The U.S.
Food and Drug Administration (FDA) has approved RYTARY™ (pronounced
rye-TAR-ee), a new, extended-release formulation of carbidopa-levodopa, for the
treatment of several different types of parkinsonism, including:
- Idiopathic Parkinson’s disease (PD),
- Post-encephalitic parkinsonism, and
- parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication.
…RYTARY…provides an extended-release
carbidopa-levodopa product that treats Parkinson's disease. RYTARY is designed to address one of the most
significant unmet needs for patients living with Parkinson's disease, which is
to reduce the amount of time during the day when their symptoms are not
adequately controlled.
RYTARY combines
a mixture of immediate and extended-release carbidopa/levodopa. It consists of dozens
of tiny beads in a gelatin capsule.
RYTARY can be taken as the capsule or the capsule can be opened and the
beads mixed with an easier to swallow substance such as applesauce.
In clinical
trials*, RYTARY showed positive changes in the ability of patients with PD ability
to perform activities of daily life and increased motor skills as measured by
the Unified Parkinson's Disease Rating Scale (UPDRS) from baseline to 30 weeks
(or early termination). In addition, in patients
with advanced PD, treatment with RYTARY reduced the percentage of
"off" time compared with immediate-release carbidopa-levodopa and increased
"on" time. During the
increased “on” time, there was no increase in troublesome dyskinesia, a common
side effect in PD patients taking large doses of carbidopa/levodopa.
The most
common adverse reactions of subjects involved in the clinical RYTARY trials were
nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia,
anxiety, constipation, vomiting, and orthostatic hypotension.
RYTARY is
expected to be available for commercial distribution in February 2015.
Please see
the attached release sheet from the FDA.
If you are
interested in adding RYTARY to your PD medication regimen, please consult your neurologist.
Stay Active!
PDCRC Team
