FDA to Review Sublingual Pain Drug Used in Medically Supervised Settings
AcelRx announced the submission of a New Drug Application (NDA) for ARX-04 (sufentanil sublingual tablet) to the Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe acute pain in a medically supervised setting.
The NDA includes data from the ARX-04 clinical program consisting of four trials in which ARX-04 was evaluated as a treatment for moderate-to-severe acute pain in postoperative and emergency department patients. Study patients treated with ARX-04 showed improvements in pain intensity as soon as 15 to 30 minutes after dosing. The most common adverse events were nausea, headache, vomiting, and dizziness.
ARX-04 is an investigational drug candidate consisting of sufentanil 30mcg sublingual tablets, a synthetic opioid analgesic with a high therapeutic index. It is administered by a healthcare professional via a disposable, pre-filled, single-dose applicator. ARX-04 is being developed for use in supervised settings, including emergency medicine, outpatient or ambulatory surgery, non-surgical patients experiencing pain in the hospital, or post-operative patients, following short-stay surgery who do not require more long-term analgesia.
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