Johnson & Johnson subsidiary Alza has resubmitted its marketing application for Ionsys, a transdermal formulation of the opioid analgesic fentanyl hydrochloride, in the USA.
The company received an ‘approvable’ letter from the US Food and Drug Administration last year for the product, which is the first to use Alza’s E-TRANS iontophoretic drug delivery system. Iontopheresis uses a mild electrical current to allow drugs to cross the skin and into the bloodstream, and to date has only been used commercially in topical anaesthetic applications. Ionsys would represent the first systemic application of the system.
Ionsys is intended as an alternative to patient-controlled analgesia (PCA) systems that require intravenous lines. It has been developed to provide acute post-operative pain relief for patients in hospital.
If the NDA resubmission is accepted as satisfying the requirements for a complete response, the FDA could complete its review within six months, said Alza in a statement. If approved, Ionsys will be sold in the USA by J&J’s Ortho McNeil unit.
Ionsys has been recommended for approval in Europe, where it will be sold by Janssen-Cilag, another J&J subsidiary.