds by members of both political parties, which delayed his confirmation.

Personal health records go portable; hospitals tap into translation services by video

Five of the nation's largest employers plan to offer employees access to their own portable electronically based medical records that they can use when they travel, see a new doctor, or change jobs to retain information about their healthcare, including medications.

FDA advisory panel weighs safety of drug-eluting stents

When used for their approved indications, drug-eluting stents (DES) probably do not increase the risk of death or myocardial infarction (MI) compared with bare metal stents (BMS), an FDA advisory panel concluded at a meeting in Gaithersburg, Md, last month.

A review of the pharmacologic options for the treatment of alcohol dependence

The chronic and excessive use of alcohol adversely affects the healthcare system, work productivity, and familial and social relationships. Alcohol misuse accounts for 85,000 deaths per year in the United States, and the overall financial costs related to alcohol dependence are more than $100 billion annually. The reduction of alcohol misuse can be measured as an increase in the frequency of abstinence or a reduction in the frequency of relapses. The recommendation for alcohol dependence treatment is a combination of psychosocial support therapy and pharmacologic treatment. Currently, there are only 3 FDA-approved agents for the treatment of alcohol dependence: naltrexone, acamprosate, and disulfiram.

Study observes increased risk for CV events in men with migraines

Men who suffer from migraines are at increased risk for cardiovascular (CV) events, according to new data from the Physicians' Health Study. These observations follow similar reports that women with symptoms associated with migraines are at higher risk for CV disease.

Rifaximin may prevent multiple recurrences of CDAD

Data indicate that oral rifaximin can prevent recurrences of Clostridium difficile-associated diarrhea (CDAD) in patients treated previously with vancomycin, said presenters at the American College of Gastroenterology Annual Scientific Meeting (ACG) in Las Vegas, Nev.

Once-daily formulation of mesalamine induces, maintains remission in patients with ulcerative colitis

A once-daily formulation of mesalamine that relies on multimatrix (MMX) technology is effective at inducing and maintaining remission in patients with ulcerative colitis (UC), with no significant gender difference in the response rate, according to studies presented at Digestive Disease Week (DDW) 2006 in Los Angeles, Calif, and at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nev.

Crohn's disease: certolizumab, adalimumab demonstrate efficacy in prior users of infliximab

Certolizumab and adalimumab demonstrated efficacy in inducing and maintaining response in patients with Crohn's disease who have lost response or are intolerant to infliximab, reported researchers at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nev.