Needle-free analgesia device close to approval

>Alza​ has resubmitted a New Drug Application (NDA) to the FDA for Ionsys - the first product to incorporate the company's new E-TRANS iontophoretic transdermal drug delivery system.

If the resubmission is accepted as satisfying the requirements for a complete response, the FDA could complete its review within six months.

This product will provide a welcome alternative to patient-controlled analgesia (PCA) systems that require intravenous lines and has been developed to provide acute post-operative pain relief for patients in hospital.

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

Ionsys is a transdermal formulation of the opioid analgesic fentanyl hydrochloride, that is delivered to the patient via Alza's patient-activated transdermal system (PATS).

The system delivers the drug systemically by using low-level electrical energy to actively transport the drug through the patient's intact skin and into the bloodstream.

Ionsys will be the first systemic application of the novel drug delivery system. Previously it has been used commercially in topical anaesthetic applications.

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

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 NDA resubmission is in response to an approvable letter from the FDA received by Alza, a wholly owned subsidiary of Johnson & Johnson, in 2004. The company originally submitted the application for licensure of Ionsys to the FDA in September 2003.

If approved, Ionsys will be sold in the USA by Ortho-McNeil, a subsidiary of Johnson & Johnson.

In October, Ionsys was also recommended for approval in Europe by the European Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency.

If approved, it will be sold throughout Europe by Janssen-Cilag, another Johnson & Johnson subsidiary.