Drug Pipeline

Briefs of FDA actions/approvals of drugs, doses, and indications

Pediatric exclusivity program and generic biotech therapies as related to PDUFA IV.

Results of a study conducted to determine whether users of nonformulary blood glucose meters would increase their formulary compliance if they were provided with targeted information and an offer for a free formulary meter.

A summary of several automated IV and syringe preparation systems and a discussion of the technology's impact on pharmacy efficiency.

Patients with silent ischemia but no coronary artery disease (CAD) may benefit from treatment with antianginal drug therapy, according to results of The Swiss Interventional Study on Silent Ischemia Type I (SWISS II)

Nicotine patches used for smoking cessation are safe in patients with coronary artery disease (CAD) and active stress-induced myocardial ischemia, according to the results of a randomized trial.

An 80-mg dose of atorvastatin administered 12 hours before angioplasty, followed by a 40-mg dose administered 2 hours before the procedure significantly reduces the risk of major cardiovascular events during the month after the intervention, according to the results of The Atorvastatin for Reduction of Myocardial Damage during Angioplasty-Acute Coronary Syndromes (ARMYDA-ACS) trial.

Results of FUSION II, a randomized, double-blind, placebo-controlled study involving 920 patients with stage D chronic decompensated HF, presented at the 56th Annual Scientific Session of the ACC.

New research presented at the AAD's 65th Annual Meeting regarding treatment of biologic psoriasis with adalimumab and efalizumab.

A meta-analysis of randomized controlled trials demonstrated that anticoagulant prophylaxis of hospitalized patients statistically significantly reduced their risk of developing both a pulmonary embolism (PE) and deep vein thrombosis (DVT).

Intensive statin therapy in elderly patients may be more effective than moderate statin therapy in improving lipid levels and reducing all-cause death, according to a prospective, international, multicenter, randomized, double-blind, double-dummy, parallel-arm trial in elderly patients with documented coronary artery disease (CAD).

Patients with osteoarthritis or rheumatoid arthritis who are taking etoricoxib may experience significantly fewer upper gastrointestinal (GI) events compared with those taking diclofenac, according to the pooled results of 3 randomized trials.

Sorafenib significantly improves progression-free survival in patients with advanced clear-cell renal-cell carcinoma, according to results from a phase 3, randomized, double-blind, placebo-controlled trial.

In a systematic review and meta-analysis, the use of beta-carotene, vitamin A, and vitamin E, either alone or combined, was associated with an increased risk of all-cause mortality.

Prospective treatment with rosuvastatin can slow the hemodynamic progression of asymptomatic aortic stenosis. This was the conclusion of the prospective, open-label Rosuvastatin Affecting Aortic Valve Endothelium (RAAVE) trial.

In a randomized, double-blind, parallel-group trial, triple therapy with tiotropium plus salmeterol (SAL) and fluticasone failed to reduce the proportion of patients with chronic obstructive pulmonary disease (COPD) experiencing exacerbations requiring treatment with systemic corticosteroids and/or antibiotics (the primary end point) compared with tiotropium plus salmeterol or tiotropium alone.

The combination of aspirin (ASA) and oral anticoagulation (OAC) significantly reduces the odds of thromboembolism, but has no effect on all-cause mortality versus OAC alone, according to a systematic review and meta-analysis.

A post-hoc analysis invloving 4 prospective, randomized trials demonstrated that treatment of CAD with statins increases HDL-C, and the increases correlate with a positive impact on disease progression.

A phase 3 study evaluating the use of gabapentin alone and in combination with an antidepressant in women with hot flashes who had an inadequate response with antidepressant monotherapy demonstrated that gabapentin reduced hot flashes by approximately 50%, whereas the combination of an anti-depressant with gabapentin appeared to offer no additional benefit.

Patients who fail to adhere to warfarin therapy as prescribed are more likely to experience problems with anticoagulation control, according to the authors of the International Normalized Ratio Adherence and Genetics (IN-RANGE) study.

Alteplase demonstrated to be safe and effacious for use in treatment of stroke within 3 hours of onset, according to a large multicenter, observational study.

Treament of hypertension with a polypill is more effacious than single-drug treatment, according to a randomized, controlled, open-label trial.

Results of a double-blind, randomized, contolled trial of vildagliptin versus rosiglitazone demonstrate similar efficacy and tolerability in patients with type 2 diabetes.

Pulmonary arterial hypertension (PAH) is a disease state characterized by vascular narrowing and increased pulmonary vascular resistance. Physical symptoms, which may include fatigue or weakness, exertional dyspnea, and peripheral edema, are often nonspecific and can mimic more common disorders encountered in clinical practice. Healthcare professionals have been limited in which medications could be used to treat this condition because clinical data have been scarce. Recently, multiple new classes of medications, many of which are very costly, have become available; these agents offer physicians more therapeutic options for the treatment of PAH. Managed-care organizations have been challenged with suggesting the appropriate place in therapy for these new agents, as well as ensuring their safe and cost-effective utilization. This review summarizes the data available for the drugs used to treat PAH, with the goal of helping organizations to make appropriate decisions regarding the proper use of these agents.

Briefs of FDA actions related to medication safety and reliability (ie, boxed warnings, dear healthcare provider letters)

A large retrospective cohort study demonstrated an increased risk of suicide with use of the antidepressant venlafaxine.

In a large, population-based, case-control study, rofecoxib and celecoxib were associated with an excess risk of acute myocardial infarction (MI) in patients with a history of MI.

First-time generic drug approvals: Nadolol/bendroflumethiazide and ciprofloxacin

The latest FDA action (through May 2007) related to armodafinil (Nuvigil), tacrolimus (Prograf), sipuleucel-T (Provenge), Etoricoxib (Arcoxia), AZD-103/ELND005 (Transition), rNAPc2, Satraplatin, and Ganciclovir

Levetiracetam (Keppra) is now approved by FDA as an antiepileptic agent for adjunctive therapy in treatment of primary generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy.