ALZA Corporation is modifying the US clinical development programme for Oros Hydromorphone (AP-77) for chronic pain. The company is considering different options for moving forward following recent discussions with the US Food and Drug Administration in which it became clear that an additional clinical trial would be required to meet the agency's standards for approval. The decision to modify the clinical development program was not related to any safety issues with the medication.
The clinical development programme in other regions of the world will continue, as previously planned. AP-77 is expected to launch in the European Union in 2006, informs a company release.
ALZA Corporation, a wholly owned subsidiary of Johnson & Johnson, is leading the next generation of drug delivery, with the world's broadest array of technology platforms, including oral, transdermal, implantable and liposomal technologies.