Drug News
Drug shows promise against diabetic eye condition
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Eye injections of the drug Lucentis (also known as ranibizumab) appear to be useful in the treatment of a potentially blinding eye condition called macular edema that can afflict people with diabetes, a small study suggests.
“The results are impressive,” lead author Dr. Quan Dong Nguyen, from Johns Hopkins Wilmer Eye Institute in Baltimore, said in a statement. However, “we will not know until we begin a larger clinical trial what the long-term benefits of the drug might be.”
Women on osteoporosis drug can discontinue use with no risk
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A long-term study of the most widely used osteoporosis drug has found that many women can discontinue the drug after five years without increasing their fracture risk for as long as five more years.
The study on alendronate was led by researchers at the University of California, San Francisco, and findings are published in the December 27, 2006 issue of the “Journal of the American Medical Association.” The research also showed that women at very high risk of painful spine fractures might be better-off continuing treatment.
“This has important implications as it has not been known whether treatment of osteoporosis should be continued indefinitely,” said lead author Dennis Black, PhD, professor in the UCSF Department of Epidemiology and Biostatistics. “Because women with osteoporosis, particularly older post-menopausal women, often need to take multiple drugs, this would be welcome news for this group.”
“Erectile Dysfunction” Drugs Heighten Natural Anti-Cancer Activity
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Sildenafil and other “impotence drugs” that boost the production of a gassy chemical messenger to dilate blood vessels and produce an erection now also show promise in unmasking cancer cells so that the immune system can recognize and attack them, say scientists at the Johns Hopkins Kimmel Cancer Center.
Tests at Hopkins on mice with implanted colon and breast tumors showed that tumor size decreased two- and threefold in sildenafil-treated animals, compared to mice that did not get the drug. In mice engineered to lack an immune system, tumors were unaffected, proof of principle, the scientists say, that the drug is abetting the immune system’s own cellular response to cancer.
Pfizer shares plunge after cholesterol drug fails
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Shares in Pfizer Inc fell around 14 percent in European and pre-opening U.S. trade on Monday after the world’s biggest drugmaker scrapped development of its most important experimental medicine.
Pfizer halted work on torcetrapib, which was designed to raise levels of “good” HDL cholesterol, because of increased deaths and heart problems among patients given the product in a late-stage trial.
Free Viagra spices up small town life
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The mayor of a small Brazilian town has begun handing out free Viagra, spicing up the sex lives of dozens of elderly men and their partners.
“Since we started the free distribution of sexual stimulants, our elderly population changed. They’re much happier,” said Joao de Souza Luz, the mayor of Novo Santo Antonio, a small town in the central state of Mato Grosso.
Study Evaluates Two Medications for ADHD
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University of Illinois at Chicago researchers are comparing two drugs commonly used to treat attention deficit hyperactivity disorder to determine if genetic factors predict which children will respond to either or both drugs.
Many different medications are used to treat ADHD, including stimulants and non-stimulants, says Dr. Mark Stein, principal investigator of the National Institute of Mental Health-funded study and director of the Hyperactivity, Attention, and Learning Problems Clinic at UIC.
“Unfortunately, clinicians are unable to predict in advance who will respond or not respond to a particular medication,” Stein said.
AMITIZA™ (lubiprostone) Phase III Constipation Trial Results
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In recent studies, AMITIZA™ (lubiprostone) demonstrated improvements in relief of symptoms associated with irritable bowel syndrome with constipation (IBS-C), such as abdominal bloating and discomfort. Results of sub-analyses from two Phase III chronic constipation studies of AMITIZA, the first selective chloride channel activator approved by the FDA for the treatment of chronic idiopathic constipation in adults, were presented today at the 71st American College of Gastroenterology (ACG) Annual Scientific Meeting.
“The results suggest that AMITIZA may have the potential to improve the symptoms associated with IBS-C, a functional bowel disorder that causes abdominal pain or discomfort, bloating and constipation,” said Anthony Lembo, M.D., assistant professor of medicine and director of the Motility Center, Harvard Medical School. “Additional studies are needed to evaluate the potential for AMITIZA with these patients; however, it would benefit patients to have additional treatment options.”
US doctors accuse company of influencing drug policy
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Eli Lilly and Co. may have improperly influenced guidelines on the treatment of a dangerous infection called sepsis in order to sell more of an expensive new drug, three federal researchers said on Thursday.
