Sufentanil

Unassigned

New Medicines

Dzuveo (EU); Dsuvia (US) · Acute pain - single-dose sublingual formulation (30 micrograms)

Information

Dzuveo (EU); Dsuvia (US)
New formulation
AcelRx Pharmaceuticals
AcelRx Pharmaceuticals

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Launched
Apr 19 · In its 2018 annual report, AcelRx do not describe commercialisation plans for Dzuveo in the EU (unlike Zalviso, a similar sulfentanil product, which is marketed by Grünenthal in the EU). Presume they are still seeking commercial partners [12].
Feb 19 · Sufentanil sublingual 30mcg tablet launched in the US with the brand name DSUVIA [11].
Jan 19 · In its 2018 annual filing, AceRx reports that its strategy with respect to Dzuveo in territories outside of the United States is seek commercial partnerships [10].
Nov 18 · AcelRx Pharmaceuticals plans to launch sufentanil sublingual in the US in Q1 19 [9].
Nov 18 · Approved in the US, despite a letter to the FDA from the Anesthetic and Analgesic Drug Products Advisory Committee chair pleading for rejection, expressing concerns about its potency and potential for diversion, abuse and death. However the formulation will not be available in retail pharmacies and will require administration by a healthcare professional in a medically supervised setting, such as hospitals and emergency rooms, under a restrictive risk-management plan mandated by the FDA. AcelRx plans to price Dsuvia at $50 to $60 [8].
Jun 18 · Approved in EU [8].
Apr 18 · Recommended for approval by CHMP: the full indication is "for the management of acute moderate to severe pain in adult patients" [7].
Oct 17 · AcelRx Pharmaceuticals announces intention to resubmit NDA to US FDA by end of 2017 [6].
Oct 17 · The FDA has issued a Complete Response Letter rejecting the New Drug Application and requesting further data. It requires additional safety data for the maximum dose of the drug from at least 50 trial participants, and it is also recommending changes to the directions for use to address use-related errors, to be validated through a human factors study. AcelRx considers that the requests are manageable and intends to meet with the FDA to discuss the issues and plan resubmission [5].
Mar 17 · MAA submitted to EMA for use in patients with moderate to severe acute pain in a medically supervised setting [4].
Dec 13 · AcelRx meets with the FDA to identify a PIII programme pathway [2].

Category

a sublingual formulation of the opioid analgesic sufentanil for the treatment of acute pain (ARX 04; single-dose formulation).
Acute pain - single-dose sublingual formulation (30 micrograms)
Sublingual

Trial or other data

Feb 16 · AcelRx announces interim PIII results. 40 patients dosed so far with ARX-04 demonstrated a quick, sharp drop in pain scores after turning up at the ER [3].
Sep 15 · AcelRx announces positive data from its late-stage study. Sublingual sufentanil tablet ARX-04 met the primary and secondary endpoints set out for patients with moderate-to-severe acute pain following ambulatory abdominal surgery [1].
Mar 15 · AcelRx reports initiation of a PIII trial which will evaluate safety and efficacy of ARX-04 for treatment of moderate-to-severe acute pain, in an emergency room setting (SAP302; NCT02447848). The open-label trial is designed to enrol approximately 40 patients in the US [2].
Apr 13 · Top-line results from a PII dose-finding study of sublingual sufentanil in patients with acute pain following bunionectomy surgery were reported by AcelRx (NCT01710345). Initiated in November 2012, the trial randomised 101 patients to receive sufentanil 20µg, sufentanil 30µg, or placebo [2].

Evidence based evaluations