Formulary Watch |

Recent FDA approvals

Desmopressin tablets 0.1 and 0.2 mg (equiv to DDAVP tablets).

Actoplus Met

Pioglitazone acts primarily by decreasing insulin resistance, while metformin improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose.

FDA actions in brief

Valsartan (Diovan, Novartis) received an expanded indication for reducing cardiovascular mortality in patients who are at high risk due to left ventricular failure or dysfunction after myocardial infarction.

Celebrex

This NSAID is believed to exert its therapeutic effect through inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2). Celecoxib was approved on July 29, 2005, for the relief of the signs and symptoms of ankylosing spondylitis (AS).

Dual peroxisome proliferator-activated receptor agonist demonstrates significant lipid benefits

Phase 3 clinical trial results have demonstrated that the dual alpha/gamma peroxisome proliferator-activated receptor (PPAR) agonist muraglitazar achieves significant beneficial lipid effects compared with pioglitazone, and the agent also provides long-term glycemic control in type 2 diabetics. The results were reported during the American Diabetes Association (ADA) 65th Annual Meeting in San Diego, Calif.

Drug Watch: Antipsychotic agents in late-stage development (August 2005) (PDF)

A review of antipsychotic agents in late-stage development (August 2005).

Non-elderly patients with overactive bladder have significant comorbidities

A study was conducted to evaluate the clinical and economic burden of overactive bladder (OAB) among patients <60 years of age in a managed care population, especially with regard to the prevalence of related comorbidities and associated annual medical costs.

Adalimumab demonstrates efficacy in Crohn's disease

The human monoclonal antibody adalimumab induces significant Crohn's disease remission compared with placebo, according to trial results presented during Digestive Disease Week (DDW) in Chicago, Ill. Adalimumab is approved for the treatment of rheumatoid arthritis.

Dual peroxisome proliferator-activated receptor agonist demonstrates significant lipid benefits

Phase 3 clinical trial results have demonstrated that the dual alpha/gamma peroxisome proliferator-activated receptor (PPAR) agonist muraglitazar achieves significant beneficial lipid effects compared with pioglitazone, and the agent also provides long-term glycemic control in type 2 diabetics. The results were reported during the American Diabetes Association (ADA) 65th Annual Meeting in San Diego, Calif.

The levothyroxine spectrum: Bioequivalence and cost considerations

Levothyroxine, a critical medication for millions of Americans, has had a long and turbulent history. In the face of tougher FDA regulations and especially its reclassification as a "new drug" in 1997, manufacturers have struggled to carve out their niche in an expansive market. The principal concern of physicians, patients, endocrinologists, manufacturers, and FDA is levothyroxine's relative bioequivalence. Even after FDA classified several products as bioequivalent, a single brand name product still holds most of the market share, despite the fact that it is more costly. Current issues surrounding levothyroxine include: controversy about research, the number and types of recalls, the lack of a single reference-listed drug for comparison, and conflicting claims about the bioequivalence of various formulations. (Formulary. 2005;40:258–271.)

Crawford seeks to restore confidence in FDA approval process

After months of delay, the Senate confirmed Lester M. Crawford, DVM, PhD, in July as the official head of FDA. Despite efforts by some Senators to hold up the vote pending resolution of some FDA policies, most legislators agreed with Republican and Democratic leaders that the agency would be better off with a permanent chief than without.

Tigecycline: A novel glycylcycline antiobiotic

Highly resistant strains of both gram-positive and gram-negative bacteria are becoming commonplace in both the inpatient and outpatient setting. Recently developed antimicrobials have targeted resistant gram-positive pathogens, but the problem of resistant gram-negative pathogens remains. Tigecycline (Tygacil, Wyeth) is an injectable antimicrobial and the first in a new class of agents (the glycylcyclines) that possesses activity against key gram-positive and gram-negative bacterial pathogens. Tigecycline overcomes common tetracycline resistance mechanisms and has shown in vitro and in vivo activity against multidrug-resistant organisms. Tigecycline treatment produced clinical and microbiologic outcomes similar to standard comparator agents in patients with complicated skin and skin structure infections and complicated intra-abdominal infections and was approved for these indications in June 2005. The most common adverse events associated with tigecycline's administration during clinical trials were..

FDA actions in brief

FDA approved moxifloxacin (Avelox, Schering-Plough) tablets and injection for the once-daily treatment of adults with complicated skin and skin structure infections (cSSSIs) caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.

