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Solution to COX-2 Inhibitor Dilemma May Be Massage
Cream
Company applies for FDA approval for product they say
will avoid dangers
 June
15, 2005 A company that makes creams for erection enhancement and foot
massage has applied for FDA approval of a cream to deliver COX-2
inhibitor pain relief to the specific area of pain. This, they say,
decreases the total body dose by more than 100 fold that is
administered by the pills recently banned by the FDA. It offers hope to
senior citizens, who are frequent users of pain relievers and most in
danger of heart problems from many of these drugs.
Strategic Science & Technologies LLC of Cambridge,
MA announced today that its platform transdermal technology makes
possible the localized transdermal delivery of COX-2 inhibitors.
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Senior Citizens May Have to Bite-the-Bullet for Pain
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June
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surviving pain, just like cowboys did in the old West movies, when the
doctor was about to operate without an anesthetic. There is a new
observational study out today that joins a list of those saying the risk
of heart attack, particularly in older people, increases with the use of
ibuprofen (Advil) and other commonly used painkillers, as well as COX-2
inhibitors. Read
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Pfizer Takes Bextra Off Market at FDA Request
Agency orders new warning labels on COX-2 and other NSAID medications
April 7, 2005 The Food and Drug Administration
today asked Pfizer to withdraw Bextra from the market and announced new
label warnings for the non-steroidal anti-inflammatory class of drugs,
including COX-2 selective and prescription and non-prescription
(over-the-counter (OTC)) non-selective NSAID medications.
Read more...
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A company spokesperson noted that oral
administration of drugs such as COX-2 inhibitors results in distribution
of the drug throughout the body and requires a significantly higher
total body dose than localized delivery.
What is needed for relief of pain and inflammation
by COX-2 inhibitors is simply an effective dosage at the site of the
problem, the company says.
Reducing the total body dose should minimize or
eliminate the side effects of the drug.
Applying a transdermal preparation containing a
COX-2 inhibitor to the site of the pain provides an effective amount of
drug where it is needed. Depending on the size of the area affected, a
reduction from the oral systemic dose of between 100 and 1,000 fold is
achieved, they say.
The delivery of COX-2 inhibitors is based on the
company's proprietary transdermal delivery platform which forms an
environment in the vehicle that is biophysically hostile to the COX-2
inhibitor. This hostile environment causes the COX-2 inhibitor to prefer
to move from the vehicle into the tissue to which it is applied.
COX-2 inhibitors have recently been implicated in
cardiovascular complications resulting in removal of two products from
the market and a requirement for warning labeling on another.
The company says a major reduction in total body
dose such as that afforded by transdermal delivery is likely to bring
these drugs into an acceptable safety range. For example, if 200 mg of a
COX-2 inhibitor were given orally to treat wrist pain, the same relief
would be achieved by applying only 1/2 mg or less of the drug
transdermally, directly to the wrist. The resultant 400-fold reduction
in total dose of the drug should result in a major reduction in
dangerous side effects.
The spokesperson emphasized that its transdermal
COX-2 inhibitors product is not commercially available and will only
become commercially available with FDA approval.
Their Website is a
www.strategicsci.com.
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