The company’s lead drug candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator. Dsuvia is investigational and not approved in any country.
The 4 late-phase studies enrolled 480 patients total. In 2 randomized studies, enrolled patients underwent bunionectomy and abdominal surgeries and were treated for post-operative pain. The other 2 trials evaluated Dsuvia in the emergency department and in older, post-operative patients.
Based on the data, researchers concluded that Dsuvia could be used as a non-invasive analgesic modality in medically supervised settings for the short-treatment of acute pain. In the emergency department study, patients who were treated with Dsuvia had a 3-point reduction in pain intensity within 60 minutes of administration, the company said, and experienced clinically meaningful relief within 30 minutes.
Across all 4 studies, adverse events were mild-to-moderate in severity, AcelRx said. The most commonly reported events were nausea, headache and vomiting.
In February, Redwood City, Calif.-based AcelRx presented data involving its pain killer and 2 burn victims – a 26-year old female with a 2nd degree burn on the right thigh, as well as a 49-year old male with 2nd and 3rd degree burns covering 13% of his body.
Along a 10 point scale, both patients reported a baseline pain intensity of 8. After 1 dose of Dsuvia, both patients reported a 2 point decrease in pain intensity within 15 minutes.