St. Renatus, LLC Announces FDA Approval of KOVANAZE™ (tetracaine HCl and oxymetazoline HCl) Nasal Spray for Use in Dentistry

News provided by

Jul 12, 2016, 01:15 ET

FORT COLLINS, Colo., July 12, 2016 /PRNewswire/ -- St. Renatus, LLC, a privately held company based in Fort Collins, Colorado, is pleased to announce it received U.S. Food and Drug Administration (FDA) approval on June 29, 2016 for its first product, a new dental anesthetic, KOVANAZE™ (tetracaine HCl and oxymetazoline HCl) Nasal Spray. This is the first product that allows for dental anesthesia to be administered through a nasal spray without using a needle.

"For more than 100 years, the dental industry has delivered dental anesthesia using a needle injection. Now, through the efforts of a dedicated team, we have developed a revolutionary needle-free method for delivering pulpal anesthesia," said Steve Merrick, St. Renatus' CEO.

Kovanaze is intended for use in dentistry as a topical anesthetic, delivered in the nasal cavity to achieve pulpal (tooth nerve) anesthesia for the restorative treatment of teeth. Like traditional dental injections, this product delivers a local dental anesthetic but without the needle.

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.

About St. Renatus
St. Renatus, LLC was founded to develop a revolutionary innovation—the world's first-known dental anesthetic administered through the nasal cavity, designed for use in procedures involving most of the upper teeth, with a goal of gaining FDA approval to commercialize and distribute. The company's name comes from the patron saint of anesthesia and has Latin roots meaning new beginning.

Learn more about St. Renatus by visiting www.st-renatus.com . Customer support line for Kovanaze: 1-800-770-9400.

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use KOVANAZE™ NASAL SPRAY safely and effectively. See the full package insert for prescribing information for KOVANAZE NASAL SPRAY.

KOVANAZE (tetracaine HCl and oxymetazoline HCl) Nasal Spray Initial
U.S. Approval: 2016

---------------------------INDICATIONS AND USAGE---------------------------

KOVANAZE contains tetracaine HCl, an ester local anesthetic, and oxymetazoline HCl, a vasoconstrictor. 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.

-----------------------DOSAGE AND ADMINISTRATION-----------------------

KOVANAZE is for intranasal use only. Administer KOVANAZE ipsilateral (on the same side) to the maxillary tooth on which the dental procedure will be performed.

Age Group	Dose
Adults (≥ 18 years old)	2 sprays (0.2 mL per spray), 4 to 5 minutes apart
Adults (≥ 18 years old)	1 additional spray (0.2 mL) if adequate anesthesia has not been achieved 10 minutes after the second spray
Children who weigh 40 kg or more	2 sprays (0.2 mL per spray), 4 to 5 minutes apart

---------------------DOSAGE FORMS AND STRENGTHS----------------------

Nasal spray in pre-filled, single-use sprayer: 6 mg tetracaine HCl and 0.1 mg oxymetazoline HCl (equivalent to 5.27 mg tetracaine and 0.088 mg oxymetazoline) in each 0.2 mL spray.

------------------------------CONTRAINDICATIONS------------------------------

Known hypersensitivity to tetracaine, benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or any other component of the product.

-----------------------WARNINGS AND PRECAUTIONS------------------------

Hypertension and Thyroid Disease: Shown to increase blood pressure in some clinical trial patients. Monitor blood pressure. Use in patients with inadequately controlled hypertension or active thyroid disease is not advised (5.1).

Epistaxis: Use is not recommended in patients with a history of frequent nose bleeds (≥5 per month). If a decision to use is made, monitor these patients carefully.

Dysphagia: Carefully monitor patients for dysphagia.

Methemoglobinemia: May cause methemoglobinemia, particularly when used with methemoglobin-inducing agents. Use in patients with history of congenital or idiopathic methemoglobinemia not advised. If central cyanosis unresponsive to oxygen therapy occurs, suspect methemoglobinemia, confirm diagnosis with co-oximetry, and treat with a standard clinical regimen.

Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.

------------------------------ADVERSE REACTIONS------------------------------

The most common adverse reactions occurring in >10% of patients include rhinorrhea, nasal congestion, lacrimation increased, nasal discomfort, and oropharyngeal pain.

Transient, asymptomatic elevations in systolic blood pressure (≥ 25 mm Hg from baseline) and diastolic blood pressures (≥ 15 mm Hg from baseline) have been reported.

To report SUSPECTED ADVERSE REACTIONS, contact St. Renatus, LLC at 1-800-865-4925 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

------------------------------DRUG INTERACTIONS------------------------------

Monoamine oxidase inhibitors (MAOIs): Concomitant use of MAOIs, nonselective beta adrenergic antagonists, or tricyclic antidepressants may cause hypertension and is not recommended.

Oxymetazoline-containing products: Discontinue use 24 hours prior to KOVANAZE administration. Intranasal products: Avoid concomitant use.

SOURCE St. Renatus, LLC