Formulary Watch |

Actavis to buy Warner Chilcott for $8.5 billion in stock transaction

Actavis Inc. announced May 20 its plans to acquire Warner Chilcott in a stock transaction deal, which is worth approximately $8.5 billion. The merger is expected to create a global specialty pharmaceutical company serving the women’s health, gastroenterology, urology, and dermatology therapeutic sectors, according to a joint company release.

Senators introduce revised draft compounding bill

Senators from the Health, Education, Labor and Pensions (HELP) Committee have introduced a revised version of its draft compounding bill to help improve the safety of compounded human and animal drugs, following feedback earlier this month from stakeholders, including the American Society of Health-System Pharmacists (ASHP).

FDA approves Bayer’s Xofigo for treatment of prostate cancer

FDA has approved radium Ra 223 dichloride (Xofigo, Bayer) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

Pharmacist-physician collaborative care effective in T2DM

Pharmacists working in a collaborative relationship with physicians in different practice settings were able to help more patients with type 2 diabetes achieve glycemic control without adding to the medication burden, according to a report published May 8 in The Annals of Pharmacotherapy.

Improvement needed in HCV testing, reporting

Hepatitis C testing and reporting must be improved as the mortality rate of HCV is high among those who are relatively young, according to a new study published in the May 7, 2013, Morbidity and Mortality Weekly Early Release on its website.

Daily fatty acid intake doesn’t reduce CV mortality risk

Patients with multiple cardiovascular (CV) risk factors are not able to reduce their mortality risk from CV causes with daily n-3 polyunsaturated fatty acid intake, according to a long-term Italian study published May 9 in the New England Journal of Medicine.

CDC issues new HCV guidelines

Because of the need for early detection, improved antiviral agents, and changes in the availability of commercial Hepatitis C virus (HCV) tests, the Centers for Disease Control and Prevention (CDC) has issued a new guidance for clinicians and laboratorians.

FDA denies request to block generic versions of Opana ER

FDA has denied Endo Health Solutions' petition to block generic forms of its opioid agonist Opana ER, which contains oxymorphone. FDA’s decision comes just weeks after it nixed generic OxyContin and approved abuse-deterrent labeling for reformulated OxyContin (Purdue Pharma).

FDA approves Breo Ellipta for long-term treatment of COPD

FDA has approved fluticasone furoate and vilanterol inhalation powder (Breo Ellipta, GlaxoSmithKline and Theravance), an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.

Adhering to generic cholesterol-lowering drugs is associated with lower overall costs of care

Individuals who regularly take statins to reduce high cholesterol will see lower hospitalization rates according to a study presented at the Academy of Managed Care Pharmacy’s 25th Annual Meeting & Expo in San Diego, in April.

FDA warns pregnant women to not use certain migraine prevention medicines containing valproate

Migraine prevention drugs used during pregnancy can cause decreased IQ scores in children born to mothers who take these medications, according to an FDA alert.

Zoster vaccine effective but underused in elderly

Zoster vaccination was associated with a reduction in post-herpetic neuralgia among those who are aged 65 and older, according to a study, published in PLoS Medicine. However, they also found that the use of the shingles vaccine was also very low among certain population groups

Investigational new agent targets chronic hepatitis C virus genotype 1

Interim data from a phase 2, multicenter, randomized, dose-ranging clinical trial evaluating the safety and antiviral activity of MK-5172 (Merck), for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection, was presented at the 2013 International Liver Congress, 48th annual meeting of the European Association for the Study of the Liver, in Amsterdam.

Boceprevir triple therapy safely, effectively used in patients with HCV G1 infection and compensated cirrhosis

Data from a meta-analysis of 5 boceprevir (Victrelis, Merck) phase 3 clinical studies was presented at the 2013 International Liver Congress, 48th annual meeting of the European Association for the Study of the Liver, in Amsterdam.

FDA approves combination agent to help lower LDL cholesterol

FDA has approved ezetimibe and atorvastatin (Liptruzet, Merck) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet, according to the manufacturer.

Leukemia experts protest skyrocketing drug prices

A group of doctors and researchers is protesting the high cost of certain cancer drugs and is urging pharmaceutical companies to make changes.

Dietary fiber lowers risk of first stroke: Study

Greater dietary fiber intake is significantly associated with lower risk of first stroke, according to a recent study published in Stroke.

Glutamine, antioxidants: Don’t offer to critically ill patients

For critically ill adults with multiorgan failure, early supplementation with glutamine or antioxidants does not improve clinical outcomes, and glutamine may increase the mortality rate of this patient population, according to a study published in the April 18 issue of the New England Journal of Medicine.

