AcelRx Pharmaceuticals, Inc. today announced that it has successfully completed an End-of-Phase 2 meeting with the FDA for ARX-01, a drug/device combination product based on the company's proprietary NanoTab(TM) dosage form, which enables delivery of sufentanil by the non-invasive oral transmucosal (sublingual) route. ARX-01 offers a non-invasive alternative to intravenous patient-controlled analgesia (IV PCA) for the management of acute post-operative pain in the hospital setting. The FDA reviewed a package based on positive Phase 2 clinical study results from three Phase 2 trials which demonstrated the functionality of the ARX-01 device and the safety and efficacy of Sufentanil NanoTabs(TM) for the treatment of moderate-to-severe acute pain following knee replacement surgery and abdominal surgery. The FDA provided AcelRx with guidance on Phase 3 study design, regulatory strategy, and NDA requirements. Commenting on the meeting, Pamela Palmer, MD, PhD, AcelRx Chief Medical Officer stated, "We are glad to have FDA input on the NDA requirements for this novel approach to post-operative pain management. Given this guidance, our path to market is now clear. We believe that ARX-01 will make a meaningful impact on patient lives by addressing the current shortcomings of IV PCA by reducing invasiveness, reducing unintended dosing errors, increasing patient mobility and simplifying the demands on health care providers."
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