Sufentanil citrate is under clinical development by AcelRx Pharmaceuticals and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Sufentanil citrate’s likelihood of approval (LoA) and phase transition for Post-Operative Pain took place on 16 Aug 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Sufentanil citrate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Sufentanil citrate overview

Sufentanil citrate (Zalviso, Arx-F01) is anilide derivative acts as an opioid analgesic agent. It is formulated as a tablet for the sublingual route of administration. It is indicated for the management of acute moderate-to-severe post-operative pain in hallux valgus (Bunion) surgery. Arx-01 is a drug-device combination product utilizing the opioid agonist sufentanil formulated in a proprietary sublingual tablet formulation and delivered through a pre-programmed, non-invasive proprietary delivery device. The drug candidate is based on nanotab technology. Nanotab technology is a non-invasive, sublingual dosage form that efficiently delivers highly lipophilic drugs with consistent pharmacokinetics. Nanotab dosage forms are designed to minimize the natural saliva response, reducing the amount of swallowed drug that results from the oral transmucosal administration. Sufentanil citrate (Zalviso) is under development for the treatment of acute moderate-to-severe post-operative pain (in the US).

AcelRx Pharmaceuticals overview

AcelRx Pharmaceuticals (AcelRx), is a specialty pharmaceutical company that develops and commercializes drugs for the treatment of pain. The company’s lead product candidate, Dsuvia (known as Dzuveo in Europe), is a single sufentanil sublingual tablet for treating of moderate-to-severe acute pain. Its pipeline also includes Zalviso (for US market), a drug and device combination product for the management of moderate to severe acute pain in adults. AcelRx developed a proprietary, non-invasive, sublingual formulation technology to deliver its highly lipophilic drugs. The company commercializes its EC-approved Zalviso under a license agreement with Grunenthal in Europe and Australia. AcelRx is headquartered in Hayward, California, the US.

Quick View Sufentanil citrate LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Sufentanil citrate
Administration Pathway
  • Sublingual
Therapeutic Areas
  • Central Nervous System
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.