Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

Inclusion Criteria:

- Patients (male or female) 18 to 65 years of age, inclusive, at the time of dosing

- Have an established diagnosis (per McDonald Criteria) of Multiple Sclerosis (either
relapsing remitting or secondary progressive course), that manifests spasticity for
at least 6 months

- Spasticity due to MS as shown by a TNmAS score equal or greater than six (≥6) in
the most affected limb.

- EDSS equal or greater than 3.0

- If receiving disease-modifying medications, these must have been at a stable dose for
at least three (3) months prior to screening, and the subject must be willing to
maintain this treatment for the duration of the study

- Stable regimen for at least thirty (30) days prior to study entry for all medications
and non-pharmacological therapies that are intended to alleviate spasticity

- Absence of infections, peripheral vascular disease, painful contractures, advanced
arthritis, or other conditions that hinder evaluation of joint movement

- Have a creatinine clearance, as calculated by Glomerular Filtration Rate using the
Modification of Diet in Renal Disease (MDRD) Study equation, greater than 60mL/min.

- Use of a medically highly effective of birth control during the study and for ninety
(90) days thereafter for women of child-bearing potential (including female subjects
and female partners of non-sterile male subjects)

- Willing to allow his or her general practitioner and consultant, if appropriate, to
be notified of participation in the study

Exclusion Criteria:

- Any concomitant disease or disorder that has symptoms of spasticity or that may
influence the subject's level of spasticity

- Inability to rate their level of spasticity or distinguish it from other MS symptoms

- Acute MS exacerbation requiring treatment within twelve (12) weeks of screening

- Use of intravenous methylprednisolone within the twelve (12) weeks before visit 1

- Concomitant use of medications that would potentially interfere with the actions of
the study medication or outcome variables

- Use of botulinum toxin A or B within six (6) months of visit 1

- History of allergy to baclofen or any inactive component of test or reference
formulation

- Pregnancy, lactation or planned pregnancy during the course of the study and for
three (3) months thereafter.

- History of unstable psychiatric disease, or current signs and symptoms of significant
medical disorders such as severe, progressive, or uncontrolled pulmonary, cardiac,
gastrointestinal, hepatic, renal, genitourinary, hematological, endocrine,
immunologic, or neurological disease

- History of seizures

- Current significant cognitive deficit, severe or untreated anxiety, severe or
untreated depression

- Subjects with abnormal micturition that requires indwelling or intermittent
catheterization or with lower urinary tract symptoms (LUTS) that result in a score
greater than twenty-six (>26) in the Baseline USP© questionnaire

- Current malignancy or history of malignancy that has not been in remission for more
than five (5) years, except effectively treated basal cell skin carcinoma

- Any other significant disease, disorder or significant laboratory finding which, in
the opinion of the investigator, put the subject at risk because of participation,
influence the result of the study, or affect the subject's ability to participate

- Planned elective surgery or other procedures requiring general anesthesia during the
study

- Subject who is inappropriate for placebo medication in the judgment of the
Investigator

- History of substance abuse within the past twelve (12) months

- Current chronic use of long acting opioids or round the clock use of short acting
opioids for the treatment of pain

- Participation in another research study within thirty (30) days of Screening

- Patients who are uncooperative or unwilling to sign consent form