Field Sales Force of Nearly 250 Representatives to Promote Product
WILMINGTON, N.C., Oct. 7 /PRNewswire-FirstCall/ -- aaiPharma Inc.
(Nasdaq: AAII) announced today that it has commenced nationwide marketing of
Darvocet A500(TM) (propoxyphene napsylate and acetaminophen) for the
management of mild to moderate pain. Darvocet A500(TM) is the only
propoxyphene napsylate/acetaminophen combination product that contains the
same strength of propoxyphene napsylate found in Darvocet-N(R) 100, the
market-leading presentation, with the safety benefit of a lower dose of
acetaminophen.
"The availability of Darvocet A500(TM) gives clinicians greater
flexibility in maintaining optimum control of mild to moderate pain while
widening the margin of safety for the many patients who supplement their
analgesia by self-medicating with over-the-counter acetaminophen," said Dr.
Chris Edwards, Assistant Clinical Professor of Medicine at Florida State
University College of Medicine, Orlando Campus and Internal Medicine Physician
with Central Medical Group in Orlando. "This new formulation with lower
acetaminophen content is responsive to the realities of clinical practice and
enhances a cornerstone of pain management."
Due to safety concerns about the potential for liver toxicity from large
doses of acetaminophen, the U.S. Food and Drug Administration (FDA)
established a 4,000 mg maximum daily dose for adults. Containing only 500 mg
of acetaminophen, compared to 650 mg in Darvocet-N(R) 100, new Darvocet
A500(TM), taken at the daily dose, provides 1,000 mg less acetaminophen than
the FDA limit. Because many patients continue taking over-the-counter pain
relievers and sleep aids containing acetaminophen in addition to a
prescription pain reliever, Darvocet A500(TM) reduces the likelihood of
exceeding the recommended daily limit for acetaminophen when taken up to six
times per day, without sacrificing analgesic efficacy.
aaiPharma received FDA approval of Darvocet A500(TM) on September 10,
2003. aaiPharma's field sales force will be supported by additional sales
resources from Athlon Pharmaceuticals, from whom aaiPharma acquired the
product, resulting in a field sales force of nearly 250 representatives
promoting Darvocet A500(TM).
"Darvocet A500(TM) is the first new product to be nationally launched and
detailed by aaiPharma," said Dr. Philip S. Tabbiner, President and CEO of
aaiPharma. "We have allocated substantial promotional resources to this
launch to ensure that professionals are aware of this unique alternative in
pain management and to maximize the contribution of Darvocet A500(TM) to our
success."
A mild opioid analgesic, Darvocet A500(TM) fills an important step in the
middle of the continuum of pain management, bridging the pain relief gap
between prescription non-steroidal anti-inflammatory (NSAID) products and
stronger opioid analgesics such as hydrocodone. Formalized by the World
Health Organization into a three-step Pain Ladder, this standard algorithm
begins with over-the-counter drugs like non-prescription strength aspirin and
acetaminophen, and adds classes of agents at each stage as pain management
becomes more difficult, up to Schedule II opioids, such as morphine, for
severe pain.
Specifically, propoxyphene napsylate (100 mg), the active opioid
ingredient in Darvocet A500(TM), has been shown to produce approximately
equivalent analgesia to 60 mg of codeine, the highest prescription strength of
that stronger, more addictive opioid. As such, propoxyphene provides an
important intermediate therapeutic step between non-opioids and adjuncts
(over-the-counter drugs and NSAIDs) and stronger opioids (schedule CIII and
CII narcotics). The combination of propoxyphene and acetaminophen has been
shown to produce greater pain relief than either agent alone.
Darvocet A500(TM) is not available without a prescription. Patients
should use their medication as directed by their healthcare provider.
Physicians should not prescribe propoxyphene for patients who are suicidal or
addiction-prone. Please see Full Prescribing Information at
http://www.darvocetA500.com for additional information.
About aaiPharma
aaiPharma Inc. is a leading, science-based specialty pharmaceutical
company with corporate headquarters in Wilmington, North Carolina. With more
than 23 years of drug development expertise and a proven sales and marketing
track record, the Company is focused on acquiring, improving and marketing
well-known, branded medicines in pain management, critical care and
gastroenterology. In addition to its branded product portfolio and robust
pipeline, aaiPharma continues to offer comprehensive drug development services
to the pharmaceutical, biotechnology, generic and device industries through
its services division, AAI Development Services. For more information, please
visit aaiPharma's website at http://www.aaipharma.com. For more information on
Darvocet A500(TM), please visit http://www.darvocetA500.com.
Forward Looking Statements
Information in this press release contains certain "forward-looking
statements" within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Securities and Exchange Act of 1934, including
statements concerning the future medical and commercial significance of, and
the market opportunity for, the approved Darvocet A500(TM) product, the
uniqueness of the product and its dose combination, the future use of
aaiPharma's and Athlon's sales force to promote the product, and the future
development (including through the use of our research and drug development
capabilities), regulatory approval, commercialization and growth of products
in the Company's pipeline and of its product portfolio. The "forward-looking
statements" herein involve risks and uncertainties that could cause actual
results to differ materially, including, without limitation, risks and
uncertainties pertaining aaiPharma's ability to timely and successfully
develop, improve, obtain timely regulatory approval for, and profitably sell
pharmaceutical products (including Darvocet A500(TM)); to obtain, use,
enforce, defend and license valid and commercially valuable patents; to obtain
and enforce existing and future contracts with major pharmaceutical companies
for significant royalties and other consideration; and on the commercial
success of the contemplated products. Additional factors that may cause the
actual results to differ materially are discussed in aaiPharma's recent
filings with the Securities and Exchange Commission, including, but not
limited to, its Annual Report on Form 10-K filed on March 28, 2003, including
its Exhibit 99.1 and other exhibits; its Forms 10-Q filed on May 15, 2003 and
August 14, 2003, its Form 8-Ks; and its other periodic filings.
Darvocet A500(TM) is a trademark and Darvocet-N(R) is a registered
trademark, owned by aaiPharma Inc.
SOURCE aaiPharma Inc.
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Related links:
http://www.aaipharma.com
CONTACT:
media, Andrea L. Johnston, Vice President,
Corporate Communications, +1-910-254-7340, or investors, James B.
Sloan, Jr., Senior Vice President, Corporate Finance,
+1-910-254-7690, both of aaiPharma Inc.
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