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St. Renatus, LLC Announces the Product Launch of Kovanaze™ Nasal Spray at the 2016 American Dental Association (ADA) Meeting

October 21, 2016 – DENVER, CO – St. Renatus LLC announced today that Kovanaze™ (tetracaine HCl and oxymetazoline HCl) Nasal Spray, the first FDA-approved, needle-free, regional dental anesthesia for the maxillary arch, is available for pre-order. The Kovanaze product launch coincides with the American Dental Association’s annual meeting in Denver, October 20-24.

Approved by the U.S. Food and Drug Administration (FDA) on June 29, 2016, Kovanaze is indicated for regional anesthesia when performing a restorative procedure on teeth 4-13 and A-J in adults and children weighing more than 40 kg.

In Phase 3 clinical trials, use of Kovanaze in the anterior maxillary region during restorative procedures resulted in 96 percent efficacy in teeth 5-12 and 63 percent efficacy in teeth 4 and 13. Additionally, patients may not experience the same sensation of numbness or tingling of the lips and cheeks associated with injectable dental anesthetics.

“It is a significant moment in dentistry as a new delivery method for pain management is now available,” said Steve Merrick, St. Renatus, Chief Executive Officer. “For decades, needles have been the mainstay for delivering dental anesthesia; now dentists have the option to offer patients a regional anesthesia via a nasal spray for restorative procedures in the smile zone.”

To learn more or to place an order, please visit Kovanaze.com, call the Kovanaze Support Line at 1- 800-770-9400, or contact your local dental dealer.

IMPORTANT SAFETY INFORMATION: Use in patients with uncontrolled hypertension or inadequately controlled active thyroid disease of any type is not advised. Tetracaine may cause methemoglobinemia, particularly in conjunction with methemoglobin-inducing agents. Use of KOVANAZE in patients with a history of congenital or idiopathic methemoglobinemia is not advised. Methemoglobinemia should be considered if central cyanosis unresponsive to oxygen therapy occurs, especially if methemoglobinemia-inducing agents have been used. Confirm diagnosis by measuring methemoglobin level with co-oximetry. Treat clinically significant symptoms of methemoglobinemia with a standard clinical regimen. Allergic or anaphylactic reactions can occur. If an allergic reaction occurs, seek emergency help immediately. KOVANAZE is contraindicated in patients with a history of allergy to tetracaine, benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or any other component of the product. Some clinical trial patients experienced an increase in blood pressure so blood pressure should be monitored. In addition, patients should be carefully monitored for dysphagia. KOVANAZE is not recommended for use in patients with a history of frequent nose bleeds. Concomitant use of monamine oxidase inhibitors, nonselective beta adrenergic antagonist, or tricyclic antidepressants may cause hypertension and is not recommended. Discontinue use of oxymetazoline-containing products 24 hours prior to KOVANAZE administration. Avoid concomitant use of intranasal products. The most common adverse reactions to KOVANAZE occurring in >10% of patients include a runny nose, nasal congestion, nasal discomfort, sore throat, and watery eyes.

About St. Renatus, LLC

St. Renatus, LLC, named after the patron saint of anesthesia, is a privately held company based in Fort Collins, Colorado. Seeking to enhance patient comfort through innovation, this dedicated team of professionals began drug development efforts more than 10 years ago. Kovanaze™ (tetracaine HCl and oxymetazoline HCl) Nasal Spray, the first FDA-approved, needle- free, regional dental anesthetic, represents a revolutionary new product created for patients and practitioners alike.

Copyright © 2016 St. Renatus. All Rights Reserved.

Important Safety Information

IMPORTANT SAFETY INFORMATION: KOVANAZE is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more. Use in patients with uncontrolled hypertension or inadequately controlled active thyroid disease of any type is not advised. Tetracaine may cause methemoglobinemia, particularly in conjunction with methemoglobin-inducing agents. Use of KOVANAZE in patients with a history of congenital or idiopathic methemoglobinemia is not advised. Methemoglobinemia should be considered if central cyanosis unresponsive to oxygen therapy occurs, especially if methemoglobinemia-inducing agents have been used. Confirm diagnosis by measuring methemoglobin level with co-oximetry. Treat clinically significant symptoms of methemoglobinemia with a standard clinical regimen. Allergic or anaphylactic reactions can occur. If an allergic reaction occurs, seek emergency help immediately. KOVANAZE is contraindicated in patients with a history of allergy to tetracaine, benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or any other component of the product. Some clinical trial patients experienced an increase in blood pressure so blood pressure should be monitored. In addition, patients should be carefully monitored for dysphagia. KOVANAZE is not recommended for use in patients with a history of frequent nose bleeds. Concomitant use of monamine oxidase inhibitors, nonselective beta adrenergic antagonist, or tricyclic antidepressants may cause hypertension and is not recommended. Discontinue use of oxymetazoline-containing products 24 hours prior to KOVANAZE administration. Avoid concomitant use of intranasal products. The most common adverse reactions to KOVANAZE occurring in >10% of patients include a runny nose, nasal congestion, nasal discomfort, sore throat, and watery eyes.

Click here for full Prescribing Information: Package Insert

IMPORTANT SAFETY INFORMATION: Use in patients with uncontrolled hypertension or inadequately controlled active thyroid disease of any type is not advised. Tetracaine may cause methemoglobinemia, particularly in conjunction with methemoglobin-inducing agents. Use of KOVANAZE in patients with a history of congenital or idiopathic methemoglobinemia is not advised. Methemoglobinemia should be considered if central cyanosis unresponsive to oxygen therapy occurs, especially if methemoglobinemia-inducing agents have been used. Confirm diagnosis by measuring methemoglobin level with co-oximetry. Treat clinically significant symptoms of methemoglobinemia with a standard clinical regimen. Allergic or anaphylactic reactions can occur. If an allergic reaction occurs, seek emergency help immediately. KOVANAZE is contraindicated in patients with a history of allergy to tetracaine, benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or any other component of the product. Some clinical trial patients experienced an increase in blood pressure so blood pressure should be monitored. In addition, patients should be carefully monitored for dysphagia. KOVANAZE is not recommended for use in patients with a history of frequent nose bleeds. Concomitant use of monamine oxidase inhibitors, nonselective beta adrenergic antagonist, or tricyclic antidepressants may cause hypertension and is not recommended. Discontinue use of oxymetazoline-containing products 24 hours prior to KOVANAZE administration. Avoid concomitant use of intranasal products. The most common adverse reactions to KOVANAZE occurring in >10% of patients include a runny nose, nasal congestion, nasal discomfort, sore throat, and watery eyes.

Click here for full Prescribing Information: Package Insert