Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sufentanil NanoTab PCA System · 4 trials · 3 indications
SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. Range of SPID48 scores were -239 to 417. Time-weighted SPID48 = ∑ \[T(i) - T(i-1)\] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours
Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control
SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326. Time-weighted SPID48 = ∑ \[T(i) - T(i-1)\] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours. Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one "active" patient receiving placebo inadvertently.
Percent of patients who completed the study without a device failure. A device failure is defined as the failure to dispense a NanoTab, dispensing more than one NanoTab, or dispensing a broken NanoTab. Device failures were monitored and reported by study staff.
| Arm | Type | Description |
|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | EXPERIMENTAL | - |
| Placebo Sufentanil NanoTab PCA System | PLACEBO_COMPARATOR | - |
| morphine IV PCA | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | DRUG | 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for at least 48 hours. Patients may elect to remain in study for up to 72 hours. |
| Placebo Sufentanil NanoTab PCA System | DRUG | Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for at least 48 hours. Patients may elect to remain in study for up to 72 hours. |
| morphine IV PCA | DRUG | 1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours |
Inclusion Criteria: * Male or female patients who are 18 years of age or older * Patients who are scheduled for an elective cemented or uncemented total unilateral knee replacement or total unilateral hip replacement, under general or spinal anesthesia that does not include use of an intrathecal op...
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The Sufentanil NanoTab PCA System is used for the treatment of post-operative pain, including pain after knee or hip replacement surgery and open abdominal surgery. It is a small molecule drug-device combination being developed by Talphera, Inc. for acute pain management in the post-operative setting.
The Sufentanil NanoTab PCA System is being developed by Talphera, Inc., a biopharmaceutical company. Talphera is publicly traded under the ticker symbol TLPH. The system is designed for patient-controlled analgesia to manage acute post-operative pain.
The Sufentanil NanoTab PCA System is in Phase 2 clinical development. While some completed trials were Phase 3, the current development stage is Phase 2. It is an investigational product and has not been approved by the FDA for commercial use.
The Sufentanil NanoTab PCA System has been studied in multiple completed trials. NCT00859313 was a Phase 2 open-label study in patients undergoing knee replacement. NCT01539538, NCT01539642, and NCT01660763 were Phase 3 trials evaluating the system for post-operative pain after abdominal, knee, or hip surgery.
Yes, the Sufentanil NanoTab PCA System is also known as Zalviso. Clinical trial records reference the Sufentanil NanoTab PCA System/15 mcg as Zalviso. This alternative name appears in the titles of Phase 3 trials evaluating the system for post-operative pain management.
The Sufentanil NanoTab PCA System delivers sufentanil, an opioid analgesic, through a patient-controlled analgesia system. Sufentanil acts on opioid receptors to provide pain relief. The system allows patients to self-administer small doses of the medication to manage acute post-operative pain.