AcelRX Submits NDA to FDA for Investigational Pain Product

AcelRX has submitted a New Drug Application (NDA) to the FDA for ARX-04 (sufentanil tablets).

AcelRX has submitted a New Drug Application (NDA) to the FDA for ARX-04 (sufentanil tablets). The 30-mcg tablets are indicated to treat patients who have moderate-to-severe acute pain in a medically supervised setting.

Sufentanil is a synthetic opioid analgesic with a high therapeutic index. It has no known active metabolites. The product is meant to be delivered using a disposable, pre-filled, single-dose applicator.

Some of the adverse effects of sufentanil are respiratory depression and skeletal muscle rigidity. Gastrointestinal effects, such as nausea and vomiting, have also been reported. The most common adverse events are headache, vomiting, and nausea.

“We are in the process of completing our commercialization plans so that we will be ready for an initial pilot launch in 2017, should ARX-04 be approved by the FDA,” said Howie Rosen, chief executive officer of AcelRx, in a press release. “We also are using the NDA to prepare a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a target submission date in the first half of 2017.”

The NDA includes information from the ARX-04 clinical program, which has data from 4 clinical trials in which the product was assessed for moderate-to-severe pain. Specifically, it was examined while being used in postoperative and emergency department patients. Individuals appeared to show improvements in pain intensity as early as 15-to-30 minutes after the start of dosing.