Over 10 years of clinical experience suggests that when standard
therapy fails ORAP may produce significantly more improvement
of symptoms(i)
Although Tourette Syndrome most often has
its onset in patients between the ages of 2 and 15 years, information
on the use and efficacy of ORAP in patients less than 12 years
of age is limited. A 24-week open-label study in 36 children
between the ages of 2 and 12 demonstrated that ORAP has a similar
safety profile in this age group as in older patients, and there
were no safety findings that would preclude its use in this age
group.
Because its use and safety have not been evaluated
in other childhood disorders, ORAP is not recommended for use
in any condition other than Tourette Syndrome.
ORAP is indicated for the suppression of motor
and phonic tics in patients with Tourette Syndrome who have failed
to respond satisfactorily to standard therapy. ORAP is not intended
as treatment of first choice.
ORAP is intended for use only in Tourette
Syndrome patients whose symptoms are severe and who cannot tolerate
or do not respond to standard treatment.
Evidence supporting approval of ORAP for use
in Tourette Syndrome was obtained in two controlled clinical
investigations that enrolled patients between the ages of 8 and
53 years. Most subjects in the two trials were 12 years or older.
ORAP is indicated for the suppression of motor
and phonic tics in patients with Tourettes Syndrome who have
failed to respond satisfactorily to standard therapy. Treatment
with ORAP may expose the patient to certain risks. Prescribers
are urged to familiarize themselves with the potential risks
before prescribing. ORAP is contraindicated in patients with
a history of cardiac arrhythmias, congenital long QT syndrome,
or concurrent use of certain medication.