Lilly did not deny trying to influence the guidelines by hiring a marketing firm and by paying doctors and ethicists to launch a campaign about choosing which patients to treat in the emergency room.
But the company said its efforts were educational, and had the goal of making sure only the appropriate patients were treated with the drug, called Xigris.
Congress urged to act on US FDA safety reforms
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Editors at a major medical journal and members of a drug-safety advisory panel joined calls on Monday for major changes to improve the U.S. Food and Drug Administration’s oversight of medicines on the market.
A New England Journal of Medicine editorial urged the U.S. Congress to adopt recommendations made by an Institute of Medicine (IOM) panel last month to bolster drug safety.
The IOM report pressed Congress to give the FDA more staff, funding and power—including the ability to require the drug industry to do post-approval studies and change warning labels.
FDA wants another trial of Lilly diabetic eye drug
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Eli Lilly and Co. said Friday that U.S. regulators want an additional three-year clinical trial for its treatment for eye problems brought on by diabetes.
Lilly said such a trial would take up to five years to complete. It said it is weighing options for the further development of the treatment, called ruboxistaurin mesylate.
The Food and Drug Administration is calling for additional efficacy data before it will consider approving the molecule for the treatment of moderate to severe diabetic retinopathy.
FDA approves quick test for lead exposure
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A new blood test that measures lead exposure and gives results in three minutes has won U.S. approval, a Food and Drug Administration spokeswoman said on Monday.
The test, made by privately held Magellan Biosciences Inc., improves on older ones that had to be sent to a laboratory and could take two weeks or more to deliver results, FDA spokeswoman Susan Bro said.
The new test could be especially useful for health-care workers who test children in schools for lead exposure, Bro said. Blood is drawn by pricking a finger.
New method of developing antibiotics
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University of Minnesota and University of Michigan researchers have discovered a new method of developing antibiotics, an important step in fighting the growing number of drug-resistant infections.
In two articles published in the current online issue of Nature Chemical Biology, researchers describe an approach that is more efficient—and environmentally friendly—in developing new antibiotics, those needed to kill the increasing number of infections resistant to multiple drugs.
“We’re striving to create new drugs that can have a positive impact on the growing threat of infectious diseases,” says Robert Fecik, Ph.D., an assistant professor of Medicinal Chemistry at the University of Minnesota College of Pharmacy and one of the lead authors of the study. “This type of research can help us make new antibiotic molecules.”
Researcher Lights the Way to Better Drug Delivery
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A Purdue University researcher has explained for the first time the details of how drugs are released within a cancer cell, improving the ability to deliver drugs to a specific target without affecting surrounding cells.
“As a general strategy, the indiscriminate delivery of drugs into every cell of the body for the treatment of a few specific pathologic cells, such as cancer cells, is a thing of the past,” said Philip Low, the Ralph C. Corley Distinguished Professor of Chemistry. “Most new drugs under development will be targeted directly to the pathologic, disease-causing cells, and we have shed light on the details of one mechanism by which this is achieved.”
An understanding of the cellular process that leads to the release of targeted drugs is a major advancement for the field, he said.
Cheaper blood thinner just as effective, study says
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Injections of the blood thinner heparin treat blood clots just as effectively as a top-selling version that is many times more expensive, researchers said on Tuesday.
To treat deep vein thrombosis, which appears most often as blood clots in the legs, injections of low-molecular weight heparin such as Sanofi-Aventis’ blockbuster Lovenox and Pfizer’s Fragmin have been increasingly seen as more convenient and effective than original heparin.
The original blood thinner, called unfractionated heparin and derived from pig tissues, is given intravenously in the hospital and patients are closely monitored.
Glaxo adds strong heart risk warning to ADHD drug
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GlaxoSmithKline Plc has said it will add a strong warning about possible heart risk to its attention deficit hyperactivity drug Dexedrine, according to a letter posted on the U.S. Food and Drug Administration’s Web site on Monday.
Packaging for the drug will also include information about possible psychiatric adverse events, like hallucinations and mania, linked to stimulants, according to the letter dated August 4.
Inclusion of the new warning comes after two FDA advisory panels offered conflicting opinions over how strong such warnings should be.
