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NEW STUDY SHOWS IONSYS™
RATED COMPARABLY AS METHOD OF PAIN CONTROL TO INTRAVENOUS PATIENT-CONTROLLED MORPHINE AFTER TOTAL HIP REPLACEMENT
- Patients and nurses favorably rate patient-controlled, needle-free transdermal delivery
system on ease-of-use and care -
Raritan, NJ, December 19, 2006 -
A new study shows that IONSYS™(fentanyl iontophoretic transdermal system) CII*, the first needle-free,
patient-controlled analgesic delivery system, was rated comparably as a method of pain control to a
standard regimen of intravenous patient-controlled analgesia (IV PCA) with morphine, following total
hip replacement surgery.
The U.S. Food and Drug Administration approved IONSYS earlier this year as a treatment option for managing
acute postoperative pain in adults during hospitalization. It is a compact and self-contained system and
has built-in safety features. IONSYS securely adheres to the upper outer arm or chest, and provides
patients with on-demand doses of fentanyl. IONSYS is expected to be available in the second half of 2007.
According to the study results published in the November/December issue of Regional Anesthesia and Pain Medicine,
83 percent of patients treated with IONSYS and 82 percent treated with morphine IV PCA rated their method of
pain control in the first 24 hours as “excellent” or “good” using a patient global assessment (PGA) scale.
This rating constituted the study's primary efficacy outcome. Of patients treated with IONSYS, 51 percent
reported a PGA rating of “excellent” compared to 36 percent of those treated with morphine IV PCA.
Pain intensity, a secondary efficacy endpoint, was assessed on a scale of zero to 10.
Both groups of patients scored an average of three when pain intensity levels were assessed at
24 hours or upon study withdrawal. Based on each patient's self assessment, a zero score meant
the patient had “no pain” and a score of 10 meant the patient had the “worst
possible pain”.
Additionally, more patients who were treated with IONSYS gave favorable ratings
on assessments of overall ease-of-care, compared to patients in the morphine
IV PCA group: 43 percent versus 27 percent, respectively. The patient ease-of-care evaluation
addressed convenience of the method of pain control used, as well as satisfaction with the level
and method of pain control. Similarly, a higher percentage of nurses and physical therapists who
cared for patients treated with IONSYS gave favorable ratings on the overall ease-of-care assessments,
compared to nurses and physical therapists who cared for patients treated with morphine
IV PCA: 80 percent versus 55 percent among nurses, and 83 percent versus 55 percent among physical
therapists, respectively. The nurse ease-of-care evaluation looked at time involved, convenience,
and nurses' satisfaction with the PCA system. The physical therapist ease-of-care evaluation
assessed this group's satisfaction with the system used and the ease with which they completed
tasks and attained physical therapy session goals.
“Postoperative pain following hip replacement surgery is commonly managed with IV PCA,
and our study demonstrated that patients obtained comparable pain relief with IONSYS without
the needles, lines and bulky equipment that can compromise patient mobility and comfort,”
said study author Craig T. Hartrick, M.D., Director, Anesthesiology Research, William Beaumont Hospital,
Royal Oak, MI.
The most common adverse events experienced by patients in IONSYS and IV PCA groups,
respectively, were fever, 31 percent versus 30 percent; nausea, 30 percent versus 38 percent;
anemia, 14 percent versus 13 percent; vomiting, 11 percent versus 13 percent; hypotension,
7 percent versus 12 percent; and pruritus, 4 percent versus 8 percent. Thirty-eight or 10 percent
of patients in the IONSYS group experienced at least one application-site reaction. Most skin
reactions were considered mild or moderate in severity and were typically resolved without treatment.
About half as many patients in the IONSYS group experienced analgesic gaps that interrupted
pain control resulting from a system-related event, compared to patients in the morphine IV PCA group,
6 percent versus 12 percent, respectively. System-related events included device malfunction,
catheter infiltration, IV line inadvertently pulled out, and low or dead battery.
IV PCA systems, which are commonly used to administer medications for acute pain in the hospital setting, consist of a programmable machine, a pole, and connective tubing, which are attached to the patient through an IV line into his or her arm.
By contrast, IONSYS is the first and only needle-free, patient-controlled analgesic delivery system.
With IONSYS, when a dose of pain medication is needed, the patient double clicks a dosing button located
on the system. This activates a very low-intensity electrical field, generally not felt by the patient,
which delivers a pre-programmed dose of fentanyl through the skin. The medication is delivered over
a 10-minute period.
About the Study
The phase IIIb, multi-center, open-label study involved 799 patients who were randomized
to receive either IONSYS - which delivers 40 micrograms of fentanyl on demand, up to six doses per
hour - or 1 milligram of morphine every five minutes, up to 10 doses per hour, through IV PCA,
following total hip replacement surgery.
Overall drop out rates were similar in both groups, with more dropouts in the
IONSYS group due to inadequate analgesia and more dropouts in the morphine IV PCA group
due to adverse events. No patient receiving IONSYS experienced clinically relevant respiratory
depression; two cases occurred in the morphine IV PCA group.
Ortho-McNeil, Inc. funded and contributed to the management of this study.
All authors contributed to the design of the study and development of the manuscript
and had full editorial control over the content. Study authors Craig T. Hartrick, M.D.
and Michael H. Bourne, M.D. have served as consultants to Ortho-McNeil, Inc.
About IONSYS
In May 2006, the Food and Drug Administration approved the use of IONSYS in
the United States. In January 2006, the European Commission approved the use of IONSYS
in the 25 member states of the European Union. Ortho-McNeil, Inc. will market IONSYS
in the United States, and Janssen-Cilag companies will market the system in the European Union.
