CLINICAL TRIALS PROFILE FOR ORAVERSE

All Clinical Trials for Oraverse

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01474382 ↗	Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients	Completed	Novocol Pharmaceutical of Canada, Inc.	Phase 4	2012-02-01	The purpose of this study is to determine whether OraVerse is safe and effective for the reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.
NCT02861378 ↗	Reversing the Effects of 2% Lidocaine	Completed	Dalhousie University	N/A	2015-10-01	Dental procedures often require the use of local anesthesia. The effects of the anesthesia usually linger for some time after the dental procedure is completed which can lead to discomfort and occasionally injury from lip/tongue biting. Clinical trials have shown phentolamine mesylate (OraVerse) to be effective at reducing the amount of time to reversal of local anesthesia compared to sham injections. However, no trials have been conducted comparing phentolamine mesylate to a true control injection. Such trials are needed in order to definitively show that it is the phentolamine mesylate itself that is causing the reduction in anesthesia rather than a dilution effect. The objective of the proposed research is to conduct a pilot-scale randomized clinical trial evaluating the difference in time required to the return of normal soft-tissue sensation and function in participants who had received an inferior alveolar nerve block (using 2% Lidocaine 1:100,000 epinephrine), followed by an injection with either 1) OraVerse (phentolamine mesylate) or 2) sterile physiological water (control). The study population will comprise dentistry and dental hygiene students of the second year classes at Dalhousie University, Halifax, NS, Canada. This study population has been chosen because these students usually practice dental anesthesia on each other as a part of a course on local anesthesia. This proposed pilot scale study will be a double-blind controlled trial using parallel groups. As part of their usual anaesthesia course, the dental and dental hygiene students will be practicing their inferior alveolar nerve injections on one another using 2% Lidocaine 1:100,000 epinephrine. Students who decide to participate in the study will be randomly assigned to one of two groups: Group 1 will receive an injection of OraVerse (treatment group), while Group 2 will receive an injection of sterile physiological water (control group). The time required to the return of soft-tissue sensation and function will be assessed using a questionnaire.
NCT02995291 ↗	Reversing the Effects of 0.5% Bupivacaine	Completed	Dalhousie University	Phase 4	2017-02-10	Clinical trials have shown phentolamine mesylate (PM), brand name OraVerse, to be effective at reducing the amount of time to reversal of local anesthesia with different dental anesthetics. However, to date no study investigated the efficacy of phentolamine mesylate to reverse anesthesia induced with the use of Bupivacaine. The objective of the proposed research is to conduct a pilot-scale randomized clinical trial evaluating the difference in time required for the return of normal soft-tissue sensation and function in participants who have received 0.5% Bupivacaine HCl, 1:200,000 epinephrine, followed by an injection with either 1) OraVerse (phentolamine mesylate) or 2) sterile physiological water (control).

Clinical Trial Conditions for Oraverse

Condition Name

Condition Name for Oraverse
Intervention	Trials
Anesthesia, Local	3
Reversal of Local Anesthesia in Children	1
Soft Tissue Anaesthesia	1

Condition MeSH

Condition MeSH for Oraverse
Intervention	Trials
Soft Tissue Injuries	1

Clinical Trial Locations for Oraverse

Trials by Country

Trials by Country for Oraverse
Location	Trials
United States	6
Canada	2
Egypt	1

Trials by US State

Trials by US State for Oraverse
Location	Trials
Washington	1
Utah	1
Pennsylvania	1
Ohio	1
Indiana	1

Clinical Trial Progress for Oraverse

Clinical Trial Phase

Clinical Trial Phase for Oraverse
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
N/A	2

Clinical Trial Status

Clinical Trial Status for Oraverse
Clinical Trial Phase	Trials
Completed	4
Recruiting	1
Not yet recruiting	1

Clinical Trial Sponsors for Oraverse

Sponsor Name

Sponsor Name for Oraverse
Sponsor	Trials
Dalhousie University	2
Novocol Pharmaceutical of Canada, Inc.	1
León Formación	1

Sponsor Type

Sponsor Type for Oraverse
Sponsor	Trials
Other	5
Industry	1

OraVerse: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to OraVerse

OraVerse, developed by Novalar Pharmaceuticals and now owned by Septodont, is the first and only FDA-approved local anesthesia reversal agent. It is designed to accelerate the return to normal sensation and function after routine dental procedures involving local anesthetics with vasoconstrictors.

