AcelRx Pharmaceuticals (NSDQ:ACRX) said today that the FDA accepted the company’s New Drug Application for its Dsuvia pain relief therapy. The federal watchdog set a target decision date for October 12 this year.
The company’s Dsuvia candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator to patients with moderate-to-severe acute pain resulting from trauma or injury.
Dsuvia is investigational and not approved in any country.
“It is truly gratifying to see years of work developing a sublingual formulation of sufentanil and conducting multiple clinical trials finally come to this stage,” co-founder & chief medical officer Dr. Pamela Palmer said in prepared remarks. “We believe that Dsuvia will provide physicians and their patients a non-invasive treatment alternative in emergency medicine and short-stay or ambulatory surgeries for the treatment of moderate-to-severe acute pain.”
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.
Earlier this month, AcelRx touted data from case studies, including 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.