Dsuvia (sufentanil sublingual) / Talphera, Alora Pharma, Xoma - LARVOL DELTA

Low-dose sufentanil does not affect tolerance to LBNP-induced central hypovolemia or blood pressure responses during the cold pressor test. (PubMed, Am J Physiol Regul Integr Comp Physiol) - "The purpose of this study was to test two unique hypotheses: a) sublingual sufentanil (Dsuvia) impairs tolerance to progressive central hypovolemia, and b) sublingual sufentanil attenuates pain sensation and the accompanying cardiovascular responses to a noxious stimulus...These data demonstrate that sublingual sufentanil does not impair tolerance to progressive central hypovolemia. Additionally, sublingual sufentanil attenuates perceived pain, but not the accompanying mean blood pressure responses to the CPT."

Journal • Cardiovascular • Hematological Disorders • Pain

DEEP: DSUVIA Early Evaluation of Pain Trial (clinicaltrials.gov) - P3 | N=150 | Completed | Sponsor: Frank Guyette | Recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Jan 2024

Trial completion • Trial completion date • Pain

XOMA Expands its Commercial Royalty and Milestone Portfolio with DSUVIA Acquisition (GlobeNewswire) - "XOMA Corporation...announced today it has acquired an economic interest in DSUVIA^® (sufentanil sublingual tablet) from Talphera, Inc., for $8 million...In April 2023, Talphera divested DSUVIA^® to Alora Pharmaceuticals for an upfront payment, a 15 percent royalty on commercial net sales, a 75 percent royalty on net sales to the U.S. Department of Defense (DoD), and up to $116.5 million in milestone payments....Under the terms of the agreement, XOMA will receive 100 percent of all royalties and milestones related to DSUVIA^® sales until the Company receives $20 million. Thereafter, XOMA fully retains the 15 percent royalty associated with DSUVIA^® commercial sales, and the 75 percent royalties generated from DoD purchases will be shared equally between XOMA and Talphera, as will the remaining $116.5 million in potential milestone payments due from Alora Pharmaceuticals."

Licensing / partnership • CNS Disorders • Pain

DEEP: DSUVIA Early Evaluation of Pain Trial (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Frank Guyette | Suspended ➔ Recruiting

Enrollment open • Pain

Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment (clinicaltrials.gov) - P4 | N=3 | Terminated | Sponsor: Montefiore Medical Center | N=30 ➔ 3 | Trial completion date: May 2023 ➔ Nov 2022 | Recruiting ➔ Terminated | Trial primary completion date: May 2023 ➔ Nov 2022; Terminated early due to funding, lack of participants

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Pain

DEEP: DSUVIA Early Evaluation of Pain Trial (clinicaltrials.gov) - P3 | N=150 | Suspended | Sponsor: Frank Guyette | Recruiting ➔ Suspended

Trial suspension • Pain

AcelRx Pharmaceuticals Announces Closing of Divestment of DSUVIA to Alora Pharmaceuticals (PRNewswire) - "AcelRx Pharmaceuticals, Inc...announced the closing of its divestment of DSUVIA^® to Alora Pharmaceuticals (Alora). In connection with the closing of the transaction, AcelRx received a total of approximately $2.7 million from Aguettant and Alora. On March 14, Alora agreed to acquire all assets related to DSUVIA, including inventories, equipment and intellectual property in exchange for consideration at closing of $1.1 million, a 15% royalty on commercial sales of DSUVIA, 75% royalty on sales of DSUVIA to the Department of Defense and up to $116.5 million in sales-based milestones. In connection with the closing, AcelRx also decided to fully repay its senior loan with Oxford Finance, leaving the company debt-free after the closing of the transaction."

Commercial • CNS Disorders • Pain

"$ACRX Divests FDA Approved Pain-Management Drug Dsuvia to Alora Pharma" (@BioStocks)

FDA event • Pain

"$ACRX AcelRx Pharmaceuticals Announces Divestment of DSUVIA® to Alora Pharmaceuticals https://t.co/PuYnjjSLxb" (@stock_titan)

DEEP: DSUVIA Early Evaluation of Pain Trial (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Frank Guyette | Not yet recruiting ➔ Recruiting

Enrollment open • Pain

The Impact Of Sublingual Sufentanil On Postoperative Pain Control In Patients Undergoing Spine Surgery (ASA 2022) - P4 | "In 2018, the FDA approved Sublingual Sufentanil Tablet (SST), known as Dsuvia®...Control Arm 1 received intraoperative remifentanil and Control Arm 2 intraoperative sufentanil infusion and both received hydromorphone for postoperative pain... SST appears to be an effective alternative analgesic therapy in spine surgery patients who experience moderate to severe postoperative pain, resulting in improved pain scores in the postoperative recovery period. Further analysis will examine the impact on postoperative consumption and hospital length of stay."

