A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis

IPX056 was compared with commercially available tablets as it was designed to provide a
prolonged duration of absorption to reduce dose frequency and/or to provide prolonged
duration of antispasticity effect.

Inclusion Criteria:

- Male or female at least 18 years old.

- Agrees to use a medically acceptable method of contraception throughout the study

- Diagnosed with MS as defined by Poser or McDonald Criteria.

- Receiving commercial baclofen tablets at a stable total daily dose ranging from 15 mg
to 80 mg in a TID dosing regimen for at least 4 weeks prior to the Screening Visit
that has resulted in improved spasticity.

- Willing to wash out and remain off other antispasticity medications during the study.

Exclusion Criteria:

- If female, the subject is pregnant, planning to become pregnant, or breastfeeding.

- History of allergy or severe intolerance to baclofen.

- Did not respond to previous baclofen treatment in any formulation.

- Has experienced an exacerbation of MS within 1 month.

- Urinary tract infection (UTI) within 2 weeks or two symptomatic UTIs within 6 months
prior to the study.

- Subjects with clinically significant impairment of renal function

- History of active seizure disorder or epilepsy, or currently taking an anticonvulsant
for treatment or control of seizure.

- Other conditions causing spasticity (e.g., stroke, cerebral palsy, traumatic brain
injury) or rigidity (e.g. Parkinson's Disease).

- Treated with Botulinum Toxin Type A or B within the previous 4 months, or with phenol
or therapeutic alcohol nerve block within 12 months or planned use of these drugs
during this study.

- Has clinically significant limitation of passive range of motion of lower
extremities.

- Has had major surgery within 6 months prior to Screening Visit that may affect
spasticity assessments such as abdominal surgery, back surgery, lower leg and knee
surgeries.