Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 in Lumbar Radiculopathy (Sciatica)

Inclusion Criteria:

1. Subjects must have a history of persistent pain secondary to unilateral
monoradiculopathy present for a minimum of 3 months prior to the study, with an
average pain intensity score of at least moderate over at least 50% of the day for the
7 days prior to the screening visit and over the 7 days prior to starting study
medication.

2. Males or females between 18 and 70 years of age, inclusive. Females who are pregnant
or breastfeeding will be excluded from the trial.

3. Subjects must be in generally good health, either using no medication or using a
stabilized medication regimen for chronic and well-controlled conditions such as
hypertension, allergies, stable endocrinopathies (e.g. hypothyroidism), etc. Subjects
with other active diseases will be reviewed on a case-by-case basis by the principal
investigator.

4. No concomitant therapy with any medication that is a known significant inhibitor or
inducer of CYP450 2D6 and CYP3A4, at the discretion of the PI.

5. Normal or clinically insignificant screening laboratory tests:

- Serum BUN, creatinine, bicarbonate, calcium, chloride, potassium, sodium, lactate
dehydrogenase, inorganic phosphate, total protein, glucose, albumin, and uric
acid. WBC, absolute neutrophil count, hemoglobin, hematocrit, and platelets. SGOT
(AST), SGPT (ALT), total bilirubin, alkaline phosphatase, TSH/T4, urinalysis, and
urine toxicology screen.

- Electrocardiogram (12-lead). Any significant laboratory abnormalities will be
reviewed by the principal investigator prior to inclusion of the subject in the
study.

6. Willingness to restrict analgesic therapy during inpatient admission days to the
allowed rescue analgesic agent permitted by the study (acetaminophen).

7. Subjects must have normal cognitive function and communicative ability in the English
language.

8. Subjects must be able to provide meaningful written informed consent.

9. Subjects must be able to maintain complete required questionnaires, and must be able
to fulfill all other conditions of the protocol.

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding, or plan to become pregnant while
participating in the study.

2. Subjects with a previous history of multiple or severe drug allergies, including
lidocaine.

3. Subjects with a history of or current chronic substance abuse, including alcohol.

4. Subjects who have participated in a study of an investigational drug or device within
30 days prior to screening for this study. Subjects must agree not to participate in
other investigational drug or device studies during the entire course of this study
(beginning with the screening visit).

5. Subjects with the following abnormal clinical evaluations:

- Impaired renal function defined as BUN > 45 or creatinine >2.0 and/or impaired
liver function defined as liver transaminases, alkaline phosphatase, or bilirubin
greater than 1.5 x upper limit of normal laboratory values.

- Prolonged PR (>200 ms) interval on electrocardiogram (12-lead). Subjects
presenting with the above laboratory abnormalities may be allowed on a
case-by-case basis at the discretion of the principal investigator.

6. Subjects who intend to donate blood or blood products while participating in this
study, and for 30 days following completion of the study.

7. Subjects with clinically significant renal, hepatic, or cardiac disease, with seizure
disorders, or with a clinical history of life-threatening arrhythmias (i.e. torsades
de pointes).

8. Subjects with a severe neuropsychiatric disorder requiring treatment.

9. Subjects with sensitivity to amide-type local anesthetics.