Neupro can now treat early symptoms of Parkinson's disease.
Dr. Holmberg is a pharmacy resident
at the Carl T. Hayden Veterans Affairs
Medical Center in Phoenix, Arizona.
Schwarz BioScience's Neupro
Neupro (rotigotine transdermal system)
by Schwarz BioScience has
received FDA approval for the treatment
of early symptoms of Parkinson's
disease (PD) in adults.1 The active
ingredient of Neupro, rotigotine, is
described as a non-ergolinic dopamine-receptor
agonist and has not been previously
approved in the United States.1,2
Neupro is the first PD medication to be
available transdermally.1 The once-daily
delivery system is promoted to
provide a continuous and constant
level of medication to patients with PD.2
PD is estimated to affect more than
1 million Americans. The condition
results from a loss of dopamine-producing
cells in the brain.1 Four primary
symptoms are characteristic of PD:
tremor (trembling of the hands, arms,
legs, jaw, and face); rigidity (stiffness of
the limbs and trunk); bradykinesia
(slowness of movement); and postural
instability (impairment of balance and
coordination).1 Although medications
are available to improve its symptoms,
PD currently has no cure.3
Mechanism of Action
Although its exact mechanism is
unknown, Neupro has been shown to
be a nonergoline D3/D2/D1 dopamine
agonist. It is believed to improve the
symptoms of PD through stimulation of
the dopamine D2 receptors in the caudate-putamen in the brain.4
Clinical Trials
Neupro was assessed for improvement
in signs and symptoms of early-stage
idiopathic PD in a total
of 3 parallel-group, randomized,
double-blind, placebo-controlled
studies. Patients
in these studies were not
using concomitant medications
to treat PD. The studies
involved a total of 1154
patients with early PD and
determined Neupro to be
effective in controlling symptoms.1
Dosing
Treatment with Neupro
should be initiated at 2 mg/
24 hours. Dose escalation
may occur weekly and should
be based on drug tolerance
and lack of improvement. If
clinically appropriate, doses
may be increased to 4 mg/24
hours after 1 week and 6 mg/24 hours
after a second week.2
Contraindications, Warnings, and Precautions
Neupro is contraindicated in
patients with a known hypersensitivity
to Neupro or any of its components.
It contains sodium metabisulfate and
should be used cautiously in patients
with sensitivity to sulfites. Somnolence
has occurred commonly in
patients using Neupro, and they
should be questioned about drowsiness
and cautioned to avoid driving or
engaging in any activity that requires
alertness. Hallucinations have occurred
in some patients while using
this medication.
Patients using Neupro may be at a
higher risk for developing postural
hypotension, syncope, elevated heart
rate and/or blood pressure, weight
gain, fluid retention, and dyskinesia.
Neupro is in pregnancy category C
and is not recommended for use in
patients who are breast-feeding.4
Patient Education
Patients should be counseled to
apply 1 Neupro patch to a clean, dry,
and intact area of skin on the abdomen,
thigh, hip, flank, shoulder, or
upper arm. After 24 hours, the patch
should be removed and folded so that
the adhesive sides stick together.
Thorough handwashing should be
employed after applying and removing
the patch to completely eliminate any
traces of drug residue. The site of application
should be rotated daily; Neupro
should not be applied to the same area
more frequently than every 14 days.
Neupro should be removed prior to
magnetic resonance imaging or cardioversion.4
The most common adverse reactions
are those at the patch site, dizziness,
nausea, vomiting, drowsiness,
and insomnia.1
References
- Food and Drug Administration. FDA approves Neupro patch for treatment of early Parkinson's Disease. www.fda.gov/bbs/topics/NEWS/2007/NEW01631.html. Accessed September 2007.
- Thompson C. FDA approves first Parkinson's patch. Am J Health-Syst Pharm. 2007;64:1244.
- National Institute of Neurological Disorders and Stroke. NINDS Parkinson's Disease information page. www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease.htm?css=print. Accessed September 2007.
- Neupro prescribing information. www.neupro.com/documents/Neupro+PI_071207.pdf. Accessed September 2007.
