European Authorities recommend IONSYS approval

By Wai Lang Chu

- Last updated on GMT

Related tags Opioid

European Authorities recommended the first needle-free system for
acute postoperative pain for approval this week, which allows
patient-controlled delivery of fentanyl in post-operative pain

Intravenous patient-controlled analgesia systems (IV PCA), are the current standard for post-operative pain management. They are used to administer medications for acute pain in the hospital environment.

Normally, they consist of a programmable machine, a pole and connective tubing, which are attached to the patient via an intravenous line into their arm.

The system is lightweight and approximately the size of a credit card that adheres to a patient's upper arm or chest.

IONSYS, produced by the ALZA Corporation, a member of the Johnson & Johnson family of companies, aims to become a viable alternative to daily injections for patients, which when applied to the skin on the upper arm or chest, the low-intensity electrical current delivers the medication directly through the skin, and into the systemic circulation.

Patients control their analgesia by pushing a button, and the system immediately delivers a small dose of the short-acting analgesic fentanyl, a prescription pain medication.

IONSYS claims to offer a unique combination of drug delivery attributes, including a rapid onset of action comparable to intravenous administration, a sustained effect, and the ability to provide personalised, incremental dosing that allows for adjustment to suit a patient's specific needs.

The mode of action, which IONSYS incorporates, uses the E-TRANS drug delivery system developed by ALZA Corporation, a Johnson & Johnson company.

E-TRANS can deliver drug systemically by using low-level electrical energy to actively transport drugs through intact skin.

E-TRANS transdermal technology has been used in Alza's Duragesic patches, launched in 1991. The DURAGESIC (fentanyl transdermal system)CII patch is medication for moderate-to-severe chronic pain, providing relief from persistent pain.

Once approved, Janssen-Cilag will market the system in all countries of the European community. IONSYS (Fentanyl HCI ITS) is currently under review by the United States Food and Drug Administration and, if approved, Ortho-McNeil will market Ionsys in the United States.

Current methods of post-operative pain management, such as intramuscular and intravenous injections, are less cumbersome, but do not offer patients control.

IONSYS' active substance - Fentanyl is an opioid agonist and a Schedule II controlled substance with high potential for abuse similar to hydromorphone, methadone, morphine and oxycodone.

The most common side effects associated with IONSYS in clinical trials were nausea, vomiting and headache. These were mostly of mild-to-moderate in severity.

IONSYS provided post-operative pain relief to most patients undergoing gynaecologic surgery without the needles, lines and pumps needed for IV PCA.

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