Formulary Watch |

Formulary Digital Edition, August 2010

Disease-modifying therapy in adult relapsing-remitting multiple sclerosis; Focus on fingolimod; Agents in late-stage development for the management of weight

Drug Watch: Weight management agents (PDF) (August 2010)

Weight management agents in late-stage development.

FDA Actions in Brief August 2010 (Tribenzor, Daiichi Sankyo, Aricept, Eisai and Pfizer, Daytrana, Glassia, Zuplenz, Infergen, Cuvposa)

Recent FDA Approvals (through July 2010) related to Tribenzor, Daiichi Sankyo, Aricept, Eisai and Pfizer, Daytrana, Glassia, Zuplenz, Infergen, Cuvposa

Fingolimod: A potential first-in-class oral therapy for the treatment of relapsing-remitting multiple sclerosis

Fingolimod is an investigational drug being studied for the treatment of relapsing-remitting multiple sclerosis (RRMS) and may represent a first-in-class sphingosine 1-phosphate receptor modulator as well as the first oral therapy for the treatment of RRMS.

Disease-modifying therapy in adult relapsing-remitting multiple sclerosis

Multiple sclerosis (MS) is a significant cause of disability among young adults, more commonly women, and usually strikes patients in the prime of their lives. Despite recent therapeutic advancements, MS remains an incurable, chronic illness. Clinical evidence supports the role of disease-modifying therapy early in the disease course to reduce the number of acute attacks, delay disease progression, maintain quality of life, and prevent disability.

Seven-day transdermal buprenorphine gains FDA marketing approval for the treatment of chronic pain

In patients with low back pain of at least moderate severity and lasting for at least 6 weeks, a new 7-day buprenorphine transdermal system was found to provide better pain control, improve sleep quality, and health-related quality of life as compared with placebo.

Buprenorphine (Butrans): A mu opioid partial agonist analgesic and a Schedule III controlled substance for the management of chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time

New Formulation: Buprenorphine (Butrans) was approved in June for the management of moderate-to-severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time.

FDA warns of serious hematologic reactions with off-label use of quinine sulfate for night-time leg cramps

On July 8, FDA released a "Drug Safety Communication" warning that off-label use of quinine sulfate (Qualaquin, AR Scientific) to treat night-time leg cramps has been found to result in serious and life-threatening adverse effects.

ARBs may increase risk of cancer development, according to meta-analysis

A systematic review and meta-analysis conducted by researchers at Case Western Reserve University School of Medicine and University Hospitals Case Medical Center, Cleveland, suggests that angiotensin-receptor blockers (ARBs) are associated with "a modestly increased risk" of developing cancer (RR increase of 8%, P=.016).

First-time generic approvals August 2010

Generic drugs approved by FDA (through July 2010): Naratriptan hydrochloride tablets, Famotidine for oral suspension, Adapalene cream, Enoxaparin sodium injection, Oxymorphone hydrochloride

Mometasone furoate and formoterol fumarate dihydrate (Dulera): The newest combination inhaled corticosteroid and long-acting beta2-agonist for the management of asthma

New Combination: Mometasone furoate and formoterol fumarate dihydrate (Dulera) was approved in June for the treatment of asthma in patients ?12 years of age.

Transdermal patches effective for treatment of osteoarthritis pain

Seven-day, transdermal buprenorphine patches are as effective as sublingual buprenorphine in the treatment of patients with osteoarthritis pain, according to a randomized, double-blind clinical trial recently published on-line ahead of print in the Journal of Pain and Symptom Management.

Drug recalls, shortages suggest FDA needs greater authority for manufacturer compliance

A number of high-profile drug and biotech manufacturing breakdowns in recent months is raising questions about industry investment in, and commitment to, modern production systems able to meet FDA standards.

Gene testing stakes a claim in the health benefits marketplace

The application of pharmacogenomics-the science of how genetic variations influence drug response-is new to the field of health benefit management, and its potential to improve care and reduce costs is significant.

Updated recommendations for endometriosis released

Women who suffer from endometriosis-related pain should be treated first with conservative, non-surgical approaches and then with more invasive options if pain does not resolve, and hysterectomy only as a last resort, according to a practice bulletin issued by the American College of Obstetricians and Gynecologists (ACOG) and published in the July issue of Obstetrics & Gynecology, reported HealthDay News.

