SBG004 (bupivacaine extended-release solution) has promise to be a potential best-in-class local anesthetic, providing potent analgesia for over 72 hours in an established porcine skin and muscle incision model (see below). SB Gel’s unique temperature-responsiveness allows the material to be applied as a liquid but then to act as an ultra-high viscosity gel in situ which retains the dose at the site and allows slow, diffusion-based release of bupivacaine. Established biomaterial technologies have key drawbacks for local anesthetic release, including poor retention in situ, poorly timed release, or generation of acidic byproducts which can suppress the activity of local anesthetics by limiting their penetration into neurons. SBG004 avoids all of these limitations.
- SBG004 has potential for:
- Covering the full duration of moderate-to-severe pain
- Enabling reduction in opioid prescription and use
- Enabling safer and more reliable recovery and discharge to self-care
- Formulation advantages
- Local analgesia lasting over 72 hours
- Reduces dose-limiting peak drug levels associated with systemic toxicity
- Water-based – no solvents or chemical reaction
- Dissolves fully after drug release, with minimal acid generation or low molecular weight byproducts
SBG004 Provides Analgesia For Up to Five Days
Mean force tolerated 0.5 cm from the incision following skin and muscle incision in minipigs (n=8, mean ± SEM). All treatments were dosed by subcutaneous injection. Methods were adapted from Castel et al. Eur J Pain, 2014. Double asterisk (**) denotes p < 0.05 vs. saline and liposomal bupivacaine.
Status and Development Plans
SBG004 is currently in preclinical development. In clinical studies, we plan to evaluate SBG004 in model hard and soft tissue procedures similar to those used to support approval of other long acting local anesthetics. We are currently seeking to raise capital to support the development of SBG004 through Phase 2. For additional information on SBG004 and our development plans, please contact us.