Max
10-14-2003, 06:21 PM
New Convenient Option Provides Continuous Pain Relief After Surgery
Tuesday October 14, 6:30 pm ET
Results Presented at the American Society of Anesthesiologists Annual Meeting Show Novel Single-Injection Epidural Delivery System Offers a Convenient Alternative to Existing Pain Relief
PHILADELPHIA, Oct. 14 /PRNewswire/ -- New study results presented today at the annual meeting of the American Society of Anesthesiologists show that a late-stage clinical candidate for pain relief after surgery provided extended pain relief for 48 hours following hip replacement. The multi-center study, investigating a potential new pain management option, was led by Eugene Viscusi, M.D., director of the Acute Pain Management Service at Thomas Jefferson University Hospital, Philadelphia.
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Pain management following surgery remains a challenge. The only currently approved method of epidural pain management is via an in-dwelling catheter, which is inserted into an area surrounding the spinal cord. This delivery method is often inconvenient for patients, because it limits their movement, and also poses many challenges to surgeons and anesthesiologists. Due to an increased risk of bleeding problems, patients taking blood-thinning medications are not normally suitable candidates for a medication delivered through a catheter. Along with these potential complications, epidurals are labor intensive and costly for the care provider. Thus, surgeons and anesthesiologists are forced to use alternative analgesic delivery methods, such as patient-controlled pumps mounted to an I.V. pole, which can on occasion malfunction.
"Results from our study suggest that the new candidate, called DepoMorphine(TM), has the potential to become a valuable new option for managing post-operative pain, because it is released slowly over time with only one injection. The introduction of this agent into the arsenal of post-operative pain management may be preferable because it eliminates the risks and burdens of the catheter while providing continuous pain relief," stressed Dr. Viscusi, lead investigator and director, Acute Pain Management, Jefferson Medical College of Thomas Jefferson University.
Approximately 120,000 hip operations are performed each year in the United States with the purpose of reconstructing or replacing painfully degenerated hip joints and, ultimately, restoring mobility for patients. Post-operative pain is a significant problem for this and other segments of the surgical population, affecting up to 75 percent of all hospitalized patients. Overall, an estimated 40 million inpatient surgical procedures are performed annually in the United States. In addition to hip replacement surgery, these include major surgery, lower extremities orthopedic surgery and lower abdominal surgery, many of which could be candidates for DepoMorphine.
DepoMorphine is an injectable formulation of morphine sulfate, formulated with a unique lipid vesicular delivery technology, DepoFoam(TM), which is designed to release the analgesic over an extended period of time. In studies, it is administered as a single injection via epidural needle or catheter before surgery.
"Data from our study suggest that the use of DepoMorphine is both safe and effective. Potential benefits may include shorter hospital stays, reduce the time health care providers spend attending to epidural pumps and catheters, allow more time for direct patient care, and improve overall patient outcomes," noted Dr. Viscusi.
Study Results
To assess the efficacy of DepoMorphine in the management of post-operative pain following hip surgery, a randomized double-blind, placebo-controlled, multi-center study was conducted. The study gauged the reduction in the use of patient-controlled intravenous (IV) fentanyl following a single epidural administration of DepoMorphine compared to a saline, placebo group. The use of DepoMorphine led to a highly significant reduction in fentanyl use versus placebo from 0 to 48 hours (p< .0001). Furthermore, a significant number of these patients did not require any additional analgesia for two days immediately following the surgery. Patient and physician satisfaction scores of pain control showed improved rankings with DepoMorphine.
At all doses in this study, DepoMorphine was well tolerated with an adverse event profile typical of opioids, including nausea, itching, fever, vomiting and respiratory depression.
