Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zalviso · 1 trial · 1 indication
The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points throughout the 24 hour period. The time-weighted SPID24 is the time-weighted summed PID over the 24-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.The scores ranged from - 72 to 204.
The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points and throughout the 48 hour period. The time-weighted SPID48 is the time-weighted summed PID over the 48-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.The scores ranged from -144 to 408.
The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points throughout the 72 hour period. The time-weighted SPID72 is the time-weighted summed PID over the 72-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. The scores ranged from -239 to 624.
Total pain relief over the 24-hour study period. A higher TOTPAR score means a greater relief in pain. Range of scores was from 0.00 to 96.00.
Total pain relief over the 48-hour study period. A higher TOTPAR score means a greater relief in pain. Range of scores was from 0.00 to 192.00.
Total pain relief over the 72-hour study period. A higher TOTPAR means a greater relief in pain. Range of scores was from 0.00 to 288.00.
At protocol-specified time points, the patient is asked to self-record his/her current level of pain on an 11-point numerical rating scale where 0 equals no pain and 10 equals the worst possible pain.
The PID at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. The higher the PID score, the lower the pain intensity. The scores ranged from - 239 to 624.
At protocol-specified time points, the patient is asked to self-record his/her current level of pain relief on 5-point numerical rating scale where 0 equaled no pain relief and 4 equaled complete pain relief. The baseline score references the baseline pain intensity score and the following timepoints reference pain relief scores.
Questionnaire completed by patients at the end of his/her participation in the study regarding the usability of Zalviso.
Questionnaire regarding the usability of Zalviso completed by HCPs who had set up at least 5 Zalviso Systems for patients
Average number of study drug doses used per hour, adjusting by treatment exposure time and study period
Supplemental opioid medication (2 mg IV morphine) was allowed in the first 30 minutes after the first on-demand dose of study drug had been administered, if necessary, to keep a patient comfortable. Otherwise, supplemental opioid medication (2 mg IV morphine, no more frequently than hourly) was allowed for pain due to ambulation or with the initiation of passive range of motion therapy throughout the remainder of the study.
| Arm | Type | Description |
|---|---|---|
| Zalviso™ 15 mcg | EXPERIMENTAL | Zalviso™(sufentanil sublingual tablet system) 15 mcg |
| Name | Type | Description |
|---|---|---|
| Zalviso™ 15 mcg | DRUG | Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours |
Inclusion Criteria: 1. Male or female patients who were 18 years of age or older. 2. Patients who were scheduled to undergo surgery under general or spinal anesthesia that does not include intrathecal opioids during the operation. 3. Patients classified as American Society of Anesthesiologists (ASA...
Zalviso is being developed for the treatment of moderate-to-severe acute pain. It is a small molecule therapeutic candidate studied in adult patients aged 18 years and older. The drug is not approved and remains in clinical development.
Zalviso is being developed by Talphera, Inc., which trades under the ticker TLPH. The company is responsible for the clinical program evaluating the drug in moderate-to-severe acute pain.
Zalviso is in Phase 3 clinical development. The program includes one completed Phase 3 trial, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA.
Zalviso has been evaluated in the Phase 3 trial NCT02662764, titled Study to Evaluate the Overall Performance of the Zalviso System (Sufentanil Sublingual Tablet System) 15 mcg. The trial enrolled 320 participants in the United States and is completed.