Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SKY0402 · 13 trials · 8 indications
To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain and respond to the following question: "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?"
The AUC of the NRS-R pain intensity scores from time 0 through 24 hours The subject was to rest for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?"
The subject's pain intensity was assessed with activity (NRS-A), while actively flexing the involved knee from the maximum extension point to the maximum flexion point possible. The subject responded to the following question, "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?"
Assessments of postoperative pain were conducted through 96 hours and included pain intensity at rest (NRS-R) and with activity (NRS-A). The prescribed activity was to consist of raising the arm, in full extension at the elbow and wrist, to a position parallel with the axis of the torso. Pain intensity was scored on an 11-point scale, where 0 = no pain and 10 = worst possible pain.
To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question: "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?"
The subject's pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?"
The subject's pain intensity was to be assessed with activity (NRS-A) after actively flexing the involved knee to the maximum flexion point possible. The subject was asked to respond to the following question: "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?"
The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical pain.
The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical wound pain
A dynamometer was used to measure the force produced during a maximum voluntary isometric contraction (MVIC) in a seated position with the knees flexed at 90°. The dynamometer was placed on the anterior tibia perpendicular to the tibial crest, just proximal to the medial malleolus. Subjects were asked to take 2 seconds to come to maximum effort contracting the ipsilateral quadriceps femoris, maintain this effort for 5 seconds, and then relax. The measurements immediately before study drug administration were designated baseline, and all subsequent are expressed as a percentage of the baseline.
| Arm | Type | Description |
|---|---|---|
| SKY0402 | EXPERIMENTAL | During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound. |
| Placebo | PLACEBO_COMPARATOR | During the hemorrhoidectomy, 30cc Placebo injected into the wound. |
| Bupivacaine HCl | ACTIVE_COMPARATOR | 100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration. |
| Low-dose SKY0402 + bupivacaine HCl | ACTIVE_COMPARATOR | Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402 |
| Mid-dose SKY0402 + bupivacaine HCl | ACTIVE_COMPARATOR | Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402 |
| SKY0402 high dose | EXPERIMENTAL | SKY0402, single administration |
| SKY0402 middle dose | EXPERIMENTAL | SKY0402, single administration |
| SKY0402 low dose | EXPERIMENTAL | SKY0402, single administration |
| Bupivacaine HCl 105mg | ACTIVE_COMPARATOR | Bupivacaine HCl given during hernia repair |
| Nerve Block | EXPERIMENTAL | The dominant side (left or right) will be randomized to one of two treatment groups: the higher or lower concentration of the local anesthetic EXPAREL. The non-dominant contralateral side will receive the other possible treatment. The volume of each and every single-injection femoral nerve block will be 30 mL (standard for femoral nerve blocks is 30-40 mL).3 Since volume will remain constant, we will vary the dose of EXPAREL by varying concentration (volume x concentration = dose). Of note, EXPAREL may be mixed with normal saline to vary the concentration. Randomization will be based on computer-generated codes. Randomization will be in blocks of two, and stratified by sex. |
| Moxifloxacin tablet | ACTIVE_COMPARATOR | - |
| Placebo tablet | EXPERIMENTAL | - |
| SKY0402 300mg | EXPERIMENTAL | - |
| SKY0402 450mg | EXPERIMENTAL | - |
| Placebo injection | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SKY0402 | DRUG | During the operation, 30cc of SKY0402 are injected into the wound. |
| Placebo | DRUG | During the hemorrhoidectomy, 30cc Placebo injected into the wound. |
| Bupivacaine HCl | DRUG | 100 mg Bupivacaine HCl |
| SKY0402 + bupivacaine HCl | DRUG | Low-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket |
| Mid-dose SKY0402 + bupivacaine HCl | DRUG | Mid-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket |
| Moxifloxacin 400mg | DRUG | - |
| Placebo injection | DRUG | - |
| Placebo tablet | DRUG | - |
Inclusion Criteria: * Age \> 18 years of age at the Screening visit * American Society of Anesthesiologists (ASA) class 1-3 * Scheduled to have a two or three column excisional hemorrhoidectomy under general anesthesia using the Milligan-Morgan technique * For female subjects, surgically sterile or...
SKY0402 is an investigational small molecule being developed for postoperative pain management. It has been studied in clinical trials for conditions including inguinal hernia repair, hemorrhoids, bunion surgery, and postoperative pain. The drug is administered by local infiltration to manage pain following surgical procedures.
SKY0402 is being developed by Pacira BioSciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol PCRX. The company is conducting clinical research on this investigational drug for postoperative pain management indications.
SKY0402 is in Phase 3 clinical development. It has completed seven clinical trials with a total enrollment of 727 participants. All trials are completed, with no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities.
SKY0402 has completed seven clinical trials, including NCT00485667, a Phase 1 thorough QT study in healthy volunteers in the United Kingdom; NCT00806806, a Phase 1 onset of action study in healthy volunteers in the United States; NCT01203644, a Phase 2 study in inguinal hernia repair; and NCT01349140, a Phase 1 dose-response study for femoral nerve blocks.
SKY0402 is associated with EXPAREL, as one clinical trial is titled 'EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks.' The drug is being developed by Pacira BioSciences, which markets EXPAREL as a postoperative pain management product.