DepoMorphine is currently under review by the U.S. Food and Drug Administration for marketing in the United States for the treatment of mild- to-severe post-operative pain. In July, SkyePharma, Inc. submitted a New Drug Application to the FDA for marketing approval of DepoMorphine. The NDA is based on data from an extensive development program that included clinical trials involving nearly 1,000 patients undergoing major surgery, including lower extremity orthopedic surgery and lower abdominal surgery. Endo Pharmaceuticals owns the exclusive license to market and distribute DepoMorphine in the U.S. and Canada.
Jefferson Hospital has major programs for cancer treatment, heart disease, high-risk childbirth, genetics, radiology, neuroscience, orthopaedics, digestive diseases and many other areas of medicine and surgery. It is one of only a few hospitals in the United States that is both a Level I Trauma Center and a federally designated regional spinal cord injury center. Jefferson's Kimmel Cancer Center is designated as a clinical cancer center by the National Cancer Institute. In addition, Jefferson University Hospital and the hospitals of the Jefferson Cancer Network provide free screenings for breast, skin and prostate cancers. There are a number of free support programs available.
U.S. News and World Report has consistently ranked many of Jefferson's services as among the best in the nation. These include rehabilitation, cardiology/cardiac surgery, orthopaedics, digestive disorders (gastroenterology), geriatrics, gynecology, neurology and neurosurgery, which are both based at Jefferson Hospital for Neuroscience, otolaryngology -- head and neck surgery, and urology. Jefferson physicians have been named among the best doctors by Philadelphia Magazine and by Best Doctors in America.
Jefferson University Hospital has also been listed by Solucient (formerly HCIA-Sachs Institute) as one of the top 100 hospitals in the United States and the Philadelphia region, as well as one of the top major teaching hospitals in the nation. Solucient also cited Jefferson as being one of the top 100 hospitals in the nation for:
* Providing cost-effective stroke care
* For having one of the top performing intensive care unit (ICU) services
in the nation.
In addition, Jefferson University Hospital has been awarded the Consumer Choice Award for six years in a row by the National Research Corporation (NRC), for being an innovator and leader in health care in Philadelphia.
--------------------------------------------------------------------------------
Source: Thomas Jefferson University Hospital
Tuesday October 14, 6:30 pm ET
Results Presented at the American Society of Anesthesiologists Annual Meeting Show Novel Single-Injection Epidural Delivery System Offers a Convenient Alternative to Existing Pain Relief
PHILADELPHIA, Oct. 14 /PRNewswire/ -- New study results presented today at the annual meeting of the American Society of Anesthesiologists show that a late-stage clinical candidate for pain relief after surgery provided extended pain relief for 48 hours following hip replacement. The multi-center study, investigating a potential new pain management option, was led by Eugene Viscusi, M.D., director of the Acute Pain Management Service at Thomas Jefferson University Hospital, Philadelphia.
ADVERTISEMENT
Pain management following surgery remains a challenge. The only currently approved method of epidural pain management is via an in-dwelling catheter, which is inserted into an area surrounding the spinal cord. This delivery method is often inconvenient for patients, because it limits their movement, and also poses many challenges to surgeons and anesthesiologists. Due to an increased risk of bleeding problems, patients taking blood-thinning medications are not normally suitable candidates for a medication delivered through a catheter. Along with these potential complications, epidurals are labor intensive and costly for the care provider. Thus, surgeons and anesthesiologists are forced to use alternative analgesic delivery methods, such as patient-controlled pumps mounted to an I.V. pole, which can on occasion malfunction.
"Results from our study suggest that the new candidate, called DepoMorphine(TM), has the potential to become a valuable new option for managing post-operative pain, because it is released slowly over time with only one injection. The introduction of this agent into the arsenal of post-operative pain management may be preferable because it eliminates the risks and burdens of the catheter while providing continuous pain relief," stressed Dr. Viscusi, lead investigator and director, Acute Pain Management, Jefferson Medical College of Thomas Jefferson University.
