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news.Alza Corporation, a wholly owned subsidiary of Johnson & Johnson, has resubmitted its new drug application for Ionsys, an investigational iontophoretic transdermal system for acute postoperative pain.
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Alza originally submitted the application for licensure of Ionsys to the FDA in September 2003, but received an approvable letter from the FDA in mid-2004 informing the company that more information would be required before the drug could be approved. The latest new drug application (NDA) constitutes the company’s response to the 2004 approvable letter.
Ionsys is the first product in development to incorporate the proprietary e-trans iontophoretic transdermal drug delivery system developed by Alza. The system delivers drug systemically by using low-level electrical energy to actively transport drugs through intact skin. The active ingredient of Ionsys is an opioid analgesic, fentanyl hydrochloride.
If the NDA resubmission is accepted as satisfying the requirements for a complete response, the FDA could complete its review within six months, under the prescription drug user fee act (PDUFA). Pending FDA approval, Ionsys will be marketed in the US by Ortho-McNeil, another subsidiary of Johnson & Johnson.
Ionsys is also awaiting approval in the European Union. This October, the European Committee for Medicinal Products for Human Use adopted a positive opinion recommending marketing authorization for the product in the 25 member states of the European Union.