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Also known as Bupivacaine TTS (Bupivacaine Patch)
Bupivacaine TTS · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Bupivacaine TTS | EXPERIMENTAL | - |
| Placebo patch | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Bupivacaine TTS (Bupivacaine Patch) | DRUG | Contains bupivacaine base, in a flexible and rectangular-shaped, transdermal, delivery system. Three patches applied to the lower back every 72 hours for 12 weeks. |
| Placebo patch | DRUG | Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks. |
Inclusion Criteria: 1. Diagnosis of chronic low back pain for more than 3 months 2. If taking non-steroidal anti-inflammatory drugs or non-opioid analgesics, must be on a regular, scheduled dose for at least 4 weeks prior to the first visit and intend to remain on a stable dose of these agents for ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE3 | Camlipixant |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE2 | Haduvio (nalbuphine ER) |
Bupivacaine TTS is an investigational transdermal patch being developed for the treatment of chronic low back pain. It is designed to deliver bupivacaine through the skin as a non-invasive option for patients with persistent low back pain. It is not approved and remains in clinical development.
Bupivacaine TTS targets SCN4A, a voltage-gated sodium channel. Bupivacaine acts as a sodium channel blocker, which interferes with nerve signal conduction and is the basis for its local anesthetic and analgesic activity. The transdermal patch formulation is intended to provide sustained delivery of bupivacaine at the site of pain.
Bupivacaine TTS is being developed by DURECT Corporation, which trades on the Nasdaq under the ticker DRRX. DURECT is the sponsor of the clinical program evaluating the patch in chronic low back pain.
Bupivacaine TTS is in Phase 2 development. It is an investigational product and has not been approved by the FDA. The completed Phase 2 trial enrolled 263 patients with chronic low back pain, and no trials of this asset are currently listed as active.
Bupivacaine TTS has been studied in one clinical trial, NCT01096966, titled Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain. The Phase 2 trial was randomized, double-blind, placebo-controlled, completed, and enrolled 263 patients in the United States.
Yes. Bupivacaine TTS is also known as the bupivacaine patch. Both names refer to the same transdermal formulation of bupivacaine developed by DURECT Corporation for chronic low back pain. Searches for either name point to the same investigational asset.