Drugs being developed by Depomed Inc. (DEPO) and Hisamitsu Pharmaceutical Co. (4530) to ease menopausal hot flashes yielded inconsistent results in trials that call into question how meaningful the benefits would be, regulators said. Depomeds gabapentin and Hisamitsus paroxetine mesylate were shown to help women avoid sudden feverish feelings linked to menopause, staff at the Food and Drug Administration said in a report today. The concern is that the reduction in severity and frequency of the flashes varied widely in clinical trials. Each drug, non-hormonal alternatives to the existing medicines, will be discussed on March 4 by agency advisers. Companies have been looking to give women more choices in menopause therapies after hormone treatments were found to increase the risk of breast cancer, heart attack and stroke. Theres a real need for an approved product so women who dont want to use hormones dont have to suffer in silence, Michael Sweeney, chief medical officer for Menlo Park, California-based Depomed, said in a telephone interview. Hot flashes affect about 32 million women in the U.S. and 40 percent choose not to use hormones or arent good candidates for them, Depomed said. The FDA is scheduled to decide on Depomeds pill by … Continue reading →

People who take a certain type of diabetes drug to lower blood sugar levels may be at an increased risk of developing an inflamed pancreas, according to a new study. Glucagonlike peptide 1(GLP-1) therapies that include exenatide - marketed as Byetta by an alliance between Bristol-Myers Squibb and AstraZeneca - and sitagliptin - marketed as Januvia by Merck - have been linked to pancreatitis before in studies on animals and small groups of patients, said the study's lead author. "New therapies and risks are only evaluated when studies are done. We need to know (the drugs) are effective in lowering blood sugar, but we also need to know about risks," said Dr. Sonal Singh, from the Johns Hopkins University School of Medicine in Baltimore. Pancreatitis, which can cause life-threatening complications, is rare but more common in people with type 2 diabetes. Singh said pancreatitis occurs in about three of every 1,000 diabetes patients. The U.S. Centers for Disease Control and Prevention estimates that there are about 19 million Americans diagnosed with diabetes, and another 7 million who have the disease but don't know it yet. In people with type 2 diabetes, the body doesn't produce enough insulin or is resistant … Continue reading →

NEW YORK (Reuters Health) - People who take a certain type of diabetes drug to lower blood sugar levels may be at an increased risk of developing an inflamed pancreas, according to a new study. Glucagonlike peptide 1(GLP-1) therapies that include exenatide - marketed as Byetta by an alliance between Bristol-Myers Squibb and AstraZeneca - and sitagliptin - marketed as Januvia by Merck - have been linked to pancreatitis before in studies on animals and small groups of patients, said the study's lead author. "New therapies and risks are only evaluated when studies are done. We need to know (the drugs) are effective in lowering blood sugar, but we also need to know about risks," said Dr. Sonal Singh, from the Johns Hopkins University School of Medicine in Baltimore. Pancreatitis, which can cause life-threatening complications, is rare but more common in people with type 2 diabetes. Singh said pancreatitis occurs in about three of every 1,000 diabetes patients. The U.S. Centers for Disease Control and Prevention estimates that there are about 19 million Americans diagnosed with diabetes, and another 7 million who have the disease but don't know it yet. In people with type 2 diabetes, the body doesn't produce … Continue reading →

RICHMOND, BRITISH COLUMBIA--(Marketwire - Feb 28, 2013) - London Drugs is proud to be the first in Canada to offer our patients and customers a non-invasive preview into their cholesterol history and health through PreVu - a simple skin cholesterol test. The PreVu test measures the cholesterol found on the bodies'' largest organ, the skin, where cholesterol is accumulated with age. The test is conducted on the palm of the hand in less than five minutes, involves no blood draw, needles or fasting with results available immediately. "We have reviewed the clinical research using this screening technology and have listened to our pharmacists and customers about whether this test would assist in one''s overall health management," said John Tse, London Drugs vice president, pharmacy. "What we learned is that PreVu can assist to either put a patient''s mind at ease if they score low on the skin cholesterol scale or if scoring high, the patient needs to see their doctor to have a blood cholesterol test and further risk assessment conducted." While skin cholesterol isn''t the same as blood cholesterol, it provides valuable information when assessing risk of coronary artery disease (CAD) or heart disease. In October 2012, London Drugs … Continue reading →

(Reuters) - Food and Drug Administration staff said experimental drugs by Depomed Inc and Hisamitsu Pharmaceutical Co Inc showed efficacy in reducing menopausal hot flashes, and highlighted no new risks in comments issued on Thursday. Depomed's shares rose 8 percent on optimism that its drug, which failed to meet pre-defined efficacy goals in studies, may still be approved to address an estimated $1.5 billion market. Depomed's Sefelsa was effective in reducing the frequency and severity of hot flashes related to menopause after four weeks of treatment in studies, but results varied after 12 weeks of treatment, FDA staff observed in a report posted online on Thursday. (http://r.reuters.com/jyx36t) Japanese drugmaker Hisamitsu's paroxetine mesylate capsules was shown to be more consistent at reducing the incidence of the condition than at reducing the severity of flashes. (http://r.reuters.com/fab46t) Both drugs are vying to become the first approved, non-hormonal drug to treat menopausal hot flashes. Most women going through menopause experience these flashes, a complex set of feelings that start with warmth and redness, accompanied by sweating, palpitations and anxiety that typically lasts several minutes. About 13 million of nearly 32 million women who experience hot flashes during menopause seek treatment in the United States, … Continue reading →