Formulary Watch |

FDA pipeline preview, July 2007

The latest FDA action (through July 2007) related to tramadol (Labopharm), SPD465 (Shire), continuous erythropoiesis receptor activator (Roche), fosaprepitant (Merck), ACAM2000 smallpox vaccine (Acambis), repository corticotropin injection (Questcor), rimonabant (Sanofi-Aventis), tamibarotene (Innovive), mycophenolate (Aspreva), romidepsin (Gloucester), aripiprazole (Otsuka/Bristol-Myers Squibb), AMT 011 (Amsterdam Molecular Therapeutics), aminolevulinic acid (Dusa), cyclosporine A (Novagali), and ARD-07 (Ardana)

Torisel: Temsirolimus recently approved by FDA as new molecular entity

Temsirolimus is now approved by FDA as an antineoplastic agent for the treatment of advanced renal cell carcinoma.

Neupro: Rotigotine transdermal system recently approved by FDA as new molecular entity

Rotigotine transdermal system is now approved by FDA as a nonergoline dopamine agonist for the treatment of for the treatment of signs and symptoms of early-stage idiopathic Parkinson disease.

Doxil: FDA approves new indication for doxorubicin liposome injection

Doxorubicin liposome injection, an anthracycline topoisomerase inhibitor, is approved by FDA in combination with bortezomib for the treatment of multiple myeloma

Lybrel: New formulation of levonorgestrel 90 mcg/ethinyl estradiol 20 mcg recently approved by FDA for the prevention of pregnancy

A new formulation/dosing regimen for levonorgestrel 90 mcg/ethinyl estradiol 20 mcg, a continuous-use combination oral contraceptive approved by FDA for the prevention of pregnancy.

Web-based tools to improve case management

A summary of case management adherence guidelines and online-based case management systems.

From the 56th Annual Scientific Session of the American College of Cardiology: EVEREST: Tolvaptan improves symptoms, volume status in patients with acute decompensated HF but offers no long-term impact

The investigational vasopressin receptor antagonist tolvaptan had no long-term impact on clinical events in patients hospitalized with acute decompensated heart failure (ADHF), but the agent did improve symptoms and volume status over the short term, according to results presented at the 56th annual ACC scientific session.

From the 56th Annual Scientific Session of the American College of Cardiology: ARISE: Succinobucol delivers mixed results in phase 3 trial of patients with ACS

Succinobuccol, an investigational monosuccinic acid ester of probucol, was not associated with a reduction in a composite end point of major cardiovascular events in patients diagnosed with acute coronary syndrome (ACS), but use of the agent did result in improvements on certain secondary end points.

Research demonstrates better first-year results with combination therapy than with monotherapy in patients with early RA

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.

Long-term aspirin use associated with reduced incidence of colorectal cancer

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.

Use of acetaminophen, NSAIDs, and aspirin linked to increased risk of hypertension in men

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.

Tovalt: New formulation recently approved by FDA for zolpidem orally disintegrating tablets

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

Tovalt: New formulation recently approved by FDA for zolpidem orally disintegrating tablets

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

Lawmakers still debating PDUFA IV

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.

More comparative effectiveness research could be beneficial when assessing new medical treatments

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

From the 56th Annual Scientific Session of the American College of Cardiology: Oral thrombin receptor antagonist plus standard antiplatelet therapy does not increase risk of bleeding among patients undergoing PCI

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.

From the 56th Annual Scientific Session of the American College of Cardiology: ECLIPSE: Clevidipine offers promising perioperative blood pressure control in phase 3 trial

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.

From the American Academy of Neurology 59th Annual Meeting: Pregabalin provides relief from fibromyalgia-related pain

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.

From the American Academy of Neurology 59th Annual Meeting: Sequential and combination drug therapies for MS associated with fewer lesions, reduced relapse rates

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

Ibuprofen demonstrated to be superior pain relief for pediatric musculoskeletal injuries

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 associated with fewer hospitalizations for sepsis in patients with CKD undergoing dialysis

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.

PPI treatment beneficial to patients with ulcer bleeding, according to meta-analysis

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.

Inhaled corticosteroids associated with decreased risk of lung cancer in patients with COPD

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.

Prevention and treatment of chemotherapy-induced nausea and vomiting: A review

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.

Bifeprunox: A partial dopamine-receptor agonist for the treatment of schizophrenia

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.

Inhaled corticosteroids may provoke oropharyngeal adverse events

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

FDA action related to medication safety and reliability, June 2007

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

Oral, but not transdermal, estrogen use associated with increased risk of venous thromboembolism

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.

AzaSite: New formulation recently approved by FDA for azithromycin ophthalmic solution 1%

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

FDA actions in brief, June 2007

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