Moderate To Moderately-severe Chronic Pain - Once Daily ULTRAM® ER (Tramadol HCl

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Moderate To Moderately-severe Chronic Pain - Once Daily ULTRAM® ER

(Tramadol HCl) Extended-Release Tablets Now Available In USA

http://www.medicalnewstoday.com/medicalnews.php?newsid=38418

A new prescription option is now available to the more than 50

million Americans who suffer from moderate to moderately severe

chronic pain. Ortho-McNeil, Inc., and Biovail Corporation (NYSE, TSE:

BVF) today announced that once-daily ULTRAM® ER (tramadol HCl)

extended-release tablets are now available by prescription in the

United States.

ULTRAM® ER is the first extended release tramadol product approved in

the U.S. for relief of moderate to moderately severe chronic pain in

adults who require around-the-clock treatment of their pain for an

extended period of time. ULTRAM® ER is available in once-daily dosage

strengths of 100 mg, 200 mg and 300 mg tablets.

The U. S. Food and Drug Administration (FDA) approved ULTRAM® ER in

September 2005 based on clinical and safety data obtained from four

well-controlled clinical trials. More than 3,000 patients have been

treated with ULTRAM® ER in clinical trials.

" Chronic pain affects a large segment of the U.S. population, with an

estimated 45 percent of all Americans seeking care for persistent

pain at least once during their lifetime, " said Dr. Warren A. Katz,

clinical professor of Medicine, University of Pennsylvania School of

Medicine, director of the Osteoporosis Center and Rheumatology at the

Rothman Institute. " ULTRAM® ER is an important new option for

patients who suffer from moderate to moderately severe chronic pain,

and for the physicians who treat them. "

Approximately one-third of all Americans have some element of chronic

pain; many have been living with their pain for more than five years

and experience pain almost six days a week. Up to 700 million work

days are lost in the U.S. each year as a result of pain-related

disabilities. Moreover, chronic pain has a significant economic

impact, with estimated direct and indirect costs in the Unites States

exceeding $100 billion annually.

Tramadol is a non-scheduled centrally-acting synthetic opioid

analgesic that has been used in the treatment of moderate to

moderately severe pain since its introduction in the United States in

1995. ULTRAM® ER uses Biovail's innovative Smartcoat™ technology* to

produce an extended-release tablet that provides appropriate patients

effective pain control over a 24-hour period in a convenient once-

daily form of tramadol. In contrast, patients may need to take

immediate release tramadol tablets every four-six hours for pain

relief.

" The development of a once-daily formulation of tramadol is

indicative of how an innovative drug-delivery technology can overcome

the most difficult formulation enhancement challenges, " said

Squires, Ph.D., chief executive officer of Biovail Corporation.

For more information and full U.S. Prescribing Information about

ULTRAM® ER, please visit www.ULTRAM-ER.com.