FAQs for Dental Professionals
What is OraVerse™?What is the clinical indication for OraVerse?
How does OraVerse work?
Is OraVerse easy to administer?
What types of studies were conducted with OraVerse?
How safe is OraVerse?
How effective is OraVerse in reversing soft tissue anesthesia?
Which anesthetics was OraVerse tested with?
What are the contraindications for OraVerse?
What were the adverse events with OraVerse?
Should I be concerned with OraVerse toxicity or drug interactions?
How is OraVerse supplied and how is it dosed?
When should I administer OraVerse?
Will my patients experience more pain if the anesthesia wears off faster?
Will a second injection cause my patient to experience more pain?
What effect does OraVerse have on the cardiovascular system?
Can I use OraVerse as an antidote for an overdose of anesthetic?
Is there any increased risk for injection site complications?
What is the half-life of OraVerse?
Will OraVerse be reimbursed by dental insurance plans?
Q. What is OraVerse?
A. OraVerse (phentolamine mesylate) Injection is a local dental anesthesia reversal agent that accelerates the return to normal sensation and function for patients who want to avoid the unwanted and unnecessary lingering soft tissue anesthesia after routine dental procedures.
Q. What is the clinical indication for OraVerse?
A. OraVerse is indicated for the reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor. OraVerse is not recommended for use in children less than 6 years of age or weighing less than 15 kg (33 lbs).
Q. How does OraVerse work?
A. The mechanism by which OraVerse accelerates reversal of soft-tissue anesthesia and the associated functional deficits is not fully understood. Phentolamine mesylate, the active ingredient in OraVerse, is a vasodilator that has been used in other medical indications since 1952.
Q. Is OraVerse easy to administer?
A. OraVerse comes in a standard dental cartridge. It is easily administered with a standard syringe utilizing the same injection site and an identical administration technique as that used for local anesthetic.
Q. What types of studies were conducted with OraVerse?
A. Multicenter, double-blinded, randomized, controlled clinical trials were conducted involving dental patients aged 4 through 92. Maxillary and mandibular trials were conducted in adolescent and adult dental patients who had restorative or periodontal maintenance procedures and who had received one of four leading anesthetics that contained a vasoconstrictor. In a pediatric trial, patients aged 4-11 were studied. A subset of 115 patients, aged 6-11, were included in the efficacy evaluation. OraVerse is not recommended for use in children less than 6 years of age or weighing less than 15 kg (33 lbs).
Q. How safe is OraVerse?
A. OraVerse is the first and only FDA approved product to rapidly reverse the effects of your patients’ local dental anesthetic. It is scientifically proven to be safe and effective based on comprehensive clinical trials involving children, adolescents and adults aged 4 through 92.1
In multicenter, double-blinded, randomized controlled trials enrolling patients 4 to 92 years of age, OraVerse had no effect on adverse events, pain or post-treatment analgesic use, vital signs or oral mucosa.
back to topQ. How effective is OraVerse in reversing soft tissue anesthesia?
A. When local anesthetics with vasoconstrictors are used, they produce prolonged loss of oral sensation and function. On average, it takes 3-5 hours to recover from soft tissue anesthesia. With OraVerse, patients can return to normal sensation and function in about half that time.
In adult and adolescent clinical trials, OraVerse reduced the median time to recovery of normal sensation in the lower lip by 85 minutes (55%), and in the upper lip by 83 minutes (62%) compared to control. In both maxillary and mandibular procedures, the median time to observed recovery of normal function was significantly reduced for patients receiving OraVerse (43% and 50% reduction, respectively).
In a pediatric clinical trial with 152 patients, aged 4-11, the time to recovery of normal lip sensation was accelerated by 53 minutes (47%) in the maxilla and 120 minutes (67%) in the mandible compared to control.
back to topQ. Which anesthetics was OraVerse tested with?
A. In clinical trials, OraVerse was used with four leading anesthetics containing a vasoconstrictor: lidocaine 2% with epinephrine 1:100,000, articaine 4% with epinephrine 1:100,000, prilocaine 4% with epinephrine 1:200,000, and mepivacaine 2% with levonordefrin 1:20,000.