Final manufacturing process and scale up are being conducted by ALZA Corporation for expected
product distribution in the second half of 2007. ALZA, Ortho-McNeil, Inc. and Janssen-Cilag are
subsidiaries of Johnson & Johnson.
Please refer to the Full Prescribing Information for IONSYS, including the BOXED WARNING.
To obtain a copy, please contact the Ortho-McNeil Janssen Customer
Communications Center: 1-800-526-7736, or you may visit
www.ionsys.net/html/pion/prescribing.jsp.
Indications and Usage
INONSYS Indications and Usage
IONSYS is indicated for the short-term management of acute postoperative pain in adult patients requiring
opioid analgesia during hospitalization. Patients should be titrated to an acceptable level of analgesia before
initiating treatment with IONSYS. IONSYS is not intended for home use and is, therefore, inappropriate for use
in patients once they have been discharged from the hospital. It is not
recommended for patients under the age of 18 years (see WARNINGS and PRECAUTIONS in Prescribing Information).
Boxed Warning
IONSYS should only be used for the treatment of hospitalized patients. Treatment with IONSYS should be discontinued before patients are discharged from the hospital.
Treatment with fentanyl, the active component of IONSYS, may result in potentially life-threatening respiratory depression and death. To avoid potential overdosing, only the patient should activate IONSYS dosing.
Inappropriate use of IONSYS, leading to ingestion or contact with mucous membranes or unintended exposure to the fentanyl hydrogel, could lead to the absorption of a potentially fatal dose of fentanyl. Therefore, the hydrogels should not come into contact with fingers or mouth.
IONSYS contains fentanyl, a potent opioid agonist and Schedule II controlled substance with high potential for abuse similar to hydromorphone, methadone, morphine, and oxycodone. Fentanyl can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing IONSYS in situations where the Health Care Professional is concerned about an increased risk of misuse, abuse, or diversion. After the maximum dosage administration, a significant amount of fentanyl remains in the device.
IONSYS should always be kept out of reach of children.
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Important Safety Information
IONSYS is contraindicated in patients with known hypersensitivity to fentanyl, cetylpyridinium chloride (eg, Cepacol®) or any components of the IONSYS system.
IONSYS should be prescribed only by persons knowledgeable in the administration of potent opioids and in the management of patients receiving potent opioids for treatment of pain. Patients treated with IONSYS should be under the supervision of medical personnel with expertise in the detection and management of hypoventilation, including airway management and the use of opioid antagonists.
Since serum fentanyl concentrations decline gradually after system removal, patients who have experienced serious adverse events, including overdose, will require continued monitoring after removal of IONSYS.
To avoid potential overdosing, only the patient should activate IONSYS. Only patients who are able to follow the instructions to operate IONSYS should use the system. More than one IONSYS system should not be applied to a patient at the same time.
Prior to discharge from the hospital, medical personnel must remove the IONSYS system (see DOSAGE AND ADMINISTRATION, Disposal, in Prescribing Information). Contact with the hydrogels contained in IONSYS can be harmful to humans. Medical staff should handle the removed system carefully and only by the sides and top housing. Disposal should be in accordance with state and federal regulations for controlled substances.
Since the concomitant use of other CNS depressants may produce additive depressant effects, use of these agents requires individual adjustment of dosage of the concomitant medication and close observation of the patient.
IONSYS may impair the mental and/or physical ability required to perform potentially hazardous tasks.
IONSYS has not been studied in the treatment of breakthrough pain in patients on chronic opioid therapy and is not recommended for this purpose.
Patients on chronic opioid therapy or with a history of opioid abuse may require higher analgesic doses than are available from IONSYS and should be evaluated to ensure they are receiving adequate analgesia.
Fentanyl may cause potentially life-threatening respiratory depression. Patients with hypoventilation should be observed for degree of sedation and respiratory rate monitored until respiration is stabilized. IONSYS should be administered with caution to patients with pre-existing medical conditions predisposing them to hypoventilation.
IONSYS should not be used in patients susceptible to the intracranial effects of CO2 retention, such as increased intracranial pressure, impaired consciousness, or coma. Opioids may obscure the clinical course of patients with head injury. IONSYS should be used with caution in patients with brain tumors.
Fentanyl readily passes across the placenta to the fetus and is excreted in human milk; therefore IONSYS is not recommended for analgesia during labor and delivery or in nursing women.
The most common (greater than 10%) adverse events reported in 2114 patients treated with IONSYS 40 mcg/dose, including 3 placebo-controlled trials and 4 active comparator trials versus IV PCA morphine, regardless of relationship to study medication, were nausea, vomiting, application site reaction–erythema, fever, and headache.
About ALZA Corporation
ALZA Corporation is leading the next generation of drug delivery, with the world's broadest array of technology platforms, including oral, transdermal, implantable and liposomal technologies. ALZA's drug delivery technologies have been incorporated in more than 30 products, which are marketed in more than 80 countries worldwide.
About Ortho-McNeil, Inc.
Ortho-McNeil, Inc. is dedicated to providing innovative prescription medicines to advance patient care. Headquartered in Raritan, New Jersey, the company markets products to treat infectious diseases, gastrointestinal disorders, and pain. For more information, visit www.ortho-mcneil.com.
(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson 's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at
www.sec.gov or on request from Johnson & Johnson. Johnson & Johnson assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.)
*IONSYS contains fentanyl, a potent opioid agonist and a schedule II controlled substance.
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