Delving into the Latest Updates on Oxymetazoline Hydrochloride/Tetracaine Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Kovacaine, Kovacaine Mist, KOVANAZE

+ [2]

Target

α1A-AR

Action

agonists

Mechanism

α1A-AR agonists(Alpha-1a adrenergic receptor agonists)

Therapeutic Areas

Other Diseases

Active Indication

Anesthesia

Inactive Indication-

Originator Organization

St. Renatus LLC

Active Organization

St. Renatus LLC

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (29 Jun 2016),

Anesthesia

Regulation-

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Structure/Sequence

Molecular FormulaC16H25ClN2O

InChIKeyBEEDODBODQVSIM-UHFFFAOYSA-N

CAS Registry2315-02-8

View All Structures (2)

An ideal local anesthetic would be effective, minimally reduce pulpal blood flow (PBF), and not require injection. This study compared the effects of 3% tetracaine plus 0.05% oxymetazoline nasal spray (Kovanaze; KNS) and injections using 2% lidocaine with 1:100,000 epinephrine (LE) or 3% mepivacaine plain (MP) on PBF, anesthetic efficacy, and participant preference.

Methods::

In a double-blind cross-over design, 20 subjects randomly received a test anesthetic and placebo at each of 3 visits (KNS/mock infiltration; mock nasal spray/LE; or mock nasal spray/MP). Nasal sprays and infiltration apical to a maxillary central incisor were delivered ipsilaterally. PBF was evaluated by laser Doppler flowmetry, and local anesthetic success was assessed with electric pulp testing. Postoperative pain levels, participant preference, and adverse events were also assessed.

Results::

LE injections demonstrated significant reductions in PBF at all time intervals compared with baseline (P < .05), whereas KNS and MP did not. Pulpal anesthesia success rates were higher for LE (85%) compared with MP (35%) and KNS (5%). Participants reported significantly higher postoperative pain levels for KNS compared with LE and MP. Additionally, KNS was the least preferred of the anesthetics administered and resulted in more reported adverse events.

Conclusion::

Although KNS showed no significant effect on PBF, it was not effective in achieving pulpal anesthesia as used in this study.

01 Mar 2019·Journal of endodonticsQ2 · MEDICINE

Anesthetic Efficacy of Intranasal 3% Tetracaine plus 0.05% Oxymetazoline (Kovanaze) in Maxillary Teeth

Q2 · MEDICINE

Article

Author: Beck, Mike ; Reader, Al ; Capetillo, Jeremy ; Drum, Melissa ; Nusstein, John ; Fowler, Sara

INTRODUCTION:

Needle-free anesthetic delivery is a promising alternative to traditional anesthetic routes of administration. The purpose of this study was to determine the patient preference for and pulpal anesthetic efficacy of a 3% tetracaine plus 0.05% oxymetazoline (Kovanaze) nasal spray in maxillary lateral incisors and first premolars.

METHODS:

Fifty adult subjects randomly received a 3% tetracaine plus 0.05% oxymetazoline (Kovanaze) nasal spray and mock infiltration or a mock nasal spray and 2% lidocaine with 1:100,000 epinephrine infiltration at the maxillary lateral incisor or first premolar in 2 appointments spaced at least 1 week apart in a single-blind cross-over design. Pulpal anesthesia was evaluated with an electric pulp tester. Side effects and subject preferences were also recorded.

RESULTS:

Anesthetic success was significantly lower for the Kovanaze nasal spray and mock infiltration (22%-37%) than for the mock nasal spray and lidocaine infiltration (89%-91%). Subjects reported more unwanted effects (nasal drainage and congestion, burning, pressure, and sinus congestion) after the Kovanaze nasal spray and mock infiltration than the mock spray and maxillary infiltration. Before participating in the study, more subjects (56%) preferred the nasal spray route versus a standard infiltration (44%). After experiencing both routes of administration, 100% of subjects preferred the standard infiltration.

CONCLUSIONS:

The 3% tetracaine plus 0.05% oxymetazoline (Kovanaze) nasal spray provided significantly less successful pulpal anesthesia than the lidocaine infiltration, was less preferable, and caused more unwanted effects.

100 Deals associated with Oxymetazoline Hydrochloride/Tetracaine Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	N01BA53	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Anesthesia	United States	St. Renatus LLC	29 Jun 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03962634 (CTgov)	Phase 2	Periapical Periodontitis \| Dental Caries	3	Kovanaze Nasal Spray (Kovanaze Nasal Spray (Pediatrics))	eohrghkozl(ygtcadsqtv) = mgloucywcj tomcdvgcsz (xhdhiyepjj, xponzugsgi - tqmfferbgi) View more	-	19 Nov 2020
				Articaine Injection (Articaine Injections (Pediatrics))	eohrghkozl(ygtcadsqtv) = vbyecuxsoy tomcdvgcsz (xhdhiyepjj, hwqlirgagc - xestjpketc) View more
NCT01701505 (CTgov)	Phase 2	Anesthesia	48	400uL of Kovacaine Mist (Kovacaine Mist High Dose)	ddtvakebse = upxrnovdvu kgvbxsxukz (ubgarlahuw, ylssdpiorx - hjfxsrqpcq) View more	-	30 Aug 2017
				200uL of Kovacaine Mist (Kovacaine Mist Mid Dose)	qpbsezaorh = bnqpgxikgj sbftospokd (kogpnmugbp, zdegryoack - iahbmqttmq) View more
NCT01479517 (CTgov)	Phase 2	Anesthesia	30	Kovacaine (Kovacaine Mist 0.1 mL x 4 Sprays)	jynxtnczdt = gsoivbplcs leakdliyzs (guhwowdiyo, mugofkilca - wdchlbrqgy) View more	-	29 Dec 2016
				Kovacaine (Kovacaine Mist 0.2 mL x 2 Sprays)	jynxtnczdt = zuhxpypwbu leakdliyzs (guhwowdiyo, ytkuorozeg - vgdukeptvm) View more