Research conducted with this grant will further expand and enhance the company’s dental bone graft solution with local delivery of non-opioid pain medications to reduce the need for prescription opioids in conjunction with wisdom tooth extractions.
LOWELL, Mass.–(BUSINESS WIRE)– RevBio, Inc.announced that it received a grant from National Institutes of Health through the Long-Term Initiative Helping to End Addiction or NIH HEAL Initiative, to improve strategies for the prevention and treatment of opioid abuse and addiction. This $2 million Phase II Small Business Innovation Research (SBIR) grant (2R44DE029369-02) will fund the preclinical development of a dental bone graft formulation involving the release of a topically active non-opioid analgesic. This product is intended to be used to fill extraction sites and alleviate post-operative pain after wisdom teeth removal.
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“The data show that there is a statistically significant increase in the absolute risk of persistent opioid use and abuse after a single opioid treatment prescribed after wisdom tooth extractions,” said George Kay, DMD, MMSc, chief scientific officer and co-principal researcher at RevBio. The grant will fund the preclinical development of a dental bone graft formulation that will include the release of topically active non-opioid pain medications. (Photo: Business Wire)
“The data show that there is a statistically significant increase in the absolute risk of persistent opioid use and abuse after a single opioid treatment prescribed after wisdom tooth extractions,” said George Kay, DMD, MMSc, Chief Scientific Officer and co-principal investigator. of RevBio. About 10 million third molars (wisdom teeth) are removed annually in the United States.1
“Preliminary studies have shown that medication can be incorporated into the patented Tetranite bone biomaterial and released over time,” said Rahul Jadia, PhD, who is RevBio’s R&D Director of Technology Development and co-principal investigator for this grant. the profile of a target drug can be adjusted to create an ideal time-dose curve.’ Previously, both Drs. Kay and Jadia served as co-principal investigators on a Phase I SBIR grant (1R43DE029369-01) who investigated drug release for pain management from RevBio’s self-adhesive dental bone scaffold. Their research was highlighted in a story on National Institutes of Health HEAL Initiative website.
Opioid use disorder (OUD) is a major problem in the US, with 107,622 overdose deaths in 2021.
2 A major contributor to widespread OUD is the postoperative prescription of opioids after routine dental procedures such as wisdom tooth extraction.3 Finding an alternative to prescribing opioids is extremely important, as most wisdom tooth extraction patients are between the ages of 13 and 30 and are highly susceptible to OUD. A recent study conducted on 70,942 patients showed that approximately 79.9% of patients filled a perioperative opioid prescription for wisdom tooth extractions.4 In a similar study conducted in a larger sample of 754,002 people, there was a statistically significant 6.8% absolute increase in persistent opioid use and a 5.4% increase in subsequent opioid abuse diagnosis.5 As a result, there is an urgent need to develop non-opioid-based acute pain management strategies for patients undergoing external oral surgery, preferably through local drug delivery to target tissues.
In addition to the pain from the surgery, 10% of all wisdom tooth extraction sites develop a painful condition known as a “dry socket” which can occur three to four days after a wisdom tooth is removed.6,7 This condition develops when the blood clot that should form after a tooth extraction breaks off or dissolves before the wound heals, exposing the underlying bones and nerves.
“Not only will Tetranite deliver the pain medication locally, avoiding the need for a potentially addictive prescription, but the material will clog the socket and reduce the chance of dry socket,” said Dr. Kay.
This grant complements existing funding RevBio has received from the NIH-funded Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center (U24DE0294162), which was created to improve the translation of promising tissue engineering and regenerative medicine technologies for dental , oral and clinical craniofacial practice. This also extends to a Phase II SBIR grant (1R44DE032564-01) received by RevBio from the National Institute of Dental and Craniofacial Research (NIDCR).
About RevBio, Inc.
RevBio, Inc., is a clinical-stage medical device company engaged in the development and commercialization of a proprietary, synthetic, injectable, self-setting, and osteoconductive bone adhesive biomaterial called Tetranite®. The company is initially developing this technology for use in the dental, cranial and broader orthopedic market as well as applications in the animal health market. RevBio’s Tetranite technology is not yet approved for commercial use.
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1 Centers for Disease Control and Prevention. “US overdose deaths in 2021 halved from 2020 – but still up 15%”. Retrieved August 16 (2022): 2022.
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2 Ibid.
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3 Wampler, Anne E. “Opioids and Dentistry.” Pacific Journal of Health 4, no. 1 (2021): 1.
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4 Ibid.
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5 Richard, Patrick, Mark R. Bauer, Natalie Moresco, Regine Walker, Diana Bowser, Demarcio Reed, and Mary Jo Larson. “Opioid prescribing for surgical dental procedures in dental clinics of military treatment facilities.” The Journal of the American Dental Association 152, no. 2 (2021): 94-104.
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6 Akinbami, Babatunde O. and Thikan Godspower. “Dry cavity: incidence, clinical features and predisposing factors.” International Journal of Dentistry 2014 (2014).
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7 Coulthard, Paul, Edmund Bailey, Marco Esposito, Susan Furness, Tara F. Renton, and Helen V. Worthington. “Surgical techniques for removal of mandibular wisdom teeth”. Cochrane Database of Systematic Reviews 7 (2014).
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Source: RevBio, Inc.
“The data show that there is a statistically significant increase in the absolute risk of persistent opioid use and abuse after a single opioid regimen prescribed after wisdom teeth extractions,” said George Kay, DMD, MMSc, Scientific Director and co-principal investigator. of RevBio. The grant will fund the preclinical development of a dental bone graft formulation involving the release of topically acting non-opioid pain medications. (Photo: Business Wire)
