Efficacy of ATNC05 in Reducing Back Pain Compared With Placebo

Back pain represents one of the most common and chronic physical ailments. In the United
States, acute back pain is the fifth most common reason for physician visits. In fact, nine
of ten adults experience back pain at some point in their life, and five out of ten working
adults report back pain every year.

While only a minority of individuals suffering from back pain resort to surgery, there are
only limited options for offering relief from chronic back pain. Heat therapy is one option
for short term relief, as well as alternative cold compression therapy proximate to the
location of pain. Alternative treatments such as massage therapy, acupressure and pressure
point massage have also been used. Some pharmaceuticals have shown usefulness in treating
back pain, including muscle relaxants, non-steroidal anti-inflammatory drugs, analgesics and
Opioid Agonists. However opioids are limited by side effects such as constipation and
sedation, as well as by dependence, tolerance and scheduling issue. NSAIDs avoid some of the
liabilities of opioids, yet they also have toxicities which can limit their usefulness.

Accordingly, there is a need in the art of treating back pain for an alternative
pharmaceutical composition that reduces the symptoms of back pain effectively and for longer
periods of time.

Inclusion Criteria:

The subject has chronic back pain for > 3 months in the lumbar, thoracic or cervical
regions.

The average pain intensity scale during the screening week is 4/10 - 8/10 (On an 11-point
Numeric Pain Intensity Scale with 0 = no pain and 10 = worst pain imaginable).

The subject has not taken Opioid medications 7 days prior to initiation of study drug.

The subject has a heart rate of 60bpm or above and/or systolic blood pressure 90 or above.

The subject is willing to refrain from using NSAIDS, Acetaminophen or muscle relaxants,
unless for rescue, for the duration of the study The subject is willing to refrain from
using Opioid medications and excessive alcohol for the duration of the study.

The subject is able to read, understand and follow the study instructions, including
completion of questionnaires at home.

The subject must sign an informed consent document indicating willingness to participate.

If the subject is a female, she must be post-menopausal, not currently pregnant or
nursing. A female of child bearing potential should be using a reliable contraception
method during the course of the study.

Exclusion Criteria:

The subject has a positive urine drug screen. The subject has a history of significant
neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or
metabolic disease.

The subject has any significant deviations from normal in physical examination,
electrocardiogram (ECG), Echocardiogram or clinical laboratory tests, as evaluated by the
investigator.

The subject has a history of an allergic reaction to the components of the study drug.

The subject has acute back or cervical pain. The subject has muscular back or cervical
pain. The subject has back or cervical pain other than chronic Radicular pain.