The FDA has changed how often AcelRx Pharmaceuticals is required to audit healthcare settings that administer Dsuvia, which is a synthetic opioid.
The FDA has recently modified the Dsuvia Risk Evaluation and Mitigation Strategies (REMS), eliminating the six-month healthcare setting audit requirement and reducing annual healthcare setting audits. Previously the FDA required the manufacturer, AcelRx Pharmaceuticals, to audit all healthcare settings within six months of an initial order, and to then continue to audit all such sites annually thereafter.
The FDA approved Dsuvia (sufentanil), a synthetic opioid, in November 2018 for the management of acute pain severe enough to require an opioid analgesic. It is a sublingual tablet that was designed to provide rapid pain relief and to eliminate dosing errors associated with intravenous administration.
Dsuvia was approved with a REMS program to ensure proper use and administration. The REMS required distribution through certified healthcare settings and required AcelRx to audit these facilities.
Pamela Palmer, M.D., Ph.D.
“We continue to work closely with the FDA on the Dsuvia REMS program and have established a track record of compliance and safety, including lack of accidental exposure,” Pamela Palmer, M.D., Ph.D., co-founder and chief medical officer of AcelRx, said in a press release. “We believe that it is this history of stewardship and responsibility, which is included in our latest three-year assessment REMS report as submitted to the FDA, that has resulted in the lowering of both the number and frequency of required site audits.”
In February 2021, the FDA had issued a warning letter to AcelRx about false and misleading advertising. The company’s “Tongue and Done” campaign, the agency said, minimized the risk of serious adverse events and undermined the conditions for safe use. The company in a 2021 earnings release said that it been notified by the FDA that AcelRx had met all requirements of the warning letter.
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More