FDA panel recommends pain drugDecember 13, 2018
The Anesthetic and Analgesic Drug Products Advisory Committee of the USFDA recommended the approval of Sufentanil citrate (Dsuvia) for the management of moderate-to-severe acute pain, announced AcelRx Pharmaceuticals.
Sufentanil is a potent opioid analgesic that has been previously used for intravenous administration in adults and paediatricpatients.
Now, sufentanil 30 mcg tablet has been recommended for sublingual use and is to be taken on an “as needed” basis, with a minimum of one hour between doses and a maximum cumulative daily dose of 360 mcg or 12 tablets per 24-hour period.
The potency of sufentanil is 500 to 1000-fold higher than oral morphine, and with highly selective binding to µ–opioid receptors.
AcelRx presented data showing efficacy and safety of sufentanil from two randomized, placebo-controlled studies with a total of 261 patients and two open-label, single-arm studies with a total of 216 patients.