July 3, 2024
Sonoran Biosciences Reports Publication of Positive Results in a Knee Surgery Model of Postoperative Pain
TEMPE, Ariz., Jul 3, 2024 — Sonoran Biosciences (“Sonoran” or “Company”), a preclinical-stage pharmaceutical company developing innovative hospital based products for the treatment of postoperative pain and surgical site infection, announced today the publication of additional results related to the Company’s product SBG004 (bupivacaine extended-release gel-forming solution) for treatment of postoperative pain. SBG004 is designed to provide extended release of bupivacaine, reducing pain without the use of opioids. The manuscript, published today in the journal Pharmaceuticals, reports evaluation of analgesic efficacy in a new rabbit knee surgery model and pharmacokinetics of released bupivacaine following injection in or around the knee.
In the analgesia study, rabbits underwent knee surgery and were treated with SBG004, saline as a negative control, or multiple active controls (liposomal bupivacaine-based cocktail, polyorthoester bupivacaine-meloxicam, or ropivacaine-based cocktail). Pain was assessed by scoring weight-bearing on the operated limb during video-recorded large steps without an observer in the room. A rabbit was counted as weight-bearing if at least two of three blinded observers scored at least half the large steps as weight-bearing on the operated limb.
Rabbits receiving high-dose SBG004 had excellent outcomes throughout the study, with a majority of rabbits weight-bearing at every time point from 4-72 hr and an overall 71% weight-bearing rate. During the period from 24-72 hr after free bupivacaine wears off, rabbits receiving high-dose SBG004 had the best outcomes of any group tested. During this period, the fraction of rabbits weight-bearing was 71% for high dose SBG004, compared to 45% for polyorthoester bupivacaine-meloxicam, 41% for ropivacaine cocktail, 36% for liposomal bupivacaine cocktail, and 37% for saline. At 24 hr, only high dose SBG004 reached significance versus saline. Recovery of the negative control group rendered the study underpowered to detect statistical differences at 48 hr and later.
Systemic bupivacaine exposure lasted for at least 7 days for periarticular SBG004 compared to 2-4 days for periarticular liposomal bupivacaine, indicating a longer duration of bupivacaine release from SBG004.
The publication may be accessed at the following link: Extended Release of Bupivacaine from Temperature-Responsive PNDJ Hydrogels Improves Postoperative Weight-Bearing in Rabbits Following Knee Surgery
Research reported in this publication was supported by the National Institute of General Medical Sciences of the National Institutes of Health under Award Number R43GM145020. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About Sonoran Biosciences, Inc.
Sonoran Biosciences is a preclinical-stage pharmaceutical company leveraging its proprietary drug delivery technology to develop innovative hospital-based products for the treatment of postoperative pain and prevention of surgical site infections. Sonoran’s products are based on its proprietary SB Gel, an injectable carrier that forms a solid gel in the body, releases drugs over multiple days, and dissolves after the drugs are released. Sonoran’s lead products are SBG004, a long-acting formulation of bupivacaine, and SBG003, a fixed-dose combination of tobramycin and vancomycin for prevention of surgical site infection.