Q. What are the contraindications for OraVerse?
A. There are no contraindications for OraVerse. In nationwide comprehensive clinical trials OraVerse was tested in subjects physically qualified for routine dental restorative and periodontal maintenance procedures involving a local anesthetic with vasoconstrictor.
The most frequent co-morbidity in adults was hypertension and in children (<12 y/o) was asthma. No problems were observed in these sub-sets of subjects. Pregnant subjects were excluded from study.
OraVerse is not indicated for use in individuals less than 6 years of age or weighing less than 15 kg (33 lbs).
back to topQ. What were the adverse events with OraVerse?
A. In multi-center, controlled, randomized double-blinded clinical trials there were no serious adverse events and no discontinuation due to adverse events. The majority of adverse events were mild and resolved within 48 hours. The frequency of adverse events was similar among OraVerse and control groups. In addition OraVerse had no effect on pain, post-treatment analgesic use, vital signs or oral mucosa compared to control.
Q. Should I be concerned with OraVerse toxicity or drug interactions?
A. There are no known drug interactions with OraVerse, and across all studies there was no evidence of toxicity.1
Q. How is OraVerse supplied and how is it dosed?
A. OraVerse is supplied in boxes of 10 and 50 cartridges. The 50 cartridge box contains 5 trays with 10 cartridges each. Each cartridge contains 0.4mg of phentolamine mesylate in 1.7ml of solution.
The dosing for OraVerse is in a 1:1 ratio to local anesthetic.
| Amount of Local Anesthetic Administered | Dose of OraVerse |
| 1/2 Cartridge | 1/2 Cartridge (0.2 mg) |
| 1 Cartridge | 1 Cartridge (0.4 mg) |
| 2 Cartridges | 2 Cartridges (0.8 mg) |
OraVerse is administered using the same location(s) and same technique(s) (infiltration or block injection) used for the administration of local anesthetic.
In pediatric patients weighing 15-30 kg (33-66 lbs), the maximum dose of OraVerse recommended is 1/2 cartridge (0.2 mg).
back to topQ. When should I administer OraVerse?
A. OraVerse should be given at the end of the procedure, when there is no longer any need for pulpal anesthesia.
Q. Will my patients experience more pain if the anesthesia wears off faster?
A. In the comprehensive clinical trials OraVerse had no apparent effect on pain and post-treatment analgesic use. In these trials, patients underwent routine restorative and periodontal maintenance procedures (e.g., crown preparation, cavity preparation, scaling and root planning) which are not typically associated with significant post-procedural pain.
Q. Will a second injection cause my patient to experience more pain?
A. The injection for OraVerse is typically given while the soft tissue is still anesthetized. In clinical trials, there was only a 1% increase in injection site pain reported as an adverse event for those receiving OraVerse compared to those in the control group (5% vs. 4% respectively).
Q. What effect does OraVerse have on the cardiovascular system?
A. There is no evidence of OraVerse having any effects on vital signs (blood pressure, pulse, respiration and temperature) in clinical trials as compared to control.
Q. Can I use OraVerse as an antidote for an overdose of anesthetic?
A. No. OraVerse is indicated for accelerating the recovery of soft tissue sensation and function following the administration of a local dental anesthetic with a vasoconstrictor. In cases of overdose customary medical emergency procedures should be promptly implemented.
Q. Is there any increased risk for injection site complications?
A. The clinical trials did not demonstrate an increased risk for injection site complications.
Q. What is the half-life of OraVerse?
A. Clinical trials were conducted with children and adults that assessed the pharmacokinetics of phentolamine and its effect on lidocaine. In these studies, the half-life of OraVerse was 2-3 hours.
Q. Will OraVerse be reimbursed by dental insurance plans?
A. As OraVerse is a novel solution in dentistry, there is currently no Current Dental Terminology (CDT) code for the product or any reimbursement provided. Novalar is working with the appropriate industry professionals to secure a new CDT code to address a local anesthesia reversal agent and in the longer term to pursue insurance reimbursement for this new product category.