Rozerem

Efficacy. The efficacy of ramelteon in the treatment of chronic insomnia was evaluated in 2 randomized, double-blind trials employing polysomnography (PSG).

Pipeline Preview

Alvimopan (Entereg, Adolor/GlaxoSmithKline) for the treatment of postoperative ileus.

Drug Watch: Agents in late-stage development for the treatment of selected genitourinary disorders (July 2005) (PDF)

A review of agents in late-stage development for the treatment of selected genitourinary disorders (July 2005).

NSAID utilization patterns following market withdrawal of rofecoxib

Cyclooxygenase-2 (COX-2)-selective nonsteroidal anti-inflammatory drugs (NSAIDs) have been widely prescribed for patients with arthritis and other conditions because of their lower risk for gastrointestinal adverse events compared with nonselective NSAIDs 1,2

Dapoxetine: A novel, fast-acting serotonin reuptake inhibitor

Dapoxetine (Alza/Ortho-McNeil) is a novel oral medication undergoing FDA review for premature ejaculation, one of the most common disorders of sexual dysfunction in men. Dapoxetine is a fast-acting inhibitor of the serotonin reuptake transporter. It has a short half-life and is structurally related to the antidepressant fluoxetine, allowing for on-demand dosing.

Calcium antagonist/statin combination improves artery elasticity

Small artery elasticity improves more with coadministration of amlodipine and atorvastatin compared with either treatment alone, said Jay N. Cohn, MD, at the 20th annual meeting of the American Society of Hypertension (ASH) in San Francisco. The additive effect of amlodipine and atorvastatin on small artery compliance may explain the superior clinical cardiovascular outcomes associated with the combination versus monotherapy with either drug.

Sirolimus maintenance regimen improves graft survival in kidney transplant recipients

Kidney transplant recipients on an immunosuppressive regimen of sirolimus plus cyclosporine who had their cyclosporine withdrawn at an early stage had significantly better graft survival than patients who remained on cyclosporine. The advantage appeared to be related to significantly improved kidney function in the patients in whom cyclosporine was withdrawn, reported Graeme Russ, MD, at the American Transplant Congress 2005 in Seattle, Wash.

Cost analysis of combination vs single dosage lipid-lowering

A study was conducted to determine the cost and patient adher- ence rates of lipid-lowering therapy with an extended-release niacin and lovastatin (ERNL) combination agent versus a separate extended-release niacin and statin (ERN-S) combination or statin monotherapy.

Trends in utilization of alternative analgesics after rofecoxib withdrawal

The objective of this study was to track the utilization of anti-inflammatory drugs among patients with active rofecoxib prescriptions at the time of market withdrawal through retrospective analysis of pharmacy records and to assess the need for COX-2 inhibitor therapy due to gastrointestinal risk factors.

Formulary Decision-makers update P&T policies following COX-2 inhibitors

Following the voluntary withdrawal of rofecoxib in September 2004 and the subsequent FDA-requested withdrawal of valdecoxib in April 2005, formulary decision-makers are considering options in navigating the changing pain management landscape. With one remaining COX-2 inhibitor available on the market (celecoxib [Celebrex, Pfizer]) and more cardiovascular (CV) risk data available for the class, the efficacy, adverse events, risk/benefit profiles, and costs of both COX-2-selective and nonselective NSAIDs are receiving more attention than ever.

FDA actions in brief

Pregabalin (Lyrica, Pfizer) was granted an expanded indication to include the adjunctive treatment of partial onset seizures in adults with epilepsy.

Aptivus

Accelerated approval granted for protease inhibitor

Byetta

First-in-class approved for type 2 diabetes

First-time generic approval

Mometasone topical solution 0.1% (equiv to Elocon topicallotion)

Tygacil

Broad spectrum antibiotic approved for cSSSIs and cIAIs

Drug Watch: Agents in late-stage development for the treatment of gastrointestinal disorders (June 2005) (PDF)

A review of agents in late-stage development for the treatment of gastrointestinal disorders (June 2005).

Alvimopan: A peripherally selective opioid mu receptor antagonist

Post-operative ileus causes significant patient morbidity and is a major contributor to patient discomfort and increased length of hospitalization post-operatively. Alvimopan (Entereg, Adolor/GlaxoSmithKline), a peripherally selective opioid mu receptor antagonist with gastrointestinal (GI) tract-specific activity, is undergoing FDA review for the treatment of post-operative ileus.