New single-shot epidural DepoDur(TM) the next generation of pain relief after surgery
CHADDS FORD, Pa., December 6, 2004 – Beginning today, Endo Pharmaceuticals Inc. will initiate commercial shipments of the first and only single-dose epidural injection that can provide up to 48 hours of pain control to help ease pain for people undergoing major surgery in the United States. Every year, millions of Americans undergo painful procedures such as Cesarean sections, hip and knee replacements, and abdominal surgery. The many methods of relieving pain after such procedures include some that require catheters or IV (intravenous) lines. DepoDur™ (morphine sulfate extended-release liposome injection) is delivered as a single epidural shot using the innovative DepoFoam™ technology that allows the painkiller to be released into the epidural space over time. This may reduce the need for external tubes and pumps that are common with other forms of pain management following major surgery.
"DepoDur™ is good news for people having major surgery and is also a welcome change for physicians," said Gavin Martin, M.D., assistant clinical professor of anesthesiology, Duke University Medical Center. "With DepoDurTM, we can provide effective pain control for patients with fewer cumbersome devices, possibly improving the hospital experience and accelerating their recovery."
Unlike common formulations of morphine that are administered epidurally, DepoDur™ does not require an indwelling catheter for continuous pain relief. Indwelling catheters are tubes placed in a patient's spine to deliver pain medicine. Such catheters can make it difficult for patients to move around after surgery, can increase the risk of infection and can limit options for administration of anticoagulant (blood thinning) therapy. Another common method to relieve pain after surgery is by delivering the pain medication intravenously through patient-controlled analgesia pumps (IV PCA). Unfortunately, with IV PCA there can be equipment malfunction or patient error, leading to under- or over-delivery of medication and variable pain control. A recent meta-analysis reported in the Journal of the American Medical Association, encompassing three decades of research, showed that epidural analgesia provides significantly better postoperative pain control compared to parenteral opioids.
"Pain control after surgery is an important factor contributing to a fast recovery," said Martin. "In fact, research shows that patients whose post-surgery pain is managed properly may have less complicated rehabilitation periods and fewer chronic pain problems than those whose pain is not managed properly."
DepoDurTM: The Next Generation of Pain Relief after Surgery
Marketed by Endo Pharmaceuticals Inc., DepoDur™ is the first single-dose extended-release epidural formulation of morphine sulfate approved by the U.S. Food and Drug Administration (FDA) for the treatment of pain following major surgery. DepoDur™ employs SkyePharma's proprietary DepoFoam™ technology and is supplied as a ready-to-use suspension. DepoDur™ was developed by SkyePharma Inc. (LSE: SKP; Nasdaq: SKYE). Endo licensed the exclusive rights to market DepoDur™ in the U.S. and Canada from SkyePharma in December 2002 when the product was in Phase III clinical trial development.
The May 18, 2004 FDA approval of DepoDur™ was based on clinical data showing significantly improved outcomes in 876 patients undergoing major surgical procedures such as hip replacement, lower abdominal surgery and elective Caesarean section. In clinical trials, patients given DepoDur™ demonstrated lower pain intensity scores and reduced need for rescue medication. In these trials, efficacy was assessed for at least 48 hours and safety was assessed for up to 30 days after DepoDur™ administration.
DepoDur™ is indicated for single-dose administration by the epidural route, at the lumbar level, for the treatment of pain following major surgery. DepoDur™ is administered prior to surgery or after clamping the umbilical cord during Caesarean section. DepoDur™ is not intended for intrathecal, intravenous, or intramuscular administration. Administration of DepoDur™ into the thoracic epidural space or higher has not been evaluated and therefore is not recommended.
As with all opioids, the primary side effect of DepoDur™ is respiratory depression, especially in elderly and debilitated patients and in those with compromised respiratory function; accordingly, patients must be monitored for a least 48 hours, and the facility must be equipped to resuscitate patients. No other medication should be administered in the epidural space for at least 48 hours after an administration of DepoDur™. DepoDur™ is contraindicated in patients with known hypersensitivity to morphine or the product's components, and in those patients with respiratory depression, acute or severe bronchial asthma, upper airway obstruction, those who have or are suspected of having paralytic ileus, head injury or increased intracranial pressure and those who are in circulatory shock. Any contraindications for an epidural injection preclude the administration of DepoDur™. Patients with depleted blood volume receiving DepoDur™ may experience severe hypotension. The most common adverse events reported in clinical studies (>10%) were: decreased oxygen saturation, hypotension, urinary retention, vomiting, constipation, nausea, pruritus, pyrexia, anemia, headache and dizziness. DepoDur™ is a Schedule II controlled substance and is subject to abuse and diversion.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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