Drug Pipeline

Initial combination therapy for early rheumatoid arthritis (RA) provides earlier clinical improvement and less progression of joint damage at 2 years compared with initial monotherapy, according to a randomized, controlled trial.

Results of a systematic review demonstrated that high doses of aspirin for >10 years may help reduce the incidence of colonic adenoma and colorectal cancer.

Men who use acetaminophen, nonsteroidal anti-inflammatory drugs(NSAIDs), or aspirin are at an increased risk of developing hypertension, compared with nonusers, according to a large, retrospective, case-controlled study.

FDA has approved a new formulation for zolpidem, a nonbenzodiazepine hypnotic, for short-term treatment of insomnia.

FDA has approved a new formulation for zolpidem, a nonbenzodiazepine hypnotic, for short-term treatment of insomnia.

The Prescription Drug User Fee Act (PDUFA) expires in September, therefore FDA may need to warn drug reviewers that their jobs may be eliminated if Congress does not honor the reauthorization deadline.

Insurers, payors, and health policy experts are seeking additional evidence that compares the safety, efficacy, and cost of medical products and procedures.

An oral thrombin receptor antagonist demonstrated no increase in major or minor bleeding when added to standard antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI), according to phase 2 trial results.

In a phase 3 trial, the investigational dihydropyridine calcium antagonist clevidipine demonstrated less pronounced perioperative blood pressure excursions compared with other intravenous antihypertensive agents in patients undergoing cardiac surgery.

Patients with pain related to fibromyalgia syndrome (FMS) can experience a 50% reduction in pain if they are treated with pregabalin, according to results presented at the AAN's 59th annual meeting.

New research presented at the AAN's 59th annual meeting regarding strategies for treatment of relapsing remitting multiple sclerosis.

A single dose of ibuprofen provides better pain relief than acetaminophen or codeine for children requiring emergency treatment for musculoskeletal trauma, results of a randomized, controlled trial demonstrate.

Statins may reduce risk of hospitalization for sepsis in patients with chronic kidney disease (CKD) who are receiving dialysis, according to a large cohort study.

When used to treat patients with ulcer bleeding, proton-pump inhibitors (PPIs) effectively reduce the risk of re-bleeding and the need for surgical intervention and repeated endoscopic treatment, according to a meta-analysis.

In a large, nested cohort study, use of inhaled corticosteroids at doses greater than 1,200 mcg/d was associated with a 61% reduction in the risk of developing lung cancer in patients with chronic obstructive pulmonary disease.

Nausea and vomiting (emesis) are among the most distressing side effects of chemotherapy and are associated with significant clinical consequences. Four distinct types of chemotherapy-induced nausea and vomiting (CINV) have been described: acute, delayed, anticipatory, and breakthrough. Clinical practice guidelines provide specific recommendations for controlling the different types of CINV depending on the emetogenic potential of the chemotherapy regimen being used. Three classes of antiemetics are considered potent and well-tolerated options: 5-HT3 serotonin-receptor antagonists, corticosteroids, and neurokinin-1-receptor antagonists. Phenothiazines, butyrophenones, cannabinoids, metoclopramide, and benzodiazepines are also sometimes used to prevent CINV caused by minimally emetogenic chemotherapy or to treat breakthrough CINV. This article reviews the currently available antiemetic agents and clinical practice guidelines for the management of CINV.

Schizophrenia is a chronic psychiatric disorder that affects an estimated 1% of the population. This disorder may be treated with typical (first-generation) or atypical (second-generation) agents; a recognized concern regarding these agents is that long-term use has been associated with increased risks of serious side effects, either neurologic or metabolic in nature. Bifeprunox is a partial dopamine-receptor agonist under investigation for the treatment of patients with schizophrenia.If approved, bifeprunox may serve as an additional option for the acute and maintenance treatment of schizophrenia.

In a meta-analysis, inhaled corticosteroids were associated with a risk of oropharyngeal adverse events.

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

Oral estrogen use in postmenopausal women may elevate the risk of venous thromboembolism (VTE); however, the use of transdermal estrogen does not appear to increase the risk of VTE.

A new formulation for azithromycin, an antibacterial agent, is now approved by FDA for the treatment of bacterial conjunctivitis.

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

First-time generic drug approvals: Zolpidem immediate-release; nimodipine

The latest FDA action (through June 2007) related to sipuleucel-T (Provenge), tramadol (CIP-Tramadol ER), isotretinoin (CIP-Isotretinoin), bazedoxifene (Viviant), irbesartan plus hydrochlorothiazide (Avalide), prednisolone 1.0% plus tobramycin 0.3% ophthalmic suspension (T-Pred), pixantrone, SPRC-AB01

Retapamulin ointment, 1% is now approved by FDA as an antibacterial agent for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes.

Montelukast, a leukotriene receptor antagonist, is now approved by FDA for the prevention of exercise-induced bronchoconstriction.

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

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

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.