AcelRx Pharmaceuticals (NSDQ:ACRX) said today that it plans to present data from a study evaluating its Dsuvia pain reliever in patients with moderate-to-severe acute pain resulting from trauma or injury.
The company’s Dsuvia 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.
AcelRx said it plans to present case studies of 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, the company said.
In the trial, the majority of patients reported no adverse events, according to AcelRx, but those that did reported nausea, somnolence and vomiting.
“Tissue damage from a severe burn is one of the most painful and disfiguring forms of trauma,” co-founder & chief medical officer Dr. Pamela Palmer said in prepared remarks. “While opioids are the standard-of-care to address the moderate-to-severe acute pain from burns, damaged tissue can make intravenous access difficult. With a product like Dsuvia, emergency physicians would have the option to administer a non-invasive opioid that potentially provides patients analgesia within 15-30 minutes.”
AcelRx said in December that it submitted a New Drug Application to the FDA for Dsuvia.
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.