An on-demand painkiller product that uses an electric current to deliver an opioid analgesic across the skin and could provide an effective alternative to injections has moved a step closer to approval in Europe.
Johnson & Johnson’s Ionsys (fentanyl hydrochloride) Iontophoretic Transdermal Syndrome has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) to provide acute post-operative pain relief for patients in hospital.
At the moment, patient-controlled analgesia is the current standard for post-operative pain management and usually consists of a programmable machine, a pole and connective tubing, which are attached to the patient via an intravenous line into their arm. Other methods of post-operative pain management, such as intramuscular and intravenous injections, are less cumbersome, but do not offer patients control.
According to the CHMP, the benefits with Ionsys are its ability to provide effective analgesia over 24 hours via a non-invasive, patient-controlled delivery system. It takes the form of a self-contained patch that is applied to the skin on the upper arm or chest. Patients control their analgesia by pushing a button, and the system immediately delivers a small dose of short-acting analgesic.
Ionsys uses an electric current to help deliver drugs across the skin – a process known as iontophoresis that makes it possible to expand the range of drugs that can be delivered by the transdermal route. Ionsys is one of just a handful of iontophoretic products to reach this stage of development, and is also the first product to incorporate the E-TRANS drug delivery system developed by J&J subsidiary ALZA Corp.
Once approved, Ionsys will be sold by J&J subsidiary, Janssen-Cilag, across the EU. The product is also under review by the US Food and Drug Administration and, if approved, will be sold there by J&J’s Ortho-McNeil unit.
The first product to reach the market using an iontophoretic delivery system was Iomed’s Iontocaine (lidocaine), an anaesthetic product used to provide localised pain relief for minor surgical procedures, which debuted in the 1990s. Last year. Vyteris launched its LidoSite (lidocaine and epinephrine) product for similar applications. However, Ionsys is thought to be the first systemic application of the technology.
