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.
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.)
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.
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 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.
Efficacy. The efficacy of ramelteon in the treatment of chronic insomnia was evaluated in 2 randomized, double-blind trials employing polysomnography (PSG).
Alvimopan (Entereg, Adolor/GlaxoSmithKline) for the treatment of postoperative ileus.
A review of agents in late-stage development for the treatment of selected genitourinary disorders (July 2005).
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 (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.
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.
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.
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.
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.
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.
Pregabalin (Lyrica, Pfizer) was granted an expanded indication to include the adjunctive treatment of partial onset seizures in adults with epilepsy.
Accelerated approval granted for protease inhibitor
First-in-class approved for type 2 diabetes
Mometasone topical solution 0.1% (equiv to Elocon topicallotion)
Broad spectrum antibiotic approved for cSSSIs and cIAIs
A review of agents in late-stage development for the treatment of gastrointestinal disorders (June 2005).
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.
Psoriasis is a chronic, inflammatory dermatologic disease that can have a significant physical and psychological impact on affected patients.
The new independent Drug Safety Oversight Board (DSB) within CDER will employ a two-pronged approach to create "a new culture of openness, improved oversight, and enhanced independence," according to FDA officials.
A review of agents in late-stage development for the treatment of hepatitis (May 2005).
New regulations proposed by the California state Department of Managed Health Care (DMHC) that are expected to be implemented by the end of this year would require HMOs in California to cover all medically necessary prescription drugs, even if they are excluded from a plan's formulary.
