Formulary Watch |

Azilsartan medoxomil-chlorthalidone fixed combination superior at reducing SBP

A fixed-dose combination of azilsartan medoxomil plus chlorthalidone (Edarbyclor, Takeda) was statistically superior to azilsartan medoxomil coadministered with hydrochlorothiazide at reducing and maintaining systolic blood pressure, according to the results of a phase 3 study published online August 31 in The American Journal of Medicine.

Clinical trials moving to emerging countries

International pharmaceutical companies are increasingly out-sourcing clinical trials to countries in Asia, Latin America, and Eastern Europe, in an attempt to save time, money, and resources, according to a new report from GBI Research.

Smoking quit rate and community-based programs

Retail pharmacies’ smoking cessation programs are effective in helping smokers quit, according to a study published in the September issue of The Annals of Pharmacotherapy.

Early administration of aspirin plus alteplase does not improve outcome in stroke patients

Early administration of intravenous aspirin, in addition to alteplase, does not improve functional outcome at 3 months for patients with acute ischemic stroke, but increases the risk of symptomatic intracranial hemorrhage, according to a study published online August 25 in The Lancet.

Mepolizumab effective in treating eosinophilic asthma

Mepolizumab significantly reduces asthma exacerbations in patients with severe eosinophilic asthma, according to a study published in the August 18 issue of The Lancet.

FDA panel backs tobramycin inhalation powder for patients with cystic fibrosis

An FDA advisory panel voted 13 to 1 that there was adequate evidence of efficacy and safety to support the use of tobramycin inhalation powder (Novartis) for the management of cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa.

FDA grants priority review to TB drug

FDA has granted priority review to bedaquiline, or TMC207 (Johnson & Johnson's Janssen Research & Development), for treatment of multidrug-resistant tuberculosis.

FDA approves new orphan drug for chronic myelogenous leukemia

FDA approved bosutinib (Bosulif, Pfizer) to treat chronic myelogenous leukemia, a blood and bone marrow disease that usually affects older adults.

Medicare Part D plans control drug spending

Drug Watch: Pain

Drug Watch: Pain

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Recent FDA action (through August 2012) related to, ferric carboxymaltose injection, Injectafer, abiraterone acetate, Zytiga, cabozantinib, Exelixis, eltrombopag, Promacta, AEZS-130 oral ghrelin agonist, inhaled nitric oxide, GeNO LLC, gevokizumab, XOMA, calcipotriene cream, Dovonex, montelukast sodium, Singulair, lidocaine topical patch 5%, Lidoderm, filgrastim, Neupogen

Myrbetriq (Mirabegron): A beta-3 adrenergic agonist indicated for the treatment of overactive bladder

New molecular entity: FDA approved Mirabegron (Myrbetriq, Astellas Pharma US) for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency.

An evidence-based review of treatment options for irritable bowel syndrome

Irritable bowel syndrome is functional gastrointestinal disorder that is expensive to treat and can impair quality of life. Current therapies are reviewed.

From the American College of Cardiology Annual Scientific Session & Expo 2012: Formulary decision process at Mayo Clinic leads to abandoning 80-mg of simvastatin

A look at the decision process that lead the Mayo Clinic to abandon the 80-mg dose of simvastatin

Statin use may be linked to increased cataract risk

FDA Actions in Brief August 2012

Recent FDA Approvals (through August 2012) related to (CSL Limited, GlaxoSmithKline Biologicals, ID Biomedical Corp, MedImmune Vaccines, Novartis Vaccines and Diagnostics Limited, Sanofi Pasteur, Genentech, Talon Therapeutics, Amarin, Regeneron Pharmaceuticals, Horizon Pharma, Forest Pharmaceuticals, Onyx Pharmaceuticals, Novartis, Pfizer, Sagent Pharmaceuticals)

Belviq (Lorcaserin): A 5-HT2C receptor agonist indicated to treat certain overweight or obese adults

New molecular entity: FDA approved Lorcaserin (Belviq, Arena Pharmaceuticals GMBH), as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index deemed obese and the presence of at least 1 weight-related comorbid condition.

Former finasteride users with sexual side effects at increased risk for depressive symptoms, suicidal thoughts

Targeting the incretin system: Novel advances in the treatment of diabetes

Incretin-based therapies are now the most promising therapies for type 2 diabetes.

Teduglutide: A novel recombinant analog of human glucagon-like peptide-2 for short bowel syndrome

Teduglutide is a recombinant analog of human glucagon-like peptide-2 that is awaiting FDA approval for the treatment of short bowel syndrome (SBS) as a once-daily subcutaneous injection.

FDA approves new treatment for a type of late-stage prostate cancer

FDA approved enzalutamide (Xtandi, Astellas Pharma U.S. Inc. and Medivation) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.

Growth hormone-releasing hormone appears to help cognitive functioning

Growth hormone-releasing hormone has favorable effects on cognition in healthy older adults and those with mild cognitive impairment, according to a study published online in the August issue of the Archives of Neurology.

Use of ALBC implants may lead to kidney injury

Aminoglycoside-loaded bone cement implants, frequently used in orthopedic surgery, may result in systemic effects that raise aminoglycoside serum concentrations and lead to acute kidney injury, according to a study published July 3 in The Annals of Pharmacotherapy.

Systemic corticosteroid monotherapy has no benefit for acute rhinosinusitis

Systemic corticosteroid monotherapy of prednisone is not effective for patients with acute rhinosinusitis, according to a study published in the August 7 issue of the Canadian Medical Association Journal.

Poor clinical outcomes associated with vitamin D deficiency in critically ill children

Vitamin D deficiency in critically ill children may make them more vulnerable to severe illnesses, according to 2 studies that were published ahead of the September print issue of Pediatrics.

FDA recommends against use of Revatio in children with pulmonary hypertension

FDA issued a Drug Safety Communication on sildenafil (Revatio, Pfizer), following the observation in a long-term extension of a clinical trial in pediatric patients with pulmonary arterial hypertension of an increase in mortality with increasing Revatio dose.

Cystic fibrosis agent may pose cataract risk, FDA says

Children with cystic fibrosis who are taking ivacaftor (Kalydeco) may be at potential risk for cataracts, according to an FDA notification.

FDA approves Linzess to treat certain cases of IBS and constipation

FDA approved linaclotide (Linzess, Ironwood Pharmaceuticals and Forest) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation in adults.

FDA approves new treatment for severe neutropenia in certain cancer patients

FDA has approved tbo-filgrastim (Sicor Biotech UAB, a member of Teva Corporation), or XM02 filgrastim, the first new granulocyte colony-stimulating factor to be approved in the United States in more than 10 years to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia.

FDA approves first drug formulated for children with rare brain tumor

FDA has approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis), a new pediatric dosage form of the anti-cancer drug everolimus (Afinitor, Novartis) used to treat a rare brain tumor called subependymal giant cell astrocytoma.