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Synera · 1 trial · 3 indications
The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS \<3 is considered as patients with no or minor pain and would be compared between 2 groups.
The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS =0 is considered as patients with no pain and would also be compared between 2 groups.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch |
| Arm 2 | EXPERIMENTAL | First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch |
| Name | Type | Description |
|---|---|---|
| Synera (lidocaine 70mg/tetracaine 70mg) | DRUG | All subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second. |
Inclusion Criteria: * Patients with any tumor type where treatment is received through venipuncture or any procedure that is needle based or who require regular pharmacokinetic (PK) study. * Is 18 years of age or older. * Patients expected to undergo the first venipuncture procedure within 5 workin...
Synera is an investigational small molecule being developed for the treatment of pain. It has been studied in the context of venipuncture pain, particularly in patients requiring phlebotomy and those in palliative care. The drug is currently in Phase 2 clinical development.
Synera is being developed by McKesson Corporation, a company publicly traded under the ticker symbol MCK. The drug is currently in Phase 2 clinical development for the treatment of pain.
Synera is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, controlled study. The drug is investigational and has not been approved by regulatory authorities.
Synera has one completed clinical trial, identified as NCT01744197. This Phase 2 study, titled 'Synera Venipuncture Pain,' enrolled 61 participants in the United States and evaluated the drug for pain associated with venipuncture, phlebotomy, and palliative care.
Synera is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of pain. The drug has completed one clinical trial, but it remains under investigation and has not received regulatory approval.