Healthcare Industry News: Penwest Pharmaceuticals
News Release - July 24, 2006
Endo Announces Commercial Availability of Opana(R) ER (oxymorphone HCl) Extended-Release and Opana(R) (oxymorphone HCl) Immediate-Release Tablets CIIEndo Also Launches New Comprehensive PROMISE(TM) Initiative to Support Appropriate and Responsible Opioid Use
CHADDS FORD, Pa., July 24 (HSMN NewsFeed) -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP ), has announced the commercial availability of OpanaŽ ER and OpanaŽ tablets. Endo has begun shipments to its customers and is instituting a wholesale and retail stocking program to ensure these products are distributed to retail pharmacies across the U.S. over the next several weeks. OpanaŽ ER and OpanaŽ are extended-release and immediate-release formulations of oxymorphone hydrochloride (HCl) that were approved by the U.S. Food and Drug Administration on June 22, 2006.
A new oral extended-release opioid analgesic treatment option for patients, OpanaŽ 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. OpanaŽ ER is not intended to be used on an as-needed basis. This is the first time oxymorphone will be available in an oral, extended-release formulation and will be available in 5mg, 10mg, 20mg and 40mg tablets. OpanaŽ (the immediate release version) is indicated for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate and will be available in 5mg and 10mg tablets. Both OpanaŽ ER and OpanaŽ are available by prescription only.
This fall, Endo also plans to re-launch its injectable formulation of oxymorphone in the hospital setting under the new trade name. This will complete the "continuum of care" for OpanaŽ by making it available in parenteral, short- and long- acting oral formulations.
"We are delighted to be able to provide physicians and patients with this new, much-needed option for patients with moderate-to-severe pain, and particularly for patients who have not found satisfaction with their current opioid treatment," said Peter A. Lankau, President and Chief Executive Officer, "As a leader in pain management, we also take very seriously our responsibility of helping physicians and caregivers appropriately manage pain. We are confident that Endo's PROMISE(TM) initiative, combined with our Risk Minimization Action Plan developed in conjunction with the FDA and other outside experts, will effectively minimize the inherent risks of opioid misuse, abuse and diversion through comprehensive education and support programs for both patients and physicians."
Endo's Commitment to Responsible Pain Management: PROMISE(TM)
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 OpanaŽ ER and OpanaŽ. Evolving from the risk minimization plan is a new initiative 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(TM)). The PROMISE(TM) initiative contains essential information and guidance to healthcare professionals so that they can prescribe opioids to patients responsibly and appropriately. PROMISE(TM) 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(TM) initiative is available at www.endopromise.com .
About Opana ER and OpanaŽ Tablets
OpanaŽ ER and OpanaŽ tablets were formulated using oxymorphone hydrochloride, a semisynthetic, pure microgram-opioid agonist that had been available previously only as an injectable formulation. Both products have been proven to achieve effective relief in multiple moderate-to-severe pain models, in opioid-naive and opioid-experienced patients.
OpanaŽ ER's clinical profile has demonstrated that it can be dosed consistently on a twice-daily basis and is well-tolerated when titrated effectively. OpanaŽ ER has also shown maintenance of effective pain control at a stable dose over the three-month period of the pivotal clinical trials, which the company believes highlights the durability of its analgesic effect. OpanaŽ ER utilizes a patented delivery system that was specifically developed to provide continuous delivery of medication over a 12-hour period, helping patients maintain a steady level of pain relief. Experts agree that patients suffering from moderate-to-severe chronic pain which is present much or all of the day need around-the-clock coverage with an analgesic agent to sustain pain relief.
OpanaŽ ER has been studied in a wide range of chronic pain conditions, including low back pain, osteoarthritis pain, and cancer pain. Endo developed OpanaŽ ER using Penwest Pharmaceuticals' proprietary time-release technology, TIMERxŽ.
OpanaŽ has been studied in multiple post-operative pain models, including orthopedic and abdominal procedures. Immediate-release OpanaŽ is a proprietary product developed by Endo.
Important Safety Information
OpanaŽ ER and OpanaŽ are opioid agonists and Schedule II controlled substances with an abuse liability similar to morphine. OpanaŽ ER and OpanaŽ 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.
OpanaŽ 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.
OpanaŽ ER and OpanaŽ are contraindicated in patients with a known hypersensitivity to oxymorphone hydrochloride, morphine analogs such as codeine, or any of the other ingredients of OpanaŽ ER and OpanaŽ; in patients with moderate or severe hepatic impairment or in any situation where opioids are contraindicated.
Respiratory depression is the chief hazard of OpanaŽ ER and OpanaŽ, particularly in elderly or debilitated patients.
The most common adverse drug reactions (greater than or equal to 10%) in clinical trials for OpanaŽ ER were nausea, constipation, dizziness, vomiting, pruritus, somnolence, headache, increased sweating, and sedation. The most common adverse drug reactions (greater than or equal to 10%) reported in clinical trials for OpanaŽ were nausea and pyrexia.
For full prescribing information, visit www.opana.com .
A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., Endo Pharmaceuticals Inc. 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 forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on management's beliefs and assumptions, current expectations, estimates and projections. Statements that are not historical facts, including statements which are preceded by, followed by, or that include, the words "believes," "anticipates," "plans," "expects" or similar expressions and statements are forward-looking statements. Endo's estimated or anticipated future results, product performance or other non- historical facts are forward-looking and reflect Endo's current perspective on existing trends and information. Many of the factors that will determine the Company's future results are beyond the ability of the Company to control or predict. These statements are subject to risks and uncertainties and, therefore, actual results may differ materially from those expressed or implied by these forward-looking statements. The reader should not rely on any forward-looking statement. The Company undertakes no obligation to update any forward-looking statements whether as a result of new information, future events or otherwise. Several important factors, in addition to the specific factors discussed in connection with these forward-looking statements individually, could affect the future results of Endo and could cause those results to differ materially from those expressed in the forward-looking statements contained in this press release. Important factors that may affect future results include, but are not limited to: market acceptance of the Company's products and the impact of competitive products and pricing; dependence on sole source suppliers; the success of the Company's product development activities and the timeliness with which regulatory authorizations and product launches may be achieved; successful compliance with extensive, costly, complex and evolving governmental regulations and restrictions; the availability on commercially reasonable terms of raw materials and other third party manufactured products; exposure to product liability and other lawsuits and contingencies; dependence on third party suppliers, distributors and collaboration partners; the ability to timely and cost effectively integrate acquisitions; uncertainty associated with pre- clinical studies and clinical trials and regulatory approval; uncertainty of market acceptance of new products; the difficulty of predicting FDA approvals; risks with respect to technology and product development; the effect of competing products and prices; uncertainties regarding intellectual property protection; uncertainties as to the outcome of litigation; changes in operating results; impact of competitive products and pricing; product development; changes in laws and regulations; customer demand; possible future litigation; availability of future financing and reimbursement policies of government and private health insurers and others; and other risks and uncertainties detailed in Endo's filings with the Securities and Exchange Commission, including its Registration Statement on Form S-3 filed with the SEC on March 21, 2006. Readers should evaluate any statement in light of these important factors.
Source: Endo Pharmaceuticals
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