SOURCE: Endo Pharmaceuticals
March 03, 2008 07:00 ET
Endo Pharmaceuticals to Launch Three New Dosage Strengths of OPANA® ER
Intermediate Strengths Provide Additional Dosing Options for Physicians Treating Patients With Moderate-to-Severe Chronic Pain
CHADDS FORD, PA--(Marketwire - March 3, 2008) - 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® 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-clock
opioid treatment for an extended period of time. (See Important Safety
"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 chronic
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
About OPANA ER Tablets
OPANA ER tablets were formulated using oxymorphone hydrochloride, a
semisynthetic, pure µ-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-naïve 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.
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®
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®) 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 those
suffering 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® is a registered trademark of Endo Pharmaceuticals Inc.
The PROMISE® initiative is a registered trademark of Endo Pharmaceuticals
A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., Endo
Pharmaceuticals is a fully integrated specialty pharmaceutical company with
market 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.
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-looking
statements 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 and
legislative and regulatory efforts to limit the use of generics and certain
other 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 its
products 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
The company does not undertake any obligation to update its forward-looking
statements 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