Endo Pharmaceuticals to Launch Three New Dosage Strengths of OPANA(R) ER

Mon Mar 3, 2008 7:00am EST

* Reuters is not responsible for the content in this press release.

  CHADDS FORD, PA, Mar 03 (MARKET WIRE) -- 
 Endo Pharmaceuticals Inc., a market leader in pain management and a wholly
owned subsidiary of Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), today
announced
that the U.S. Food and Drug Administration has approved three new dosage
strengths of OPANA(R) ER (oxymorphone HCl) extended-release tablets CII. The
new strengths -- 7.5 mg, 15 mg, and 30 mg -- will be available on April 1,
2008 and will join previously approved OPANA ER dosage strengths of 5 mg, 10
mg, 20 mg, and 40 mg.  An opioid analgesic, OPANA ER is indicated for the
relief of moderate-to-severe pain in patients requiring continuous,
around-the-clockopioid treatment for an extended period of time. (See Important
Safety
Information below.)

    "The addition of three new dosage strengths of OPANA ER, complementing the
currently available strengths, will make it easier for physicians to titrate
patients to the optimal level of pain relief," said David A. Lee, M.D., Ph.D.,
Chief Scientific Officer.  "The new strengths will also facilitate clinicians'
ability to convert patients to OPANA ER from other opioid analgesics to which
they may not have had an adequate clinical response.  Further, the introduction
of
these new strengths underscores Endo's long-term commitment to the OPANA
franchise
and to providing physicians with additional treatment options for their
appropriate
chronicpain patients."

    The approval is based on studies demonstrating the safety and efficacy of
OPANA ER in its four original strengths. Because the new dosages fall between
the available strengths, FDA did not require new safety or efficacy studies.

    About OPANA ER Tablets

    OPANA ER tablets were formulated using oxymorphone hydrochloride, a
semisynthetic, pure u-opioid agonist that had been available previously only as
an
injectable formulation.  The product has been proven to achieve effective relief
in multiple moderate-to-severe chronic pain models, in opioid-naive and
opioid-experienced patients.  All OPANA ER strengths are available by
prescription only.

    Important Safety Information

    OPANA ER is an opioid agonist and Schedule II controlled substance with an
abuse liability similar to morphine.  OPANA ER can be abused in a manner similar
to other opioid agonists, legal or illicit.


 WARNING:

    OPANA ER contains oxymorphone, which is a morphine-like opioid agonist and a
Schedule II controlled substance, with an abuse liability similar to other
opioid analgesics.

    Oxymorphone can be abused in a manner similar to other opioid agonists,
legal or
illicit. This should be considered when prescribing or dispensing OPANA ER in
situations where the physician or pharmacist is concerned about an increased
risk of misuse, abuse, or diversion.

    OPANA ER is an extended-release oral formulation of oxymorphone indicated
for the
management of moderate to severe pain when a continuous, around-the-clock opioid
analgesic is needed for an extended period of time.

    OPANA ER is NOT intended for use as a prn analgesic.

    OPANA ER TABLETS are to be swallowed whole and are not to be broken, chewed,
dissolved, or crushed.  Taking broken, chewed, dissolved, or crushed OPANA
ER TABLETS leads to rapid release and absorption of a potentially fatal
dose of oxymorphone.

    Patients must not consume alcoholic beverages, or prescription or
non-prescription medications containing alcohol, while on OPANA ER
therapy.The co-ingestion of alcohol with OPANA ER may result in increased plasma
levels
and a potentially fatal overdose of oxymorphone.


 OPANA ER is not indicated for pain in
the immediate post-operative period (12-24 hours following surgery), or if pain
is mild or not expected to persist for an extended period of time.

    OPANA ER is contraindicated in patients with a known hypersensitivity to
oxymorphone hydrochloride, morphine analogs such as codeine, or any of the
other ingredients of OPANA ER; in patients with moderate or severe hepatic
impairment or in any situation where opioids are contraindicated.

    Respiratory depression is the chief hazard of OPANA ER, particularly in
elderly or debilitated patients.

    The most common adverse drug reactions (greater than or equal to 10%) in all
clinical trials for OPANA ER were nausea, constipation, dizziness (excluding
vertigo), vomiting, pruritus, somnolence, headache, increased sweating, and
sedation.

    For full prescribing information, visit www.OPANA.com


 Endo's Commitment to Responsible
Pain Management: PROMISE(R)

    Endo is committed to providing healthcare professionals and patients with
safe
and effective opioid analgesic medications and support programs that will
better ensure their appropriate and responsible use. Through extensive
experience
with opioid analgesics and working with the FDA and industry experts, Endo has
developed a comprehensive risk minimization action plan for OPANA ER. 
Evolving from the risk minimization plan is a program to further help reduce
the inherent risk of misuse, abuse and diversion of opioid analgesics: The
Partnership for Responsible Opioid Management through Information, Support, and
Education (PROMISE(R)) initiative contains essential information and guidance to
healthcare professionals so that they can prescribe opioids to patients
responsibly and appropriately. PROMISE includes educational support and
practical
patient management tools. For patients, the program raises the level of
knowledge of
thosesuffering from moderate-to-severe pain and empowers them to manage their
condition with the help of their healthcare professional. More information about
the
PROMISE initiative is available at www.endopromise.com.

