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Weekly Drug News Round Up - August 1, 2012

Vascepa Approved for Treatment of Severely High Triglyceride Levels

Vascepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA), an omega-3 fatty acid agent Read more...

The U.S. Food and Drug Administration (FDA) has approved Vascepa (icosapent ethyl) as an adjunct to diet for the treatment of adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL). In the MARINE placebo-controlled clinical trial, patients achieved a significant reduction in mean triglyceride levels of 33 percent. Vascepa is the second prescription fish oil agent to be approved by the FDA, behind Lovaza (omega-3-acid ethyl esters). The dose of Vascepa is two capsules by mouth twice a day, and the product is expected to launch in the first quarter of 2013.

FDA Approves Rayos - a Delayed-Release Prednisone

Rayos by Horizon Pharma will be available in 1 mg, 2 mg and 5 mg dosage strengths in the fourth quarter of 2012 Read More...

Rayos (prednisone) is a delayed-release anti-inflammatory and immunosuppressive agent approved for the treatment of rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease. The efficacy of Rayos in the treatment of rheumatoid arthritis was assessed in the 12-week CAPRA-2 trial. A statistically significant improvement in the primary endpoint that measures improvement in tender or swollen joint counts and other clinical measures, known as ACR20, was achieved.

Bath Salts May Lead to Addiction Similar to Cocaine: Study

Study suggests addiction potential, effects of bath salts mimic cocaine Read More...

In July 2012, President Obama signed a federal bill to outlaw several types of synthetic designer drugs, including bath salts that contain the stimulants mephedrone or MDPV. Street drugs known as bath salts have been shown in mice to have a similar effect and addiction potential as cocaine. In the studies, researchers measured the continued efforts of mice to run on a wheel in order to give themselves a reward, which was direct electrical stimulation of the brain pathways involved in reward perception. Intracranial self-stimulation studies show that addictive drugs make self-stimulation more pleasurable. Intracranial stimulation was more rewarding for the mice after administration of either cocaine or mephedrone.

Off-Label Uses of Drugs: More Research Needed in Children

Up to 79 percent of hospital medications, 56 percent of office-based drugs are used “off-label” in pediatrics Read More...

Kids are not just small adults, and this is especially important when it comes to drug treatment. For example, think about stimulants such as methylphenidate (Ritalin) used for attention deficit hyperactivity disorder (ADHD). Stimulants can help calm a child with ADHD, but lead to insomnia in an adult. A review published in Pediatrics states that “off-label” use of drugs, defined as when the drug is used in children but has only been FDA-approved for use in adults, is all too common. Categories in need of additional research include depression, asthma, migraine, schizophrenia and bipolar disorder. Lack of industry dollars, limited nonprofit funding and exclusion of children from studies due to difficult recruitment are listed as possible barriers.

Bone Marrow Transplants Leave Two Men HIV-Free

Next step is to determine if men can remain HIV-free without antiretroviral therapy Read More...

Many patients receiving antiretroviral therapy have latent viral particles in their lymphocytes (white blood cells), even though viral particles are not found in their blood. Researchers report that two HIV-positive men who underwent chemotherapy, and then eventual stem cell transplants for blood cancer and continued to use antiretroviral therapies no longer have detectable levels of HIV in their lymphocytes. However, stem cell transplants cost hundreds of thousands of dollars, can cause serious complications and experts say this method would not be considered as a standard HIV cure. While they do not expect to see bone marrow transplants performed on otherwise healthy HIV patients, these results may open the door for further research towards a cure.