Rx Product News: Profile: A Closer Look at New FDA Actions: Neupro

Monica Holmberg, PharmD
Published Online: Friday, February 1, 2008

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

  1. 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.
  2. Thompson C. FDA approves first Parkinson's patch. Am J Health-Syst Pharm. 2007;64:1244.
  3. 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.
  4. Neupro prescribing information. www.neupro.com/documents/Neupro+PI_071207.pdf. Accessed September 2007.


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