- Subjects who participated in the preceding A0081244 double-blind trial and completed
at least through Visit 9 of that trial.
Subjects with painful distal sensory polyneuropathy (DSP) interested in treatment based on
investigator's clinical judgment.
Subjects who had acceptable tolerability of study drug in A0081244.
- Clinically significant or unstable conditions that, in the opinion of the
investigator, would compromise participation in the study. This includes, for
example, medical conditions such as, but not limited to: hepatic, renal, respiratory,
hematological, immunological, cardiovascular diseases, arrhythmia, inflammatory or
rheumatologic disease, active infections, symptomatic peripheral vascular disease,
psychiatric illness, and untreated endocrine disorders.
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.
- Active Acquired Immune Deficiency Syndrome (AIDS)- defining Opportunistic Infection
(OI) that requires hospitalization.