FDA approves OTC Plan B One-Step for ages 15 and older

Women who are 15 years and older will have access to emergency contraceptive Plan B One-Step (levonorgestrel) as an over-the-counter (OTC) medication that will no longer be sold behind the counter, according to the FDA.

FDA approves the first 4-Factor Prothrombin Complex Concentrate for warfarin reversal

FDA has approved Prothrombin Complex Concentrate [Human] (Kcentra, CSL Behring), the first non-activated 4-factor PCC indicated for the urgent reversal of warfarin in patients with acute major bleeding.

5-ARI does not affect prostate cancer mortality

Eighteen years of follow-up of the Prostate Cancer Prevention Trial (PCPT) suggests that 7 years of treatment with the 5-alpha-reductase inhibitor finasteride (Proscar) for prostate cancer prevention does not appear to affect mortality but does reduce the risk of a prostate cancer diagnosis.

Efficacy of androgen receptor blockade in castration-resistant prostate Ca not dependent on age

Older men with metastatic castration-resistant prostate cancer (mCRPC) derive a similar if not superior survival benefit from treatment with enzalutamide as do younger men, according to a post-hoc analysis of the phase III AFFIRM trial.

[INFOGRAPHIC] Medication use in autism spectrum disorders: What is the evidence?

Autism spectrum disorders (ASD) are complex neurodevelopmental disorders that involve significant social functional impairment and behavioral inflexibility. Autism is the most severe form of ASD and includes significant impairment in communication skills. Treatment of ASD is complex and involves a comprehensive educational interventional plan. Medications are used only as adjuncts, and only in cases in which maladaptive behaviors are severe or life-threatening, or to enable a patient to participate in their behavioral therapies. The most commonly used medications include second-generation antipsychotics (SGAs), selective serotonin reuptake inhibitors (SSRIs), and psychostimulants. Risperidone and aripiprazole are the only medications to carry an FDA indication to treat ASD-related symptoms. There is interest in using newer agents, such as atomoxetine, galantamine, rivastigmine, and memantine, to treat ASD-associated symptoms, but data are lacking to support their use.

Little survival difference seen with kidney cancer agent

Use of tivozanib, an experimental tyrosine kinase inhibitor (TKI) with increased specificity and potency for the vascular endothelial growth factor (VEGF) receptor, as initial targeted therapy for patients with advanced renal cell carcinoma did not translate into improved overall survival compared with sorafenib (Nexavar) in a phase 3 clinical trial.

Care management programs key to helping deal with complexities of hepatitis C medication adherence

The standard of care for hepatitis C (HCV) was uprooted in 2011. Prevailing treatment involved a combination of 2 drugs-pegylated-interferon and anti-viral ribavirin-taken for 1 year. Two new protease inhibitors, boceprevir and telaprevir, joined the regimen.

New biologic Xeljanz Tofacitinib Pfizer

In November 2012, FDA approved tofacitinib (Xeljanz, Pfizer) 5 mg tablets for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have not had an adequate response to methotrexate or are intolerant to methotrexate. Tofacitinib, an oral non-biologic disease-modifying antirheumatic drug (DMARD) can be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. It is contraindicated for use with biologic DMARDs or with immunosuppressive agents, such as azathioprine and cyclosporine.

Medication reconciliation efforts meeting needs and showing promise

Medication Reconciliation, “Med Rec” as it has come to be known, is recognized as an important part of the growing practice of medication management and a critical step in improving the care of patients in all settings. Despite the many challenges associated with implementation of a successful Med Rec program, the potential for significant value drives the ongoing effort to find scalable, cost-effective solutions.

Anticoagulant use predicts survival in metastatic prostate cancer

Anticoagulation while on docetaxel (Taxotere) chemotherapy is an independent predictor of survival in men with metastatic castration-resistant prostate cancer (mCRPC).

FDA Drug Approvals

Pipeline preview, FDA actions in brief

Ponatinib: An oral tyrosine kinase inhibitor for the treatment of chronic myelogenous leukemia and Philadelphia chromosome–positive acute lymphoblastic leukemia

Ponatinib (Iclusig; Ariad Pharmaceuticals) is an oral tyrosine kinase inhibitor (TKI) that was approved by FDA on December 14, 2012, for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase chronic myelogenous leukemia (CML) that is resistant or intolerant to previous TKI therapy, and for Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (Ph+ALL).