Study of Zalviso in moderate to severe pain published in Anesthesiology journal.- AcelRx Pharma.

AcelRx Pharmaceuticals announced the publication of an analysis of the pharmacokinetic characteristics of sublingually administered tablets containing Zalviso (sufentanil sublingual tablet system) containing 15 or 30 mcg of sufentanil, in a special "Frontiers in Opioid Pharmacotherapy" edition of the peer-reviewed journal, Anesthesiology. The manuscript reports on the results of pharmacokinetic analyses using blood sampled from both healthy subjects and surgical patients in AcelRx clinical trials in order to determine the effects of weight, age, sex, and organ impairment on apparent clearance of sufentanil from plasma following tablet administration.

The study concluded that sublingual sufentanil tablets provide the opportunity to non-invasively and rapidly treat moderate-to-severe pain in a monitored setting. Following dosing of the 30 mcg sufentanil sublingual tablet, therapeutic sufentanil plasma concentrations were reached within 30 minutes and remained above this level for approximately 3 hours, consistent with the onset and duration of analgesia observed in the clinical trials. The results also indicated that drug clearance, which increased slightly with weight and decreased slightly with age, was not affected by sex of the patient or by hepatic or renal impairment.

See: "Pharmacokinetic Properties of a Sufentanil Sublingual Tablet Intended to Treat Acute Pain." Fisher D, Chang P, Wada R, Dahan A, Palmer P. Anesthesiology. 2018 May.

Comment: The Zalviso system, in-licensed from AcelRx Pharmaceuticals, is for use in hospitals and offers several safety features for patients. It utilizes the opioid agonist sufentanil formulated in a proprietary sublingual tablet and delivered through an easy to use pre-programmed, non-invasive administration device.