Formulary Watch |

Olmesartan medoxomil, amlodipine, and hydrochlorothiazide (Tribenzor): A new 3-drug combination product for the treatment of hypertension

New combination: Olmesartan medoxomil, amlodipine, and hydrochlorothiazide (Tribenzor) have been recently approved by FDA as an initial therapy to treat hypertension in patients likely to need multiple drugs to achieve their blood pressure goals.

Comparative effectiveness research studies will alter methods for assessing the value of new therapies and coverage calculations

PCORI now has a chairman and board representing all stakeholders to take on the daunting task of setting the national CER agenda, developing systems for funding research, establishing standards and methods for comparative studies, and devising programs to disseminate results to practitioners and to the public.

First-time generic approvals November 2010

Generic drugs approved by FDA (through October 2010): Extended-release suspension containing hydrocodone polistirex and chlorpheniramine polistirex

FDA Pipeline Preview, November 2010 (Qnexa, Linjeta, JZP-6, Bydureon, Zalbin, Staccato loxapine, Tapentadol extended-release oral analgesic, AVP-21D9, 1% tenofovir vaginal gel, AFM 13, hGH-CTP, Rozrolimupab, Nefecon, SB1518 JAK2 inhibitor)

Recent FDA action (through, October 2010) related to Qnexa, Linjeta, JZP-6, Bydureon, Zalbin, Staccato loxapine, Tapentadol extended-release oral analgesic, AVP-21D9, 1% tenofovir vaginal gel, AFM 13, hGH-CTP, Rozrolimupab, Nefecon, SB1518 JAK2 inhibitor.

FDA issues complete response letter for lorcaserin

FDA has issued a complete response letter (CRL) for lorcaserin's (Arena and Eisai) New Drug Application. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in some patients who are obese or patients who are overweight (and have at least 1 weight-related co-morbid condition.

FDA approves Botox for chronic migraine

OnabotulinumtoxinA (Botox, Allergan) has been approved by FDA as prophylactic treatment of headaches in adults with chronic migraine. It is the first clinically studied prophylactic treatment to receive FDA approval specifically for this debilitated patient population.

FDA approves first once-daily eyedrop for inflammation and pain after cataract surgery

Bromfenac ophthalmic solution (Bromday, ISTA Pharmaceuticals) 0.09% has been granted FDA approval as a once-daily prescription eyedrop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.

First warfarin replacement approved

Dabigatran etexilate (Pradaxa, Boehringer Ingelheim) has received FDA approval for the prevention of stroke and blood clots in patients with atrial fibrillation. It is the first replacement for warfarin to win FDA approval.

Schizophrenia study stopped early due to success

Because of successfully meeting efficacy criteria at a protocol-specified interim analysis, an independent data monitoring committee (IDMC) has recommended the early termination of Otsuka?s phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.

Giving more people statins could cost effectively prevent heart attacks

Giving cholesterol-lowering statin drugs to more people could be a cost-effective way of preventing heart attacks, US researchers said Sept. 27, as reported by Reuters. The study was published in Circulation.

Oral naproxen, sumatriptan provides comparable post-emergency department recurrent headache relief

For patients experiencing headache recurrence within 48 hours of an emergency department discharge, naproxen 500 mg or sumatriptan 100 mg taken orally relieves recurrent primary headache (including migraine, tension type, and cluster headaches) pain comparably, according to a report published in a recent issue of Annals of Emergency Medicine.

FDA orders halt to production and marketing of unapproved single-ingredient oral colchicine

FDA has requested that all companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever, stop the manufacturing of this drug.

DMARDs, glucocorticoids, biologics similar for treatment of RA

Treatment of rheumatoid arthritis (RA) with disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, biologics, or a combination of these agents significantly reduces radiographic evidence of joint destruction, with no advantage seen for patients whose treatment includes biologics, according to research published in the October issue of Arthritis & Rheumatism.

No benefit to early chemo in ovarian cancer relapse

For women whose ovarian cancer has been in remission, restarting chemotherapy early on the basis of heightened CA125 concentration does not improve survival compared with postponing treatment until symptoms of relapse appear, according to a study published in the Oct. 2, cancer-themed issue of The Lancet.

Giving more people statins could cost effectively prevent heart attacks

Giving cholesterol-lowering statin drugs to more people could be a cost-effective way of preventing heart attacks, US researchers said Sept. 27, as reported by Reuters. The study was published in Circulation.

FDA grants ipilimumab priority review

Ipilimumab (Bristol-Myers Squibb) intended to treat patients with stage III or IV metastatic melanoma has been granted priority review by FDA.

Prophylactic antivirals reduce corneal disease recurrences

Individuals with ocular herpes simplex virus treated with prophylactic oral antibiotics appear to be at a lower risk of recurrence of epithelial keratitis, stromal keratitis, conjunctivitis, and blepharitis, according to research published in the September issue of the Archives of Ophthalmology, as reported by HealthDay News.

Supplements glucosamine and chondroitin don't help in treatment of arthritis

Two popular supplements used to treat joint pain don't work and health authorities should stop paying for them, according to a new study, as reported by HealthDay News

Simplified heart-risk guideline may miscalculate chance for coronary event

A method that is widely used to predict the risk of a major coronary event may over- or underestimate the risk for millions of Americans, according to a study directed by a researcher at the San Francisco VA Medical Center (SFVAMC) and the University of California, San Francisco (UCSF).

Use of medications for insomnia or anxiety may increase mortality risk

Taking medications to treat insomnia and anxiety increases mortality risk by 36%, according to a study by the School of Psychology at the University of Laval (Canada). Details of the study were published in the September issue of the Canadian Journal of Psychiatry.

GBCAs to include warning on NSF risk

FDA is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of nephrogenic systemic fibrosis (NSF), a rare and potentially fatal condition, if the drug is administered to certain patients with kidney disease.

Panel says bisphosphonate use may lead to atypical thigh-bone fractures

While bisphosphonate drugs are highly effective in reducing common bone fractures in individuals with osteoporosis, a task force announced that the drugs, when used long term, may be associated with atypical but serious fractures of the thigh bone.

FDA approves first oral MS treatment

FDA has approved fingolimod (Gilenya, Novartis), 0.5 mg daily, as a first-line treatment to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS). It is the first oral MS treatment approved in the United States.

Formulary Digital Edition, September/October 2010

Opioid abuse and dependence: Treatment review and future options; Focus on dronedarone for atrial fibrillation; Agents in late-stage development for pulmonary diseases.

Risk management, drug safety raise challenges for sponsors and healthcare providers

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.

Drug Watch: Pulmonary disease agents (PDF) (September/October 2010)

Agents in late-stage development for pulmonary disease.

Some antiretroviral drugs used to treat HIV associated with an elevated risk of myocardial infarction

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.

CYP1A2-inducing medications improve platelet responsiveness to clopidogrel

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): A new chronic augmentation and maintenance therapy for emphysema due to alpha-1-antitrypsin deficiency

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.

Dronedarone for atrial fibrillation: An update of clinical evidence

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.