Recent low back pain guidelines offer similar advice

Recent clinical practice guidelines offer similar recommendations for assessing and managing low back pain, and clinicians can improve patient care by adopting these recommendations, according to a review published in the June issue of The Spine Journal, reported HealthDay News.

Folic acid, vitamin B12 do not reduce vascular events

Supplementation with folic acid and vitamin B12 over an extended period does not have a beneficial effect on vascular outcomes in individuals who have had a myocardial infarction, but it also poses no excess cancer risk, according to a study in the June 23/30 issue of the Journal of the American Medical Association, reported HealthDay News.

Gene mutation increases clot risk in women on tamoxifen

Women taking adjuvant tamoxifen for early-stage breast cancer who develop a thromboembolism (TE) are nearly 5 times more likely to carry the factor V Leiden mutation than women on the medication who don't have a TE, according to a study published online June 16 in the Journal of the National Cancer Institute, reported HealthDay News.

Celecoxib linked to lower rate of gastrointestinal events

The cyclooxygenase (COX)-2 selective nonsteroidal anti-inflammatory drug celecoxib is associated with a lower risk of gastrointestinal adverse events than the NSAID diclofenac plus the proton pump inhibitor omeprazole in patients with osteoarthritis or rheumatoid arthritis, according to a study published online June 17 in The Lancet, reported HealthDay News.

Tranexamic acid reduces mortality in trauma patients

Tranexamic acid may be an effective option for reducing bleeding and mortality among trauma patients, without increasing the risk of serious complications such as myocardial infarction, stroke, or pulmonary embolism, according to a study published online June 15 in The Lancet, reported HealthDay News.

Prognosis favorable for most children with epilepsy

About 7 in 10 children who develop epilepsy experience terminal remission, while the condition becomes intractable in only about one in 10, according to a study published online June 14 in Epilepsia, reported HealthDay News.

Costs thwart continued care for many cancer patients

Many cancer survivors delay or forgo medical care due to cost, and cancer survivors aged <65 are more likely to put off or forgo care than those without a history of cancer, according to research published online June 14 in Cancer, reported HealthDay News.

ARBs linked to modestly higher risk of cancer diagnosis

Angiotensin-receptor blockers (ARBs) appear to be associated with a modest increase in risk of a new cancer diagnosis, according to research published online June 14 in The Lancet Oncology, reported HealthDay News.

FDA commissioner announces launch of critical path to TB drug regimens

Recently, FDA Commissioner Margaret Hamburg, MD, addressed a press conference of global representatives from advocacy, industry, academia, and government who convened in Washington, DC, to launch a benchmark international consortium to fight tuberculosis (TB).

New treatment launched for migraines in U.S.

A neurology-focused specialty pharmaceutical company has launched diclofenac potassium for oral solution (Cambia, Nautilus Neurosciences Inc.) for the acute treatment of migraine with or without aura in the United States. FDA approved the prescription medication in June 2009.

Metformin in diabetes linked to lower breast cancer risk

In women with type 2 diabetes, long-term metformin (Glucophage, Merck Serono) use is associated with a lower risk of breast cancer, according to research published in the June issue of Diabetes Care, as reported by HealthDay News.

Less-costly aspirin found useful in newly diagnosed diabetes

The use of regular aspirin by individuals aged 40 and older who have been newly diagnosed with type 2 diabetes is a cost-effective treatment strategy, according to a study in the June issue of Diabetes Care, as reported by HealthDay News.

Year of weekly exenatide beneficial in type 2 diabetes

In patients with type 2 diabetes, a once-weekly formulation of exenatide (Byetta, Amylin Pharmaceuticals) is associated with sustained improvements in glycemic control and body weight over 52 weeks, and patients who switch from a twice-daily to a once-weekly regimen have further improvements in hemoglobin A1C and fasting plasma glucose, according to research published in the June issue of Diabetes Care, as reported in HealthDay News.

Cardio risk for healthy people varies by specific NSAID

The use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) by healthy people is associated with an increased risk of cardiovascular death, but naproxen (Aleve, Bayer Consumer) appears to have a safer cardiovascular risk profile, according to a study published online June 8 in Circulation: Cardiovascular Quality and Outcomes, as reported by HealthDay News.

Risk of GI bleeding varies by NSAID type, dosage

The use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) by healthy people is associated with an increased risk of cardiovascular death, but naproxen (Aleve, Bayer Consumer) appears to have a safer cardiovascular risk profile, according to a study published online June 8 in Circulation: Cardiovascular Quality and Outcomes, as reported by HealthDay News.