Sufentanil citrate is under clinical development by Talphera and currently in Phase III for Post-Operative Pain. According to GlobalData, Phase III drugs for Post-Operative Pain have a 37% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Sufentanil citrate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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).

Talphera overview

Talphera, formerly 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. Talphera developed a proprietary, non-invasive, sublingual formulation technology to deliver its highly lipophilic drugs. Talphera is headquartered in Hayward, California, the US.

For a complete picture of Sufentanil citrate’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 February 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.