Dsuvia Approved to Manage Severe Acute Pain
November 2, 2018 – The U.S. FDA has approved Dsuvia™ (sufentanil sublingual tablet 30mcg), manufactured by AcelRx and developed in coordination with the Department of Defense, to manage acute pain that is sufficiently severe to require an opioid analgesic. Dsuvia is indicated use with adult patients in certified, medically supervised healthcare settings.
Sublingual tablets melt under the tongue, and the medication is absorbed directly into the body. This mechanism allows Dsuvia to provide pain management for patients who are unable to swallow medication or who have poor vein access for intravenous administration of pain management therapies. Because of its mechanism of delivery, the drug also has applications in combat situations. This made its development a priority for the Department of Defense, as the product has the ability to fulfill an unmet medical need for soldiers wounded in the line of duty.
Access to Dsuvia will be tightly restricted through a Risk Evaluation and Mitigation Strategy (REMS) for use in certified, medically supervised health care settings such as hospitals, surgical centers, and emergency departments. The drug must be administered by a health care professional. Recommended dosing is one tablet given as needed, with a space of at least one hour between doses. No more than 12 doses should be given in a 24-hour period.
Dsuvia carries a number of black box warnings that describe the risk of accidental exposure; serious, life-threatening, or fatal respiratory depression; fatal overdose when used with CYP3A4 inhibitors or with discontinuation of CYP3A4 inducers; opioid addiction, misuse, and abuse; and increased risk of respiratory depression when used with benzodiazepines.
AcelRx plans to launch Dsuvia during the first quarter of 2019. Pricing information has yet not been announced.