Safety and Pharmacokinetics of Kovacaine Nasal Spray (24 Hour Blood Collection)

The purpose of this study is to determine the pharmacokinetics and safety of tetracaine,
para- butylaminobenzoic acid (PBBA), and oxymetazoline after intranasal administration of
the highest Phase 3 dose of Kovacaine Mist (Tetracaine Hydrochloride with Oxymetazoline
Hydrochloride) to healthy volunteers.

This is an open-label, single-treatment, single-dose study in healthy volunteers in which
all subjects will receive the highest Phase 3 dose of Kovacaine Mist on one occasion. No
randomization is necessary for this single treatment, single dose study. A single study
center will participate.

Each subject will receive a single dose of Kovacaine Mist (3% tetracaine HCl with 0.05%
oxymetazoline HCl) consisting of 3 sprays (each 0.2 mL) in one nostril not taking longer
than 8 minutes, for a total 0.6 mL dose containing 18 mg tetracaine HCl and 0.3 mg
oxymetazoline HCl.

The total dosing period will be 8 minutes. Subjects will be required to fast 10 hours prior
to dosing and for four (4) hours after dosing. Water will be allowed ad lib during the study
except for one (1) hour prior through one (1) hour after dose administration. Subjects will
be admitted to the study unit no later than 2100 hours of the evening prior to drug
administration and will remain in the unit until the 24 hour blood sample is collected and
discharge procedures are completed.

Inclusion Criteria:

- Male or non-pregnant, non-breast-feeding female subjects between the ages of 18 and
75 years (inclusive).

- Can understand and sign the informed consent document, can communicate with the
investigator, and can understand and comply with the requirements of the protocol.

- Body mass index between 18 and 35 BMI.

- Sufficiently healthy as determined by the investigator to receive the test
medications and undergo the scheduled study procedure.

- Can breathe through both nostrils.

- Screening BP ≤ 140/90 mm Hg.

Exclusion Criteria:

- History of clinically significant respiratory, gastrointestinal, renal, hepatic,
neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric,
or cardiovascular disease, including cardiac arrhythmia, narrow angle glaucoma and
benign prostatic hypertrophy (in men), uncontrolled thyroid disease (including
Hashimoto's Thyroiditis and lymphocytic thyroiditis), uncontrolled diabetes mellitus
or any other condition which, in the opinion of the Principal Investigator, would
jeopardize the safety of the subject or impact the validity of the study results.

- Has clinically significant abnormal findings on the physical examination, medical
history, electrocardiogram (ECG), or clinical laboratory evaluation during screening.
This includes current upper respiratory infections.

- Currently experiencing seasonal or perennial allergic rhinitis, recurrent nose-bleeds
or asthma, or has a significant history of these conditions, in the opinion of the
Investigator.

- Current, including the last 30 days, sinusitis or other upper respiratory infections.

- Nasal polyps, significant nasal or sinus surgery or other abnormality that may
interfere with the dose administration.

- History of allergic or adverse responses to tetracaine, other ester local
anesthetics, PBBA, oxymetazoline and its preservatives, or para-aminobenzoic acid as
found in PABA containing sunscreens or any comparable or similar product.

- Donation of blood or plasma within 30 days of the first dose of Study Drug.

- Participation in a clinical trial within 30 days prior to the first dose of Study
Drug.

- Use of any new over-the-counter (OTC) medication, including topical anesthetic creams
or gels, vitamins, within seven days prior to the first dose of the Study Drug or
during the study unless approved by the Principal Investigator.

- Any prescription medication, whose dose is not stable at the time of screening, as
determined by the Principal Investigator.

- Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines,
cimetidine, carbamazepine, etc., within 30 days prior to the first dose of Study Drug
or during the study.

- Smoking or use of tobacco products within 6 months prior to the first dose of Study
Drug or during the study.

- Female trying to conceive, is pregnant, suspected of being pregnant, or is lactating.
(Females of child-bearing potential will be required to take a serum pregnancy test
at screening (up to 21 days prior to the start of the study, including the day of the
study), as well as a urine pregnancy test at check-in to rule out pregnancy.)

- Positive serum pregnancy test at screening or urine pregnancy test at check-in for
all women of childbearing potential.

- Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C,
or a positive urine screen for alcohol, drugs of abuse, or cotinine.

- Have a history of pseudocholinesterase deficiency or previous prolonged paralysis
with succinylcholine or difficulty waking up from general anesthesia.

- Have a history of alcoholism and/or drug abuse.

- Have taken a monoamine oxidase inhibitor or vasopressor drug within the past 3 weeks.