    OPANA(R) is a registered trademark of Endo Pharmaceuticals Inc.

    The PROMISE(R) initiative is a registered trademark of Endo
Pharmaceuticals Inc.

    About Endo

    A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., Endo
Pharmaceuticals is a fully integrated specialty pharmaceutical company
withmarket leadership in pain management products. The company researches,
develops,
produces and markets a broad product offering of branded and generic
pharmaceuticals, meeting the needs of healthcare professionals and consumers
alike. More information, including this and past press releases of Endo
Pharmaceuticals Holdings Inc., is available online at www.endo.com.

    Forward-Looking Statements

    This press release contains information that includes or is based on
"forward-looking statements" within the meaning of Section 27A of the
Securities Act of 1933, as amended, or the Securities Act, and Section 21E of
the Securities Exchange Act of 1934, as amended, or the Exchange Act. These
statements, including estimates of future net sales, future expenses, future net
income and future earnings per share, are subject to risks and uncertainties.
Forward-looking statements include the information concerning the company's
possible
or assumed results of operations. Also, statements including words such as
"believes," "expects," "anticipates," "intends," "estimates," "plan," "will,"
"may" or
similar expressions are forward-looking statements. Endo has based these
forward-looking statements on its current expectations and projections about the
growth of its business, its financial performance and the development of its
industry.Because these statements reflect Endo's current views concerning future
events,
these forward-looking statements involve risks and uncertainties. Investors
should note
that many factors could affect Endo's future financial results and could cause
its actual results to differ materially from those expressed in forward-looking
statements contained in this press release. Important factors that could cause
its actual results to differ materially from the expectations reflected in the
forward-lookingstatements in this press release include, but are not limited to:
its ability
to successfully develop, commercialize and market new products; timing and
results
of pre-clinical or clinical trials on new products; its ability to obtain
regulatory approval of any of its pipeline products; competition for the
business
of its branded and generic products, and in connection with its acquisition
of rights to intellectual property assets; market acceptance of its future
products; government regulation of the pharmaceutical industry; its
dependence on a small number of products; its dependence on outside
manufacturers for the manufacture of its products; its dependence on third
parties
to supply raw materials and to provide services for certain core aspects of its
business; new regulatory action or lawsuits relating to its use of narcotics
in most of its core products; its exposure to product liability claims and
product recalls and the possibility that the company may not be able to
adequately insure itself; its ability to protect its proprietary technology; the
successful efforts of manufacturers of branded pharmaceuticals to use litigation
andlegislative and regulatory efforts to limit the use of generics and
certainother products; its ability to successfully implement its acquisition and
in-licensing strategy; regulatory or other limits on the availability of
controlled substances that constitute the active ingredients of some of
itsproducts and products in development; the availability of third-party
reimbursement
for its products; the outcome of any pending or future litigation or claims by
the government; its dependence on sales to a limited number of large
pharmacy chains and wholesale drug distributors for a large portion of its
total net sales; significant litigation expenses to defend or assert patent
infringement claims; any interruption or failure by its suppliers,
distributors and collaboration partners to meet their obligations pursuant to
various agreements with Endo; a determination by a regulatory agency that
Endo is engaging in inappropriate sales or marketing activities, including
promoting the "off-label" use of its products; existing suppliers become
unavailable or lose their regulatory status as an approved source, causing
an inability to obtain required components, raw materials or products on a
timely basis or at commercially reasonable prices; the loss of branded product
exclusivity periods and related intellectual property; and its exposure to
securities that are subject to market risk.

    The company does not undertake any obligation to update its
forward-lookingstatements after the date of this Report for any reason, even if
new
information becomes available or other events occur in the future. You are
advised, however, to consult any further disclosures we make on related subjects
in our 10-K, 10-Q and 8-K reports to the Securities and Exchange Commission (or
SEC). Also note that Endo provides the preceding cautionary discussion of risks,
uncertainties and possibly inaccurate assumptions relevant to its business.
These are
factors that, individually or in the aggregate, the company believes could
cause its actual results to differ materially from expected and historical
results. Endo notes these factors for investors as permitted by the Private
Securities Litigation Reform Act of 1995. You should understand that it is
not possible to predict or identify all such factors. Consequently, you
should not consider the preceding to be a complete discussion of all
potential risks or uncertainties.

    



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