Formulary Watch

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.

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).

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.

FDA has approved NovoSeven RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) in an 8-mg vial size, making the hemophilia A or B with inhibitors treatment available in 1-, 2-, 5-, and 8-mg vials, Novo Nordisk announced on Aug. 10. The 8-mg vial allows a rapid initiation and administration of the medication for those patients who need a larger dose.

FDA approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease, according to Genentech Inc. on Aug. 10.

Infections with the deadly methicillin-resistant Staphylococcus aureus (MRSA) bacteria that begin in hospitals and other healthcare settings have declined 28% over a 4-year period, according to a new Centers for Disease Control and Prevention (CDC) study of about 15 million people. The study was published in the Aug. 11 issue of the Journal of the American Medical Association, as reported by HealthDay News.

Patients taking newer antiepileptic drugs (AEDs) that are associated with a high risk of depression may have an elevated risk of self-harm or suicidal behavior, but other groups of AEDs do not appear to carry the same risk, according to research published in the July 27 issue of Neurology, as reported in HealthDay News.

Oral antidiabetic (OAD) agents generally result in a maximum 1.5% drop in hemoglobin (Hb) A1C levels, with sulfonylureas and thiazolidinediones having a slightly more beneficial effect than other classes of oral agents, according to research published in the August issue of Diabetes Care, as reported by HealthDay News.

Investigational combination treatment with sustained- release (SR) naltrexone and bupropion (Contrave, Orexigen Therapeutics)?plus lifestyle modification, appears effective in helping people lose 5% or more of their excess body weight, according to research published online July 30 in The Lancet, as reported by HealthDay News.

The use of lorcaserin, along with behavioral modification, is associated with weight loss and subsequent weight maintenance compared with placebo, according to a study published in the July 15 issue of the New England Journal of Medicine, HealthDay News reported.

Meningococcal polysaccharide vaccine (MPV4) does not appear to be associated with post-vaccination Henoch-Schönlein purpura (HSP) in 16- to 20-year-olds, according to research published online July 12 in Pediatrics, HealthDay News reported.

A high proportion of pediatric, randomized controlled trials (RCTs) have a high risk for bias, particularly those that are industry-funded or involve assessment of behavioral/educational interventions, but trial registration is linked to less risk of bias, according to research published online July 12 in Pediatrics, HealthDay News reported.

Investigational triple antihypertensive combination therapy lowers blood pressure more effectively than dual therapy in diabetic patients with hypertension, according to the results of a subgroup analysis of the TRINITY study.