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Development of a novel sustained release local anesthetic wound dressing for partial-thickness dermal injuries

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43GM142413-01A1
Agency Tracking Number: R43GM142413
Amount: $263,051.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 300
Solicitation Number: PA20-272
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-30
Award End Date (Contract End Date): 2022-06-29
Small Business Information
825 N 300 W STE 300
Salt Lake City, UT 84103-1459
United States
DUNS: 081318998
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (754) 244-8906
Business Contact
Phone: (754) 244-8906
Research Institution

The pain associated with superficial and partial-thickness dermal wounds can be intense and sustained
throughout the healing process. Inadequate pain management can impair wound healing, prolong
hospitalization, decrease patient satisfaction and increase healthcare costs. Due to limited treatment options and
the short duration of current local anesthetic formulations, opioid analgesics are the mainstay of pain
management for these patients despite their association with a variety of adverse events. Consequently, pain
from dermal injury is not optimally treated because providers lack a safe and effective alternative to opioids for
their patients.
109 Therapeutics is developing BUPIVADERM, a novel, drug-delivering wound dressing that provides sustained
bupivacaine delivery to partial-thickness dermal wounds in a predictive and extended manner. The novel wound
dressing will be a first-of-kind wound dressing that provides both the wound healing properties of the traditional
moist wound dressings clinically available, but with the added functionality of safe and effective analgesia for 5
days. The dressing will only need to be applied one time and non-traumatically peels off once re-epithelialization
occurs, thus eliminating the need for dressing changes or analgesic redosing. The novel wound dressing will
provide significant value to patients, clinicians, and society alike by increasing patient satisfaction, mitigating the
use of opioids, and reducing cost of care in the treatment of partial-thickness dermal wounds.
In preliminary experiments, we have demonstrated the ability to fabricate bupivacaine-loaded microporous
polymer films that have the same dimensions and physicochemical properties of the current gold standard moist
wound dressings, but with the added ability to provide 5 days of sustained bupivacaine delivery. The proposed
work will seek to demonstrate in vivo technical feasibility of the novel wound dressing by validating the safety,
wound healing and analgesic efficacy of our prototype in a standardized porcine dermal injury model. Analgesic
efficacy and duration will be assessed by von Frey assay of mechanical sensitivity, wound healing will be
assessed via gross and histological assays, and systemic toxicity will be assessed via pharmacokinetic
assessment. The proposed Phase I work will demonstrate that our novel sustained bupivacaine release wound
dressing can provide 5 days of safe and effective non-opioid analgesia and non-inferior wound healing in a
clinically relevant pre-clinical model, which would warrant continuation of commercialization efforts.

* Information listed above is at the time of submission. *

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