FDA to Review Zalviso (Sublingual Sufentanil) for Treatment of Acute Pain
Hospitalized patients self-dose with handheld system (December 2)
The FDA has accepted a new drug application (NDA) for Zalviso (AcelRx Pharmaceuticals), an investigational pre-programmed, noninvasive, handheld system that allows hospitalized patients with moderate-to-severe acute pain to self-dose with sublingual sufentanil microtablets to manage their pain.
The NDA, submitted Sept. 27, seeks approval for the marketing and sale of Zalviso for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The NDA submission is based primarily on data from a phase III registration program that included two double-blind randomized placebo-controlled clinical trials — one conducted in patients after major abdominal surgery, and the other in patients following major joint-replacement surgery.
In addition, a phase III open-label active-comparator trial was conducted in patients after either major abdominal or orthopedic surgery, comparing Zalviso with the current standard of care (intravenous patient-controlled analgesia [IV PCA] with morphine).
Zalviso achieved the primary efficacy endpoints for each of these studies.
Moderate-to-severe acute pain management in the hospital remains a challenge for health care providers, with up to 75% of patients reporting inadequate pain relief after surgery. Approximately 12 million surgical procedures per year result in moderate-to-severe pain in the U.S., with an additional 7.4 million hospital inpatients in the U.S. annually experiencing moderate-to-severe acute pain from other, non-postsurgical, medical conditions.
Source: AcelRx Pharmaceuticals; December 2, 2013.