Opioid abuse and dependence: Treatment review and future options; Focus on dronedarone for atrial fibrillation; Agents in late-stage development for pulmonary diseases.
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Intense public scrutiny of drug safety issues is prompting FDA to take a closer look at its program for establishing Risk Evaluation and Mitigation Strategies. Healthcare providers, as well as pharmaceutical companies, believe that the program is being overused, raising costs, and interfering with patient treatment.
Agents in late-stage development for pulmonary disease.
A new case-control study nested within a large database of human immunodeficiency virus (HIV)-infected patients found abacavir initiation was associated with increased odds of having a myocardial infarction, while longer exposure to abacavir was not.
Platelet response to clopidogrel (Plavix) may be enhanced by concomitant use of agents that induce cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2), according to research presented during the 39th annual meeting of the American College of Clinical Pharmacology, Baltimore.
New biologic: Alpha-1-proteinase inhibitor (human) for injection (Glassia) was approved for the treatment of chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor.
Atrial fibrillation (AF) is the most common form of arrhythmia, affecting an estimated 2.2 million people in the United States. The goal of treatment is to reduce symptoms through rate or rhythm control and to prevent a cardioembolic event. Dronedarone (pronounced droe'' ne' da rone) is a noniodinated benzofuran derivative with characteristics of all 4 Vaughan-Williams antiarrhythmic classes. A search in clinicaltrials.gov for dronedarone phase 3 studies yielded 5 randomized controlled studies that investigated the efficacy and safety of the drug.
Recent FDA Approvals (through August/September 2010) related to Gilenya, Prolia, Krystexxa, Faslodex, Protopam Chloride, Ozurdex, Suboxone Film, Saphris, Tekamlo, Beyaz.
Tocilizumab (Actemra), an interleukin-6 receptor inhibitor, may be effective in the treatment of patients with rheumatoid arthritis who have an inadequate response to anti-tumor necrosis factor-α therapy, according to research presented here at the 39th annual meeting of the American College of Clinical Pharmacology, Baltimore.
Non-Hodgkin's lymphoma (NHL) has several subtypes, with subtle variations, which leads to reduced effectiveness of standardized therapies. The introduction of rituximab, which targets B-cells, has had a positive effect on the management of NHL, but much still needs to be accomplished.
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Pain is a significant medical problem and choosing the appropriate treatment may be complex. Opioids are considered a gold standard in the treatment of pain and as pain management has become a more prominent strategy, opioid dependence has become more frequent. The misuse and abuse of opioids have also increased. Successful management of opioid dependence requires utilization of both pharmacologic and nonpharmacologic treatment.
New combination: Dutasteride and tamsulosin (Jalyn) was approved by FDA for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate.
QRxPharma has announced a successful interim analysis of its final MoxDuo IR pivotal phase 3 study required for new drug application (NDA) submission.
A systematic review and meta-analysis conducted by researchers at the University of Connecticut (UCONN) School of Pharmacy, Storrs, Conn., and Hartford Hospital, Hartford, Conn., suggest that using metformin along with atypical antipsychotic agents (such as olanzapine, risperidone, quetiapine, and clozapine) may result in better anthropometric measurements and decreased insulin resistance.
In mid July, FDA released a drug safety communication to rheumatologists and family physicians warning them that the use of leflunomide (Arava, Sanofi-Aventis)-a drug to treat rheumatoid arthritis-has been linked to an increased risk of severe liver injury.
In mid August, FDA issued a ?Proposal to Withdraw Marketing Approval and Notice of Opportunity for a Hearing? to the companies that manufacture midodrine hydrochloride (ProAmatine, Shire Development Inc., and generics by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories).
On August 12, 2010, FDA released a safety communication to prescribers and patients warning that lamotrigine (Lamictal, Lamictal ODT, Lamictal CD, Lamictal XR), a medication commonly used for seizures in children ≥2 years of age and bipolar disorder in adults, can cause an inflammation of the meninges (the protective membranes that cover the brain and spinal cord) called aseptic meningitis.
FDA has launched a performance management system designed to advance transparency, public participation, and collaboration in the work of government.
Boehringer Ingelheim announced Aug. 29 that results from a pre-specified, retrospective, unblinded subanalysis of the RE-LY trial ? the largest atrial fibrillation outcomes trial ever conducted ? were published in The Lancet.
A new genetic substudy of PLATO (A Study of PLATelet Inhibition and Patient Outcomes) showed that the effects on a combined primary end point of cardiovascular death, myocardial infarction, or stroke seen in patients with acute coronary syndromes (ACS) who received the investigational oral antiplatelet treatment, ticagrelor (Brilinta, AstraZeneca), were maintained, whether or not they had the genetic variability that has been previously shown to affect a patient?s response to clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi Pharmaceuticals).
The Academy of Managed Care Pharmacy (AMCP) has responded to a request from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) in the Department of Health and Human Services (HHS). In this request, ASPE indicates that it is developing a national inventory of comparative effectiveness research (CER) and CER-related information driven by the American Recovery and Reinvestment Act, signed into law by President Obama in 2009.
The Academy of Managed Care Pharmacy (AMCP) has provided comments in response to a June 17 Federal Register notice on the Interim Final Rules for Group Health Plans and Health Insurance Coverage Relating to Status as a Grandfathered Health Plan Under the Patient Protection and Affordable Care Act, also known as The Grandfathering Rule.
A study evaluating the cardiovascular outcomes related to rimonabant was discontinued because of concerns regarding the risk of suicide associated with the weight-loss drug, according to a report in the Aug. 14 issue of The Lancet, as reported by HealthDay News.
A revised system of classification for rheumatoid arthritis (RA) may allow for earlier identification of the disease, earlier treatment, and ultimately better patient outcomes. The new system has been published in the September issues of the Annals of the Rheumatic Diseases and Arthritis & Rheumatism, as reported by HealthDay News.
Hospitalization rates for peptic ulcer disease and Helicobacter pylori infection have decreased substantially since 1998, according to an analysis in the September issue of Emerging Infectious Diseases, as reported by HealthDay News.
There appears to be no association between the use of oral bisphosphonates and the risk of esophageal or gastric cancer, according to research published in the Aug. 11 issue of the Journal of the American Medical Association, as reported by HealthDay News.
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