Science in the News

New Intransally Administered, Needleless Dental Anesthetic Approved by the U.S. Food and Drug Administration

July 15, 2016

On June 29, 2016, the U.S. Food and Drug Administration approved Kovanaze™ (St. Renatus, L.L.C.), a needleless, intranasally administered spray combination of the ester anesthetic tetracaine HCl plus the vasoconstrictor oxymetazoline HCl (6 mg/0.1 mg per 0.2 mL) for regional maxillary anesthesia.1-3 Kovanaze™ is indicated for regional pulpal anesthesia when performing a restorative procedure on teeth 4 through 13 and A through J in adults and children who weigh 40 kg (88 lbs) or more.1, 3 The drug is supplied as a prefilled, single-use sprayer that delivers 6 mg tetracaine HCl and 0.1 mg oxymetazoline HCl (equivalent to 5.27 mg tetracaine and 0.088 mg oxymetazoline) in each 0.2 mL spray.1

Kovanaze™ should be administered intranasally ipsilateral (on the same side) to the maxillary tooth on which the dental procedure will be performed. Recommended doses1 are as follows:

Adults (≥ 18 years old)	*2 sprays (0.2 mL per spray), 4 to 5 minutes apart *1 additional spray (0.2 mL) if adequate anesthesia has not been achieved 10 minutes after the second spray
Children who weigh 40 kg or more	2 sprays (0.2 mL per spray), 4 to 5 minutes apart

Contraindications to Kovanazee™ include:

Known hypersensitivity to tetracaine, benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or any other component of the product.1 The most common adverse reactions occurring in 10% or more of patients include rhinorrhea, nasal congestion, lacrimation increased, nasal discomfort, and oropharyngeal pain. Transient, asymptomatic elevations in systolic blood pressure (≥25 mm Hg from baseline) and diastolic blood pressures (≥15 mm Hg from baseline) have also been reported.

References

1. St. Renatus L.L.C. Kovanaze™ (tetracaine HCl and oxymetazoline HCl) nasal spray (rev. 6/2016). Accessed July 14, 2016.

2. St. Renatus L.L.C. Press release: St. Renatus, LLC Announces FDA Approval of KOVANAZE™ (tetracaine HCL and oxymetazoline HCl) Nasal Spray for Use (posted July 12, 2016). Accessed July 14, 2016.

3. U.S. Food and Drug Administration. FDA NDA Approval Letter: Kovanaze (NDA 208032). Accessed July 14, 2016.

Science in the News

Caries Risk Assessment Can Predict Future Caries Risk in Children 6 Years of Age or Younger

July 28, 2016

A retrospective analysis1 of electronic patient records (n=3,810 baseline; n=1,315 with follow-up; years 2009 through 2015) from a university pediatric dental clinic showed that formal caries risk assessment was associated with prediction of future caries risk in patients 6 years of age or younger. The 17 caries risk assessment items are listed in the following table.

Contraindications to Kovanaze™ include:

The nine caries risk assessment items presented in the table above were statistically significant indicators of student/resident practitioner designation of caries high risk. In turn, practitioner-assigned baseline caries risk designation was strongly associated with clinically evident tooth decay at follow-up. Of all caries risk assessment items, only clinically evident decay or white spots at baseline was independently and significantly associated with evident decay at follow-up. Limitations of the analysis identified by the authors included how well the findings from the “predominantly urban, low-income population from a fluoridated, high-resource area” could be generalized to other types of populations and whether the behaviors and assessments of the student and resident dental providers at the university-based clinic reflected those of more established dentists or trainees in other university settings.

The ADA has recently updated and expanded the Oral Health Topic resource page on caries risk assessment and management to include discussion of various methods and tools for caries risk assessment, including the ADA Caries Classification System (CCS), and management.

References

1. Chaffee BW, Featherstone JD, Gansky SA, Cheng J, Zhan L. Caries Risk Assessment Item Importance: Risk Designation and Caries Status in Children under Age 6. JDR Clin Trans Res 2016;1(2):131-42.