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...
Top 2 of 26 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE2 | LY4515100 |
| Pfizer Inc. | PFE | 1 | N/A | Palbociclib |
Sufentanil NanoTab PCA System is an investigational small molecule therapy being developed for the treatment of postoperative pain. It is designed as a patient-controlled analgesia system delivering sufentanil, an opioid analgesic, and is being developed by Talphera, Inc. (ticker TLPH). It has been studied in patients recovering from knee or hip replacement, open abdominal surgery, and other procedures.
Sufentanil NanoTab PCA System is being developed for the treatment of postoperative pain, including post operative pain following knee or hip replacement surgery and open abdominal surgery. It is intended to provide patient-controlled analgesia in the acute postoperative setting. It remains investigational and is not approved for commercial use.
Sufentanil NanoTab PCA System targets OPRM1, the mu-opioid receptor. Sufentanil acts as an agonist at this receptor, which is the target class for this asset. This mechanism underlies its analgesic activity in postoperative pain. The system is a small molecule formulation of sufentanil delivered through a patient-controlled analgesia approach.
Sufentanil NanoTab PCA System is being developed by Talphera, Inc., which trades under the ticker TLPH. Talphera is the sponsor of the clinical program evaluating the asset in postoperative pain. The drug is also known as Sufentanil NanoTab PCA System/15 mcg.
Sufentanil NanoTab PCA System is in Phase 2 development according to its current development stage, though completed clinical trials have included Phase 3 studies. It is investigational and has not been approved by the FDA. The program includes three completed trials with a total enrollment of 948 participants.
Sufentanil NanoTab PCA System has been evaluated in completed trials including NCT01660763 in knee or hip replacement surgery, NCT01539642 in open abdominal surgery, NCT01539538 comparing it with intravenous morphine patient-controlled analgesia, and NCT00859313 in elective unilateral knee replacement. All listed trials are completed, with no active trials currently recruiting.