Science in the News
New Intranasally 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 Kovanaze™ 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 been reported.1
- St. Renatus L.L.C. Kovanaze™ (tetracaine HCl and oxymetazoline HCl) nasal spray (rev. 6/2016). Accessed July 14, 2016.
- 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.
- U.S. Food and Drug Administration. FDA NDA Approval Letter: Kovanaze (NDA 208032). Accessed July 14, 2016.
Prepared by: Center for Scientific Information, ADA Science Institute
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