Approximately 120,000 hip operations are performed each year in the United States with the purpose of reconstructing or replacing painfully degenerated hip joints and, ultimately, restoring mobility for patients. Post-operative pain is a significant problem for this and other segments of the surgical population, affecting up to 75 percent of all hospitalized patients. Overall, an estimated 40 million inpatient surgical procedures are performed annually in the United States. In addition to hip replacement surgery, these include major surgery, lower extremities orthopedic surgery and lower abdominal surgery, many of which could be candidates for DepoMorphine.
DepoMorphine is an injectable formulation of morphine sulfate, formulated with a unique lipid vesicular delivery technology, DepoFoam(TM), which is designed to release the analgesic over an extended period of time. In studies, it is administered as a single injection via epidural needle or catheter before surgery.
"Data from our study suggest that the use of DepoMorphine is both safe and effective. Potential benefits may include shorter hospital stays, reduce the time health care providers spend attending to epidural pumps and catheters, allow more time for direct patient care, and improve overall patient outcomes," noted Dr. Viscusi.
Study Results
To assess the efficacy of DepoMorphine in the management of post-operative pain following hip surgery, a randomized double-blind, placebo-controlled, multi-center study was conducted. The study gauged the reduction in the use of patient-controlled intravenous (IV) fentanyl following a single epidural administration of DepoMorphine compared to a saline, placebo group. The use of DepoMorphine led to a highly significant reduction in fentanyl use versus placebo from 0 to 48 hours (p< .0001). Furthermore, a significant number of these patients did not require any additional analgesia for two days immediately following the surgery. Patient and physician satisfaction scores of pain control showed improved rankings with DepoMorphine.
At all doses in this study, DepoMorphine was well tolerated with an adverse event profile typical of opioids, including nausea, itching, fever, vomiting and respiratory depression.
DepoMorphine is currently under review by the U.S. Food and Drug Administration for marketing in the United States for the treatment of mild- to-severe post-operative pain. In July, SkyePharma, Inc. submitted a New Drug Application to the FDA for marketing approval of DepoMorphine. The NDA is based on data from an extensive development program that included clinical trials involving nearly 1,000 patients undergoing major surgery, including lower extremity orthopedic surgery and lower abdominal surgery. Endo Pharmaceuticals owns the exclusive license to market and distribute DepoMorphine in the U.S. and Canada.
Jefferson Hospital has major programs for cancer treatment, heart disease, high-risk childbirth, genetics, radiology, neuroscience, orthopaedics, digestive diseases and many other areas of medicine and surgery. It is one of only a few hospitals in the United States that is both a Level I Trauma Center and a federally designated regional spinal cord injury center. Jefferson's Kimmel Cancer Center is designated as a clinical cancer center by the National Cancer Institute. In addition, Jefferson University Hospital and the hospitals of the Jefferson Cancer Network provide free screenings for breast, skin and prostate cancers. There are a number of free support programs available.
U.S. News and World Report has consistently ranked many of Jefferson's services as among the best in the nation. These include rehabilitation, cardiology/cardiac surgery, orthopaedics, digestive disorders (gastroenterology), geriatrics, gynecology, neurology and neurosurgery, which are both based at Jefferson Hospital for Neuroscience, otolaryngology -- head and neck surgery, and urology. Jefferson physicians have been named among the best doctors by Philadelphia Magazine and by Best Doctors in America.
Jefferson University Hospital has also been listed by Solucient (formerly HCIA-Sachs Institute) as one of the top 100 hospitals in the United States and the Philadelphia region, as well as one of the top major teaching hospitals in the nation. Solucient also cited Jefferson as being one of the top 100 hospitals in the nation for:
* Providing cost-effective stroke care
* For having one of the top performing intensive care unit (ICU) services
in the nation.
In addition, Jefferson University Hospital has been awarded the Consumer Choice Award for six years in a row by the National Research Corporation (NRC), for being an innovator and leader in health care in Philadelphia.
--------------------------------------------------------------------------------
Source: Thomas Jefferson University Hospital