About OraVerse™

It’s about time

Bring your patients back.

Is your treatment regimen ready for a simple yet dramatic enhancement?

So often, patients look to you for the restoration of lost function or esthetics, and ultimately a rediscovery of comfort and confidence. Now OraVerse redefines that promise after routine care.

When local anesthetics with vasoconstrictors are used, they produce prolonged loss of oral function and sensation. On average, it takes 3-5 hours to recover from soft tissue anesthesia. With OraVerse, you have the opportunity to accelerate this process and return patients to normal in about half that time.1 And nationwide clinical studies prove the safety and efficacy of this novel formulation for phentolamine mesylate, a vasodilator used in medical applications for the last 50 years. Download our OraVerse brochure for Dental Professionals.

Product Characteristics
Clinical Pharmacology
Research Summaries

Product Characteristics

OraVerse (phentolamine mesylate) Injection is a clear, colorless, sterile, non pyrogenic, isotonic, preservative free solution. Each 1.8 mL cartridge contains 0.4 mg phentolamine mesylate.

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Clinical Pharmacology

Mechanism of Action

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, produces an alpha-adrenergic block of relatively short duration resulting in vasodilatation when applied to vascular smooth muscle. In an animal model, OraVerse increased local blood flow in submucosal tissue of the dog when given after an intraoral injection of lidocaine 2% with 1:100,000 epinephrine.

Pharmacokinetics

Following OraVerse administration, phentolamine is 100% available from the submucosal injection site and peak concentrations are achieved 10-20 minutes after injection. Phentolamine systemic exposure increased linearly after 0.8 mg compared to 0.4 mg OraVerse intraoral submucosal injection. The terminal elimination half-life of phentolamine in the blood was approximately 2-3 hours. The lidocaine concentration increased after OraVerse injection, which suggests that OraVerse promotes clearance of lidocaine from oral tissue into systemic circulation.2

Pediatrics

Following OraVerse administration, the phentolamine Cmax was higher (approximately 3.5-fold) in children who weighed between 15 and 30 kg (33 and 66 lbs) than in children who weighed more than 30 kg. However, phentolamine AUC was similar between the two groups. It is recommended that in children weighing 15-30 kg, the maximum dose of OraVerse should be limited to 1/2 cartridge (0.2 mg). The pharmacokinetics of OraVerse in adults and in children who weighed more than 30 kg (66 lbs) are similar after intraoral submucosal injection. OraVerse has not been studied in children under 3 years of age or weighing less than 15 kg (33 lbs). The pharmacokinetics of OraVerse after administration of more than 1 cartridge (0.4mg) has not been studied in children.

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The average duration of soft tissue anesthesia following the administration of a local anesthetic is 3-5 hours. With OraVerse, patients can return to normal sensation and function in about half that time.1


OraVerse Research Summaries

To find out more about our clinical trials download our research summaries below.

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1 Median time to recovery was reduced by 85 minutes (55%) for lower lip and by 83 minutes (62%) for upper lip compared to control. Median time to recovery of normal tongue sensation was reduced by 65 minutes (52%) compared to control. Median time to recovery of normal function was reduced by 60 minutes (50%) in the mandible and by 45 minutes (43%) in the maxilla.

2 Moore PA, Hersh EV, Papas AS, Goodson JM, Yagiela JA, Rutherford B, Rogy S, Navalta L. Pharmacokinetics of lidocaine with epinephrine following local anesthesia reversal with phentolamine mesylate. Anesth Prog 2008; 55(2):40-48