Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

• Soft Tissue anesthesia [ Time Frame: Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes ] [ Designated as safety issue: No ]
  Assessment of pain using a Rotadent sensor probe, applying up to 20 grams/cm2 at the tissue site.
• Pulse and Pulse oximetry [ Time Frame: Baseline, 15, 20, 30, 40, 50, 60, 120 minutes ] [ Designated as safety issue: Yes ]
• Blood Pressure [ Time Frame: Baseline, 15, 20, 30, 40 50, 60, 120 minutes ] [ Designated as safety issue: Yes ]

The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental procedures.

The primary objective of this single-center, randomized, double-blind, active-controlled, parallel-group study was to determine if Kovacaine Mist provided anesthesia of the maxillary teeth sufficient for the performance of dental procedures. Secondary objectives included a determination of whether Kovacaine Mist provided anesthesia of the soft tissue and to evaluate the safety and tolerability of Kovacaine Mist and sham injection as compared to sham nasal spray and 2% lidocaine hydrochloride with 1:100,000 epinephrine submucosal injection and as determined by changes in vital signs and reports of side effects and adverse events.

• Drug: 3% tetracaine hydrochloride plus 0.05% oxymetazoline hydrochloride
  Each subject received both an injection (lidocaine or sham) and 3 doses of nasal spray (Kovacaine Nasal Spray or isotonic saline sham; each dose was 2 sprays with a single spray in each nostril and a 4-minute interval between subsequent doses). The total dose of tetracaine HCl/oxymetazoline HCl was 18 mg/0.3 mg.
  Other Name: Kovacaine Nasal Spray
• Drug: Lidocaine Injection
  Each subject received both an injection (lidocaine or sham) and 3 doses of nasal spray (Kovacaine Nasal Spray or isotonic saline sham; each dose was 2 sprays with a single spray in each nostril and a 4-minute interval between subsequent doses).

• Experimental: Kovacaine Nasal Spray
  Intervention: Drug: 3% tetracaine hydrochloride plus 0.05% oxymetazoline hydrochloride
• Active Comparator: Lidocaine Injection
  Intervention: Drug: Lidocaine Injection

Inclusion Criteria:

• Male or female between 18 and 65 years of age
• Sufficiently healthy as determined by the investigator to receive the test and control medications and undergo the scheduled dental procedure
• Required an operative restorative procedure on a single maxillary tooth, other than a maxillary second or third molar, with treatment time not expected to exceed 60 minutes
• Could breathe through both nostrils
• Had normal lip, nose, eyelid, and cheek sensations
• Could understand and sign the informed consent document
• Could communicate with the investigator
• Could understand and comply with the requirements of the protocol

Exclusion Criteria:

• Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, cardiovascular, psychiatric, musculoskeletal, neurologic, genitourinary, infective, inflammatory, immunological, dermatological, or connective tissue disease or disorder or a clinically relevant history or presence of angle-closure glaucoma
• Clinically relevant sinus/nasal surgical history
• Baseline VAX > 36 (or greater than weak) at the treatment site
• Had not had dental work requiring a local anesthetic within the last 24 hours or had taken pain medications within the last 48 hours
• Required prophylactic antibiotics for subacute bacterial endocarditis (infectious endocarditis)
• Allergic to or intolerant of tetracaine, benzocaine, other ester local anesthetics, or PABA (as found in PABA-containing sunscreens)
• Allergic to or intolerant of oxymetazoline, epinephrine, or preservatives in their solutions
• Had a current condition, such as nasal congestion or sinus infection, that may have influenced responses to study medications
• History of alcoholism and/or drug abuse
• Had taken a monamine oxidase inhibitor within the past 3 weeks
• Were nursing, pregnant, suspected of being pregnant, or trying to become pregnant (females were required to take a urine pregnancy test to rule out pregnancy)
• Had used any investigational drug and/or participated in any clinical trial within 30 days of baseline