Clinical Trials and Efficacy

Phase 3 Studies in Adults and Adolescents

The approval of OraVerse is based on data from two Phase 3 clinical studies conducted in 18 centers across the United States. These studies involved 484 dental patients and demonstrated that OraVerse significantly reduced the median time to recovery of normal sensation in both the lower and upper lips. Specifically, OraVerse reduced the recovery time by 85 minutes for the lower lip and 83 minutes for the upper lip compared to the control group[1][2].

Phase 2 Pediatric Study

A multi-center, randomized, double-blinded, controlled Phase 2 study evaluated the safety and efficacy of OraVerse in children aged 6-11. This study enrolled 152 patients and showed that OraVerse reduced the median time to normal sensation by 75 minutes, representing a 56% acceleration in recovery time[1].

Safety Profile

Clinical trials have shown that OraVerse is well-tolerated with no serious adverse events reported. The most common adverse reaction was transient injection site pain, which was mild to moderate in severity. There were no known drug interactions or contraindications identified[4].

Market Analysis

Acquisition and Distribution

Septodont acquired the OraVerse product line from Novalar Pharmaceuticals, taking over all sales, marketing, and regulatory responsibilities. This acquisition aligns well with Septodont's existing portfolio, particularly its compatibility with Septocaine, another leading dental anesthetic[2].

Market Positioning

OraVerse is unique in its category as the first FDA-approved local anesthesia reversal agent. Its compatibility with common dental anesthetics and ease of administration (using the same injection site and technique as local anesthetics) make it an attractive option for dentists. The product has been distributed in various markets, including Europe and Israel, through partnerships with other companies[2].

Market Projections

Growing Demand for Dental Solutions

The dental market is expected to grow, driven by increasing demand for efficient and safe dental procedures. OraVerse, with its proven efficacy in reducing recovery times, is well-positioned to capitalize on this trend.

Integration with Existing Products

Septodont's established dealer relationships, manufacturing expertise, and complementary product lines (such as Septocaine) are expected to enhance the market penetration of OraVerse. The company's resources and marketing capabilities will likely drive the product's growth in both North American and international markets[2].

Industry Trends and Impact

Advancements in Clinical Trials

The broader clinical trials market, including omics-based trials, is expected to grow significantly, driven by advancements in technology and the increasing need for personalized medicine. While OraVerse's clinical trials were not omics-based, the trend towards more targeted and efficient clinical trials could influence future research and development in dental anesthesia reversal agents[3].

Regulatory Environment

The supportive regulatory framework, particularly in North America, is conducive to the development and approval of innovative dental products like OraVerse. Regulatory agencies' recognition of the importance of such products in improving patient outcomes will continue to support market growth[3].

Key Takeaways

• Efficacy: OraVerse significantly reduces the recovery time from local anesthesia, allowing patients to regain normal sensation and function faster.
• Safety: Clinical trials have shown OraVerse to be well-tolerated with minimal adverse events.
• Market Position: As the first FDA-approved local anesthesia reversal agent, OraVerse has a unique market position and is expected to benefit from Septodont's resources and distribution networks.
• Growth Potential: The product is poised for growth due to increasing demand for efficient dental solutions and supportive regulatory environments.

FAQs

What is OraVerse used for?

OraVerse is used to reverse the effects of local anesthesia after dental procedures, allowing patients to regain normal sensation and function faster.

How does OraVerse work?

OraVerse works by reversing the effects of local anesthetics that contain vasoconstrictors, accelerating the return to normal sensation and function.

Is OraVerse safe for children?

Yes, OraVerse has been tested and approved for use in children aged 6 and older, weighing at least 33 pounds, and has shown to be safe and effective in pediatric clinical trials[1][2].

What are the common side effects of OraVerse?

The most common adverse reaction reported is transient injection site pain, which is typically mild to moderate[1][4].

Who currently distributes OraVerse?

Septodont, following its acquisition from Novalar Pharmaceuticals, is responsible for the sales, marketing, and regulatory responsibilities of OraVerse[2].

Sources

1. Drugs.com - OraVerse: Uses, Dosage, Side Effects
2. DrBicuspid.com - Septodont acquires OraVerse from Novalar
3. Biospace.com - Omics-based Clinical Trials Market Size to Hit USD 70.92 Billion by 2034
4. OraVerse.com - Safety & Efficacy - OraVerse

Last updated: 2025-01-03