AcelRx completes ARX-02 End-of-Phase 2 meeting with FDA for cancer breakthrough pain management system

AcelRx Pharmaceuticals, Inc. today announced that it has completed an End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) for ARX-02, a proprietary Sufentanil NanoTab™ Breakthrough Pain Management System for the treatment of cancer breakthrough pain in opioid-tolerant patients. FDA reviewed a package based on the previously announced positive Phase 2 clinical study results to date for ARX-02 and provided AcelRx with guidance on the Phase 3 program design and NDA requirements.

Richard King, AcelRx CEO stated, "Given this guidance, we have clarity on the development path for ARX-02 in cancer breakthrough pain. In addition, FDA provided clarity on the development requirements to register ARX-02 for the broader indication of chronic breakthrough pain in opioid-tolerant patients, where we believe that ARX-02 can have an impact on the lives of a broader array of opioid-tolerant patients."