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IONSYS® (fentanyl iontophoretic transdermal system) CII
Study Design: Pivotal Phase 3 Placebo-controlled Studies

  • Prospective, randomized, multicenter, double-blind, placebo-controlled, parallel group design1-3
  • Patients with acute postoperative pain expected to last at least 24 hours1-3
  • Prior to randomization, patients were titrated to comfort postoperatively1-3
  • Rescue analgesia was allowed during the first 3 hours following randomization1-3
  • After 3 hours, patients requiring additional analgesia were discontinued due to inadequate analgesia1-3

Clinical studies publication list for IONSYS(R) (fentanyl iontophoretic transdermal system) CII

*Single center only.
†PGA consisted of a categorical evaluation (excellent, good, fair, or poor) of the method of pain control.

  1. IONSYS® [prescribing information], Parsippany, NJ: The Medicines Company; 2016.
  2. Chelly JE, Grass J, Houseman TW, Minkowitz H, Pue A. The safety and efficacy of a fentanyl patient-controlled transdermal system for acute postoperative analgesia: a multicenter, placebo-controlled trial. Anesth Analg. 2004;98:427-433.
  3. Viscusi E, Reynolds L, Tait S, Melson T, Atkinson L. An iontophoretic fentanyl patient-activated analgesic delivery system for postoperative pain: a double-blind, placebo-controlled trial. Anesth Analg. 2006;102:188-194.

IONSYS® (fentanyl iontophoretic transdermal system) CII
Has Been Studied in a Variety of Surgical Procedures

C-95-016 (Data on file)1
Surgical procedure
IONSYS® (n=77)
No. (%)
Placebo (n=25)
No. (%)
Lower abdominal
58 (75.3)
18 (72.0)
Orthopedic bone
16 (20.8)
7 (28.0)
Upper abdominal
3 (3.9)
0 (0.0)
Other
0 (0.0)
1 (4.0)
C-2000-008 (Chelly 2004)2
Surgical procedure
IONSYS® (n=154)
No. (%)
Placebo (n=51)
No. (%)
Lower abdominal
82 (53.2)
25 (49.0)
Orthopedic bone
54 (35.1)
20 (39.2)
Thoracic/chest
2 (1.3)
0 (0.0)
Upper abdominal
12 (7.8)
6 (11.8)
Other
4 (2.6)
0 (0.0)
C-2000-011 (Viscusi 2006)3
Surgical procedure
IONSYS® (n=244)
No. (%)
Placebo (n=240)
No. (%)
Lower abdominal
118 (48.4)
115 (47.9)
Orthopedic bone
114 (46.7)
109 (45.4)
Thoracic/chest
6 (2.5)
7 (2.9)
Upper abdominal
2 (0.8)
5 (2.1)
Other
4 (1.6)
4 (1.7)
  1. Data on file. The Medicines Company.
  2. Chelly JE, Grass J, Houseman TW, Minkowitz H, Pue A. The safety and efficacy of a fentanyl patient-controlled transdermal system for acute postoperative analgesia: a multicenter, placebo-controlled trial. Anesth Analg. 2004;98:427-433.
  3. Viscusi E, Reynolds L, Tait S, Melson T, Atkinson L. An iontophoretic fentanyl patient-activated analgesic delivery system for postoperative pain: a double-blind, placebo-controlled trial. Anesth Analg. 2006;102:188-194.

Primary Endpoint: Pivotal Phase 3 Placebo-controlled Studies

  • Percentage of patients who discontinued due to inadequate analgesia1-3
  • Evaluable for efficacy patients were those that remained in the trial from 3 to 24 hours

Primary endpoint data for Phase 3 placebo-controlled studies for IONSYS(R) (fentanyl iontophoretic transdermal system) CII

  1. IONSYS® [prescribing information], Parsippany, NJ: The Medicines Company; 2016.
  2. Chelly JE, Grass J, Houseman TW, Minkowitz H, Pue A. The safety and efficacy of a fentanyl patient-controlled transdermal system for acute postoperative analgesia: a multicenter, placebo-controlled trial. Anesth Analg. 2004;98:427-433.
  3. Viscusi E, Reynolds L, Tait S, Melson T, Atkinson L. An iontophoretic fentanyl patient-activated analgesic delivery system for postoperative pain: a double-blind, placebo-controlled trial. Anesth Analg. 2006;102:188-194.

Adverse Reactions With Incidence ≥2%: Pivotal Phase 3
Placebo-controlled Studies (N=791; 24-hour Duration)1

Adverse reactions
IONSYS®
(N=475)
Placebo
(N=316)
Body as a whole
Headache
9%
7%
Cardiovascular system
Hypotension
2%
<1%
Digestive system
Nausea
39%
22%
Vomiting
12%
6%
Hemic ans Lymphatic system
Anemia
3%
<1%
Nervous system
Dizziness
3%
1%
Skin system
Application site reaction - Erythema
14%
2%
Pruritus
6%
<1%
Urogenital system
Urinary retention
3%
<1%
  1. IONSYS® [prescribing information], Parsippany, NJ: The Medicines Company; 2016.

Explore a list of publications related to IONSYS® in the Publications section of this website.

Important Safety Information

WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION; IONSYS® REMS; ADDICTION, ABUSE, AND MISUSE; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of IONSYS®. Monitor for respiratory depression, especially during initiation of IONSYS®. Only the patient should activate IONSYS® dosing.

IONSYS Risk Evaluation and Mitigation Strategy (REMS) Program

  • IONSYS® is for use only in patients in the hospital. Discontinue treatment with IONSYS® before patients leave the hospital.
  • Because of the risk of respiratory depression from accidental exposure, IONSYS® is available through a restricted program called the IONSYS® REMS Program. Healthcare facilities that dispense IONSYS® must be certified in this program and comply with the REMS requirements.

Addiction, Abuse, and Misuse

IONSYS® exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions.

Cytochrome P450 3A4 Interaction

The concomitant use of IONSYS® with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving IONSYS® and any CYP3A4 inhibitor or inducer.

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

  • Reserve concomitant prescribing of IONSYS® and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

Contraindications

Warnings and Precautions

Adverse Reactions

Most common adverse reactions (frequency ≥2%) were headache, hypotension, nausea, vomiting, anemia, dizziness, application site reaction-erythema, pruritus, and urinary retention.

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