AcelRx Pharmaceuticals (NSDQ:ACRX) said today that it submitted a new drug application to the FDA for its ARX-04 sublingual sufentanil tablet. The non-invasive compound has been studied as a treatment for patients experiencing moderate or severe acute pain and is administered in a medically supervised setting using a disposable, pre-filled, single-dose applicator.
The Redwood City, Calif.-based company’s NDA was supported by the sufentanil tablet’s clinical program, which included 4 clinical trials evaluating the sublingual painkiller as a treatment for acute pain in postoperative and emergency department patients. The data showed that patients treated with the sufentanil therapy demonstrated alleviation from pain as early as 15 minutes after they were dosed. Adverse events associated with treatment were similar to that of opioid therapy – nausea, headache, vomiting and dizziness.
Get the full story at our sister site, Drug Delivery Business News.
The post AcelRx seeks FDA nod for non-invasive sufentanil painkiller appeared first on MassDevice.