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Weekly Drug News Round Up - July 10, 2013

Zubsolv Approved for Maintenance Treatment of Opioid Dependence

Opioid dependence affects nearly 5 million people across the U.S. Read More...

Opioid dependence greatly impacts the U.S. economy, with about $56 billion spent on the disease per year and almost 17,000 annual deaths from opioid pain relievers. The U.S. Food and Drug Administration (FDA) has approved Orexo’s Zubsolv (buprenorphine/naloxone) as a maintenance treatment for opioid dependence. Zubsolv is a once-daily, sublingual tablet that dissolves under the tongue. Zubsolv has higher bioavailability, faster dissolve time, and a menthol taste. The drug competes with Suboxone, Revia and Vivitrol to help patients beat addiction to painkillers. Sublingual buprenorphine/naloxone is also available generically.

Statin Benefits Outweigh Side Effect Risks: Study

According to the study, statins do not raise the risk for cancer Read More...

Statins are a widely prescribed class of drugs used to lower “bad” cholesterol (LDL) in the blood. In a recent meta-analysis of 135 studies published in Circulation: Cardiovascular Quality and Outcomes, researchers found that the drugs simvastatin (Zocor) and pravastatin (Pravachol) had the fewest side effects in this class of medications but were also the least potent of the statins. Lower doses of statins produced fewer side effects in general. Overall, the researchers found a nine percent increased risk of type 2 diabetes in people taking statins, but concluded that the cardiovascular benefits of statins are greatly outweighed by the risk of type 2 diabetes.

Preventive Drugs for Breast Cancer May Be an Option for High Risk Women

Updated guidelines are meant for women who are cancer-free but at high risk for breast cancer Read more...

An updated guideline issued by the the American Society of Clinical Oncology (ASCO) more strongly suggests that clinicians discuss the option of medication use as a preventive measure in women at high risk of breast cancer. The key points include a recommendation to discuss the use of tamoxifen (Nolvadex) with premenopausal women at high risk, and tamoxifen, raloxifene (Evista), and exemestane (Aromasin) with postmenopausal women. Women at higher risk include those with atypical hyperplasia of the breast, a woman in her 50s with a family history of breast cancer and who has never given birth, and women with the BRCA1 and BRCA2 gene mutations.

FDA Label Update: Olmesartan May Lead to Intestinal Side Effects

Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan Read More...

Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure. FDA is warning that the blood pressure drug olmesartan medoxomil, marketed as a single drug as Benicar and in combination as Benicar HCT, Azor, and Tribenzor, can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. Healthcare providers should advise patients of these risks and patients should contact their doctor if they take an olmesartan-containing product and experience severe diarrhea or significant weight loss.

FDA: Merck’s Investigational Drug for Insomnia Requires Lower Doses

Suvorexant’s novel mechanism is distinct from current treatments

If approved, suvorexant will be the first in a new class of insomnia medicines, called orexin receptor antagonists. In a complete response letter, the FDA notified Merck that the 10 milligram (mg) dose should be the starting dose for most patients in a range of 10 to 40 mg. Higher 15 and 20 mg doses should be reserved for patients who tolerate the drug well but do not have an adequate response at 10 mg; however, the FDA does not support approval of the higher 30 or 40 mg dose. A lower 5 mg dose would need to be available for patients who take concomitant moderate CYP3A4 inhibitors due to a drug interaction.