WILMINGTON, N.C., Feb. 13 /PRNewswire-FirstCall/ -- aaiPharma Inc.
(Nasdaq: AAII) announced today that it has received approval of a new
methadone label from the U.S. Food and Drug Administration for its
parenterally administered methadone product (formerly branded as Dolophine(R)
Injection).
"Methadone hydrochloride injection is an important product for patients in
moderate to severe pain requiring intrathecal, intravenous, subcutaneous or
intramuscular treatment," commented Dr. Philip S. Tabbiner, President and
Chief Executive Officer of aaiPharma. "We are pleased with the collaborative
effort with the FDA that led to the labeling we received and are ready to meet
the patient need for this medically necessary pain management treatment."
aaiPharma offers physicians and patients one of the most comprehensive
portfolios of pain products. Currently, the Company markets the Darvon(R) and
Darvocet A500(TM) family of pain management products for the treatment of
mild-to-moderate pain, and is developing a pipeline of line extensions to this
brand franchise as well as novel products for the treatment of pain. These
products, coupled with the recently acquired Oramorph(R) SR, Roxicodone(R),
Roxanol(TM) and Duraclon(R) products, will provide physicians with treatment
options across a broad spectrum of prescription pain relief.
About Methadone Hydrochloride Injection
This product is a parenterally administered methadone product indicated
for the treatment of moderate to severe pain not responsive to non-narcotic
analgesics, and for use in temporary treatment of opioid dependence in
patients unable to take oral medication.
Methadone hydrochloride injection is contraindicated in patients with a
known hypersensitivity to methadone or any situation in which opioids are
contra-indicated, e.g., patients with respiratory depression, acute bronchial
asthma or hypercarbia. Methdaone should be administered with particular
caution to patients already at risk for development of prolonged QT interval
(e.g., cardiac hypertrophy, concomitant diuretic use, hypokalemia,
hypomagnesemia). Careful monitoring is recommended when using methadone in
patients with a history of cardiac conduction abnormalities, those taking
medications affecting cardiac conduction, and in other cases where history or
physical exam suggest an increased risk of dysrhythmia. Methadone
hydrochloride, a narcotic, is a Schedule II controlled substance under the
Federal Controlled Substances Act.
About aaiPharma
aaiPharma Inc. is a leading, science-based pharmaceutical company focused
on pain management, with corporate headquarters in Wilmington, North Carolina.
With more than 24 years of drug development expertise, the Company is focused
on developing, acquiring, and marketing well-known, branded medicines in its
targeted therapeutic areas. aaiPharma 's development efforts are focused on
developing improved medicines from established molecules through its
significant research and development capabilities. For more information on
the Company, including its product development organization AAI Development
Services, please visit aaiPharma's website at http://www.aaipharma.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 the
statements pertaining to the Company's future plans and expectations as to
methadone hydrochloride injection, the potential medical and commercial
significance, opportunities and interest in the methadone hydrochloride
injection product and the recently acquired pain products identified above,
the Company's research and development activities, and 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 to the Company's ability to timely and
successfully meet such plans, and to successfully acquire, finance, develop,
improve, obtain timely regulatory approval for, extend product life cycles of,
conduct successful research on, market, and sell, on a commercially profitable
basis, pharmaceutical products (including methadone hydrochloride injection
and the newly acquired pain products identified above); to obtain, use,
enforce, defend and license valid and commercially valuable patents; to obtain
and enforce existing and future contracts with major pharmaceutical companies;
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, August 14, 2003 (including its Exhibit 99.1) and November 14,
2003; its Form 8-Ks; and its other periodic filings.
Darvocet A500(tm) and Roxanol(tm) are trademarks, and Roxicodone(r) and
Oramorph(r) SR are registered trademarks, owned by aaiPharma Inc. Darvon(r)
is a registered trademark owned by aaiPharma LLC. Duraclon(r) is a
registered trademark of Fujisawa USA, Inc., licensed to 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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