ExalgoTreatment for Pain in Opioid Tolerant Patients
Update: Exalgo Now FDA Approved - March 1, 2010
FDA Advisory Committee Reviews Exalgo
FDA Advisory Committee Hears Presentations and Public Comment on Exalgo Extended-Release Tablets
ST. LOUIS--(BUSINESS WIRE)--Sep 23, 2009 - Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that it presented information to members of a U.S. Food and Drug Administration (FDA) Advisory Committee on the New Drug Application and proposed Risk Evaluation and Mitigation Strategy (REMS) program for Exalgo (hydromorphone HCl extended release) tablets, an opioid formulation. At a meeting held today in Gaithersburg, Md., committee members also heard public comments about the analgesic. Covidien will now await FDA's decision on Exalgo approval.
"We are pleased that the committee endorsed the REMS program as proposed by Covidien and Neuromed," said Timothy R. Wright, President, Pharmaceuticals, Covidien. "The committee has asked us to look at the possibility of a phased rollout, and we look forward to discussing this input with the agency and other pain management experts."
If approved, Exalgo will offer around-the-clock relief for opioid tolerant patients with moderate to severe pain for an extended period of time. Exalgo utilizes a unique, extended-release technology that allows for once-a-day dosing. This technology is the OROS® Push-Pull™ oral osmotic delivery system that is designed to release the hydromorphone at a consistent rate. This proven technology has been used for 20 years in 13 other products. For physicians, Exalgo provides a well-known therapy used in the treatment of chronic pain for more than 80 years – hydromorphone HCl, in an extended-release formulation.
During the meeting, information was provided on Exalgo Alliance – the proposed REMS for Exalgo, which is a comprehensive program that combines education, controlled access and ongoing surveillance. Combined with Exalgo's proposed labeling, Exalgo Alliance will help ensure the appropriate access, prescribing, dispensing and use of Exalgo.
On May 22, 2009, a Complete Response was submitted to an Approvable Letter for Exalgo that was issued by the FDA in October 2000. The FDA assigned a Prescription Drug User Fee Act date of November 22, 2009, to complete its review of the application. The meeting held today is another step in the approval process.
In June 2009, Covidien, through its Mallinckrodt Inc. subsidiary, acquired the licensing rights to Exalgo Tablets from Neuromed Development Inc., a subsidiary of Neuromed Pharmaceuticals Ltd. Neuromed acquired the U.S. marketing rights to Exalgo from ALZA Corporation in April 2007.
Under the agreement, Covidien is responsible for all commercialization activities for Exalgo in the U.S., including marketing, sales and all regulatory filings post-FDA approval. Neuromed completed the clinical development and oversees the regulatory approval process. For a specified period, ALZA will remain responsible for the manufacturing, packaging and supply of Exalgo. The intellectual property covering the hydromorphone formulation under review is owned by ALZA.
Exalgo is an investigational drug and has not been approved by the FDA. Exalgo has been studied in more than 2,000 pain patients in clinical trials. The most common adverse events seen in clinical trials to date were opioid-related events of constipation, nausea, somnolence, headache, vomiting and dizziness. Respiratory depression is the most important hazard of opioid preparations including Exalgo.
Exalgo is a trademark of Neuromed Development Inc.
OROS® and Push-Pull™ are trademarks of ALZA Corporation.
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2008 revenue of $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about its business.
Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or Company actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, our ability to effectively introduce and market new products or keep pace with advances in technology, the reimbursement practices of a small number of large public and private insurers, cost-containment efforts of customers, purchasing groups, third-party payers and governmental organizations, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations, manufacturing or supply chain problems or disruptions, rising commodity costs, recalls or safety alerts and negative publicity relating to Covidien or its products, product liability losses and other litigation liability, including legacy Tyco-related litigation, divestitures of some of our businesses or product lines, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, competition, risks associated with doing business outside of the United States, foreign currency exchange rates, issues related to our existing material weakness in accounting for income taxes or potential environmental liabilities. These and other factors are identified and described in more detail in our filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.
Stephen Littlejohn, 314-654-6595
Vice President, Communications
Bruce Farmer, 508-452-4372
Coleman Lannum, CFA, 508-452-4343
Brian Nameth, 508-452-4363
Posted: September 2009
- FDA Approves Mallinckrodt's Exalgo (hydromorphone HCl) Extended-Release Tablets 32 mg (CII) for Opioid-Tolerant Patients with Moderate-to-Severe Chronic Pain - August 27, 2012
- FDA Approves Exaglo (hydromorphone HCl) Extended-Release Tablets - March 2, 2010
- CombinatoRx Announces Extension of Exalgo Extended-Release Tablets PDUFA Date to March 1, 2010 - February 17, 2010
- Neuromed Receives FDA Feedback on New Drug Application for Exalgo Extended-Release Tablets - November 16, 2009