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

Dr. Holmberg is a pharmacy residentat the Carl T. Hayden Veterans AffairsMedical Center in Phoenix, Arizona.

Schwarz BioScience's Neupro

Neupro (rotigotine transdermal system)by Schwarz BioScience hasreceived FDA approval for the treatmentof early symptoms of Parkinson'sdisease (PD) in adults.¹ The activeingredient of Neupro, rotigotine, isdescribed as a non-ergolinic dopamine-receptoragonist and has not been previouslyapproved in the United States.^1,2Neupro is the first PD medication to beavailable transdermally.¹ The once-dailydelivery system is promoted toprovide a continuous and constantlevel of medication to patients with PD.²

PD is estimated to affect more than1 million Americans. The conditionresults from a loss of dopamine-producingcells in the brain.¹ Four primarysymptoms are characteristic of PD:tremor (trembling of the hands, arms,legs, jaw, and face); rigidity (stiffness ofthe limbs and trunk); bradykinesia(slowness of movement); and posturalinstability (impairment of balance andcoordination).¹ Although medicationsare available to improve its symptoms,PD currently has no cure.³

Mechanism of Action

Although its exact mechanism isunknown, Neupro has been shown tobe a nonergoline D₃/D₂/D₁ dopamineagonist. It is believed to improve thesymptoms of PD through stimulation ofthe dopamine D₂ receptors in the caudate-putamen in the brain.⁴

Clinical Trials

Neupro was assessed for improvementin signs and symptoms of early-stageidiopathic PD in a totalof 3 parallel-group, randomized,double-blind, placebo-controlledstudies. Patientsin these studies were notusing concomitant medicationsto treat PD. The studiesinvolved a total of 1154patients with early PD anddetermined Neupro to beeffective in controlling symptoms.¹

Dosing

Treatment with Neuproshould be initiated at 2 mg/24 hours. Dose escalationmay occur weekly and shouldbe based on drug toleranceand lack of improvement. Ifclinically appropriate, dosesmay be increased to 4 mg/24hours after 1 week and 6 mg/24 hoursafter a second week.²

Contraindications, Warnings, and Precautions

Neupro is contraindicated inpatients with a known hypersensitivityto Neupro or any of its components.It contains sodium metabisulfate andshould be used cautiously in patientswith sensitivity to sulfites. Somnolencehas occurred commonly inpatients using Neupro, and theyshould be questioned about drowsinessand cautioned to avoid driving orengaging in any activity that requiresalertness. Hallucinations have occurredin some patients while usingthis medication.

Patients using Neupro may be at ahigher risk for developing posturalhypotension, syncope, elevated heartrate and/or blood pressure, weightgain, fluid retention, and dyskinesia.

Neupro is in pregnancy category Cand is not recommended for use inpatients who are breast-feeding.⁴

Patient Education

Patients should be counseled toapply 1 Neupro patch to a clean, dry,and intact area of skin on the abdomen,thigh, hip, flank, shoulder, orupper arm. After 24 hours, the patchshould be removed and folded so thatthe adhesive sides stick together.Thorough handwashing should beemployed after applying and removingthe patch to completely eliminate anytraces of drug residue. The site of applicationshould be rotated daily; Neuproshould not be applied to the same areamore frequently than every 14 days.

Neupro should be removed prior tomagnetic resonance imaging or cardioversion.⁴

The most common adverse reactionsare 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.