Safety and Efficacy of a Novel Nasal Spray for Maxillary Dental Anesthesia

Abstract

This study examines the efficacy, safety, and tolerability of a nasal spray to induce anesthesia of maxillary teeth. Forty-five healthy adults requiring restoration of one maxillary tooth were randomized in a 1:2 ratio to receive (1) an intra-oral lidocaine-epinephrine injection with buffered saline nasal spray bilaterally, or (2) a tetracaine hydrochloride-oxymetazoline hydrochloride nasal spray bilaterally with sham injection. Primary endpoints were use of rescue anesthesia and patient global pain assessment. Secondary outcomes included vital sign changes, soft-tissue anesthesia, and treatment-emergent adverse events. In intent-to-treat analysis, 25 of 30 patients given nasal spray (83.3%) did not require rescue anesthesia. Proportion of anesthesia successes for nasal spray was significantly different from the hypothesized placebo anesthesia success of 30% (one-sided p value < .0001 by exact binomial test). Mean duration of soft-tissue anesthesia did not differ significantly by treatment for 3 of 4 sites assessed. No serious adverse events or systemic effects were observed. Tetracaine hydrochloride-oxymetazoline nasal spray appears to provide adequate and safe anesthesia for the majority of maxillary dental procedures. Based on the results from this Phase 2 study, pivotal trials are warranted to validate these findings in an expanded patient population.

Comparison of 3 intranasal mists for anesthetizing maxillary teeth in adults

“…Mean maximum changes in blood pressure were significantly greater in the K305 group versus the placebo group, counter to phase 2 findings. 25 These differences could be attributed to the mechanism of action of oxymetazoline, a sympathomimetic drug that selectively agonizes a1and (partly) a2-adrenergic receptors, causing vasoconstriction. 28 At the same time, the placebo group showed marked decreases in blood pressure, possibly related to the more frequent use of rescue (articaine or epinephrine) injections in this group.…”

“…We expected the success rate to be approximately 83% with K305 spray. 25 Because each pairwise comparison was a 1-tailed test, we set the type I error (a) for each test at 0.025 (that is, 0.05/2). We determined that the study results were to be declared positive only if we could show that K305 was superior to both tetracaine-only and placebo sprays.…”

“…19 In a phase 2 study of combination tetracaineoxymetazoline spray, 83% of patients receiving the spray required no rescue anesthesia via lidocaine injection. 25 Among procedures involving maxillary nonmolar teeth, the success rate was even higher (90%), and the spray was safe and well tolerated. 25 Initial phase 3 testing showed similar success rates-88% for the combination spray versus 28% for placebo spray.…”

“…25 Among procedures involving maxillary nonmolar teeth, the success rate was even higher (90%), and the spray was safe and well tolerated. 25 Initial phase 3 testing showed similar success rates-88% for the combination spray versus 28% for placebo spray. 26 The objective of this phase 3 study was to determine the efficacy and safety of combination tetracaineoxymetazoline nasal spray (K305) compared with an active control (tetracaine-only spray) and a placebo spray for anesthetizing maxillary teeth in adults.…”

Advances in Local Anaesthesia: A Paediatric overview

“…A study published May 20, 2013 in the Journal of Dental Research indicates that the experimental nasal spray may be equally effective in anesthesia within the jaw as the conventional injections with lidocaine. 6 Spray which had been developed by St. Renatus of Fort Collins, Colorado has passed the third phase of the research, giving hope to obtain the approval of the FDA very soon. Its unique composition was inspired by a mixture of tetracaine hydrochloride and oxymetazoline used in otolaryngology.…”