BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announced it will sponsor a clinical study comparing the effects of ActiPatch® Therapy to Tylenol® for the treatment of muscle pain and soreness. The study will be conducted in two locations utilizing three groups of subjects, 1) a control group, 2) a group that will utilize ActiPatch Therapy, and 3) a group that will be given acetaminophen in the form of Tylenol®. Patient recruitment has already begun and preliminary data is expected within 60 days.
"As the debate over Tylenol® and other over the counter pain remedies, such as ibuprofen continues, the American public is becoming increasingly leery about taking these medications. We believe drug-free ActiPatch and the Allay Period Relief Patch are safe and highly effective alternatives to these drugs and this study is specifically designed to evaluate our beliefs," commented Andrew Whelan, CEO of BioElectronics, Corp. "We expect increased public attention on the potential dangers of over-the-counter pain medication as the public comment period with the FDA closes on September 30, 2009 and as expected FDA action takes place shortly thereafter. We welcome the opportunity to compare the efficacy of our drug-free technology directly to that of Tylenol®. Considering the market for acetaminophen is valued at $2.6 billion per year within the United States alone, we believe our opportunities relative to this area are significant."
On June 29 and June 30, 2009 the U.S. Government's Food and Drug Administration (FDA) convened a public advisory committee meeting regarding acetaminophen use in both over-the-counter and prescription products, the potential for liver injury, and potential interventions to reduce the incidence of liver injury. Data from both FDA's Adverse Event Reporting System (AERS) and the Acute Liver Failure Study Group (ALFSG) showed that the median daily dose of acetaminophen related to liver injury was 5.0 to 7.5 grams per day, very near the current maximum daily dose of 4.0 grams per day. FDA has stated that taking just a small amount of acetaminophen over the recommended daily dose may lead to liver injury -- even death. For many people, particularly those who consume much alcohol or have underlying liver disease, even 4.0 grams per day may cause liver injury.
The advisory panel recommended decreasing the maximum daily dose to 2.6 grams from 4.0 grams, and also voted to make the 1,000 mg dosage of acetaminophen available only by prescription. The FDA has said that U.S. consumers spent approximate $2.6 billion yearly on 28 billion doses of products that contain acetaminophen. As of April 29, 2010 the FDA will require new labeling to inform consumers about the risk of liver injury when using acetaminophen (such as Tylenol®) and the risk of stomach bleeding when using NonSteroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen (such as Advil® and Motrin®) and naproxen (such as Aleve®).
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