Clinical • Anesthesia • Orthopedics • Pain

Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Montefiore Medical Center | Trial completion date: Mar 2022 ➔ May 2023 | Trial primary completion date: Mar 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Pain

DSUVIA in Patients With SCD VOC Present in the ED (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Jason Wilson

New trial • Genetic Disorders • Hematological Disorders • Sickle Cell Disease

Improving Pain Management and Decreasing LOS After Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA) (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: More Foundation

New P4 trial • Orthopedics • Pain

DEEP: DSUVIA Early Evaluation of Pain Trial (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Frank Guyette

New P3 trial • Pain

AcelRx Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results (PRNewswire) - "AcelRx Pharmaceuticals, Inc...today reported its fourth quarter and full year 2021 financial results....In February 2022, AcelRx was notified that it had met all requirements set by the U.S. Food and Drug Administration (FDA) with regards to the FDA Warning Letter regarding certain DSUVIA promotional materials, dated February 11, 2021, and a Closeout Letter is expected in Q1 2022....8,960 units of DSUVIA were sold in the fourth quarter of 2021, compared to 3,710 units in the third quarter of 2021..."

Commercial • FDA event • CNS Disorders • Pain

AcelRx Pharmaceuticals Announces Publication of an Article Highlighting the Utility of the Sufentanil Sublingual Tablet in Pain Medicine Procedures (PRNewswire) - "AcelRx Pharmaceuticals, Inc...today announced the publication of an article reviewing the use of sufentanil sublingual tablet (SST; DSUVIA®) for pain medicine procedures by lead author Dr. Sarang Koushik in Current Pain and Headache Reports."

Clinical • CNS Disorders • Pain

AcelRx Pharmaceuticals Announces Publication of Clinical Data Showing Reduced Hospital Length of Stay and Reduced Opioid Utilization with Use of Sublingual Sufentanil in Total Joint Replacement Surgery (PRNewswire) - "AcelRx Pharmaceuticals, Inc...today announced the publication of real-world data in patients undergoing total hip or total knee replacement showing decreased hospital length of stay and decreased opioid utilization following administration of sublingual sufentanil to manage acute pain compared to standard IV opioids. The article was published in the Journal of Orthopaedic Experience and Innovation....A total of 110 patients were evaluated, with 53 patients prospectively treated with SST and 57 patients in the historical comparator group. The SST group utilized approximately 30% less total morphine milligram equivalents throughout their stay (17.8 ± 2.4 vs 25.0 ± 3.3 for control patients [P < .05])."

Clinical data • CNS Disorders • Pain

The Newest Battlefield Opioid, Sublingual Sufentanil: A Proposal to Refine Opioid Usage in the U.S. Military. (PubMed, Mil Med) - "Furthermore, the DoD continually refined opioid protocols for acute pain on the battlefield, evolving from intramuscular morphine to intravenous morphine administration to oral transmucosal fentanyl citrate lollipops (Actiq) to finally sublingual sufentanil tablets (SSTs, Dsuvia). Accordingly, this commentary aims to (1) review the evolution of opioid use on the battlefield and discuss the medical benefits and limitations of SSTs in acute trauma settings, (2) highlight the importance of chronic pain management post-deployment through evidence-based non-opioid modalities, and (3) explore avenues of future research. Ultimately, we propose that SSTs are an important improvement from existing battlefield opioids and that refining, not abandoning, opioid usage will be key to effectively managing pain in the military."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Mood Disorders • Pain • Psychiatry

Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment (clinicaltrials.gov) - P4; N=30; Recruiting; Sponsor: Montefiore Medical Center; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Pain

"$ACRX AcelRx Announces an Investigator-Initiated Study of DSUVIA® for Use in Same-Day Total Joint Replacement https://t.co/XpLfUkZkE3" (@stock_titan)

Orthopedics

Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center (clinicaltrials.gov) - P4; N=53; Completed; Sponsor: University of Minnesota; Recruiting ➔ Completed; N=40 ➔ 53

Enrollment change • Trial completion • Anesthesia • Pain

AcelRx Announces an Investigator-Initiated Study of DSUVIA in Patients Undergoing Plastic Surgery Procedures (PRNewswire) - "AcelRx Pharmaceuticals...today announced an agreement with Newport Plastic and Reconstructive Surgery Associates for an investigator-initiated study analyzing data from the historical use of DSUVIA (sufentanil sublingual tablet 30 mcg) for various same-day plastic surgery procedures...'We look forward to the analysis and publication of his clinical data with DSUVIA as plastic surgeons are eager for alternatives to IV opioids when treating moderate-to-severe acute pain.'"

Licensing / partnership • CNS Disorders • Pain

Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment (clinicaltrials.gov) - P4; N=30; Not yet recruiting; Sponsor: Montefiore Medical Center

Clinical • New P4 trial • Pain

"$ACRX AcelRx Announces an Investigator-Initiated Study of DSUVIA® in Cardiac Surgery Enhanced Recovery Regimen https://t.co/xp84VxLD2T" (@stock_titan)

Cardiovascular