FREDERICK, MD -- 08/24/09 --
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®).
About BioElectronics Corporation
BioElectronics Corporation is the maker of ActiPatch® Therapy,
RecoveryRx(TM) Devices, HealFast(TM) Therapy (www.healfasttherapy.com) and
the Allay(TM) family of inexpensive, disposable drug-free anti-inflammatory
devices. For more information please see
http://www.BioElectronicsCorp.com.
Tylenol is a registered trademark of McNeil Pharmaceutical, Inc.
Advil is a registered trademark of Wyeth Consumer Healthcare
Motrin is a registered trademark of McNeil-PPC, Inc.
Aleve is a redshirt trademark of Bayer Healthcare, LLC
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