Julie’s

The FDA Approves Rotigotine:<= /o:p>

What you need to know before talki= ng with your neurologist.

by Angela V. Ockerman, R.Ph.<= o:p>

In May, 2007, the Food and Drug Administration approved rotigotine (marketed u= nder the name Neupro^Ò) for release in the U.S. This is the first time a transderm= al patch has been developed and marketed for patients with Parkinson’s disease. Neurologists and pat= ients alike, are very excited about this new treatment option in the fight to mai= ntain function against this debilitating disease which, to date, remains without a cure.

How does Neupro^Ò work?

When applied to the skin, the rotigotine imbedded in the adhesive layer of the patch, crosses the skin and enters the blood stream where it is transported= to the brain. Once in the brain,= it works to stimulate the dopamine receptors which we know are affected by Parkinson’s disease. It= is similar in function to other drugs in this class of dopamine agonists such = as ropinirole (Requip^Ò), pramipexole (Mirapex^=
Ò) and apomorphine (Apokyn^=
Ò). Neupro’s^=
Ò biggest potential advantage over these agents i= s not as much in the drug itself, but in the delivery system.

When medications are taken by mouth, within a short time there is a significant = increase in the amount of drug present in the body causing the desired effect. Unfortunately, these effects do no= t last forever because our bodies are very efficient at removing chemicals, so the amount of drug decreases and the symptoms of the disease re-appear. This is often referred to as the “wearing off” time when movement can be difficult right before = the medication is taken again. As= an example, this “wearing off” can be very troublesome at night wh= ich is typically the longest period of time between doses and results in the lo= west levels of the drug. These low= drug levels make sleep uncomfortable and morning mobility especially difficult.<= span style=3D'mso-spacerun:yes'>

Not only are low drug levels a problem, but right after a dose, when drug levels are highest, Parkinson’s patients are at greatest risk for adverse dr= ug effects such as confusion, hallucinations, drowsiness and dizziness.

The Neupro^Ò patch delivers its medication in a slow continuous manner without the highs and l= ows of medications taken by mouth. By having a more consistent level of medication in your system, it should prov= ide more continuous relief from symptoms without as much risk of side effects.<= o:p>

How do I know if Neupro^Ò is right for me?

Currently, Neupro^=
Ò has only been approved in the U.S. fo= r the management of symptoms in adults with the early stages of Parkinson’s disease. In newly diagnosed patients, it can also delay the start of dopamine or L-dopa therapy (usuall= y in the form of carbidopa/levodopa marketed as Sinemet^=
Ò, Stalevo^Ò or Parcopa^Ò). Neupro^Ò is approved in Europe for use in patients with more advanced disease to be given along with dopam= ine therapy so that the dose of L-dopa can be decreased or to maintain L-dopa’s effectiveness longer. = The manufacturer intends to file an application with the U.S. Food a= nd Drug Administration for similar use in the = United States before the end = of 2007.

There are certain conditions that can increase the risk of undesired effects with Neupro^Ò. If you have any of the following conditions, you should discuss these risks with your doctor or pharmacist before beginning this type of therapy:

· Allergies to sulfites (The patch contains sodium metabisulfite.)

· Asthma=

· Difficulty controlling your blood pressure

· Heart probl= ems

· Pregnant, planning on becoming pregnant, or breastfeeding

One of the biggest risks with Neupro^Ò, like some other medications in this class, is = that it can increase your risk of being sleepy or falling asleep suddenly during normal activities. Because of= these “sleep attacks”, caution must be taken when driving, operating machinery and tools, or working on ladders. Some of these activities may need = to be stopped completely. There hav= e been reports of patients on Neupro^Ò who, without warning, have fallen asleep while driving leading to traffic accidents. It is very important that you work closely with your doctor and pharmacist to review any other medications you may be taking (either with a prescription or that you purchase on your own), which may increase the risk= of this effect.

Other possible side e= ffects include: nausea and vomiting, dizziness, hallucinations, low blood pressure (especially when standing up = from the bed or chair), compulsive behavior, and headache.

Another advantage to the drug is that it can help with what pharmacists call the “pill burden” experienced by many Parkinson’s patients. There is no pill to take. It is simply a patch that is appli= ed to the skin once daily, left on for 24 hours, then removed when a new patch is applied. Just one patch appli= ed once a day will provide 24 hours of medication.

How would I use Neupro^Ò?

Neupro^=
Ò is applied once a day to clean, dry, healthy sk= in on the stomach, thigh, hip, shoulder or upper arm. It should not be applied to areas = that will be rubbed by tight clothing or preferably, not where it can be exposed to h= igh heat. Typical heat sources to= be avoided include heating pads, electric blankets, heat lamps, saunas, hot tu= bs, heated water beds and prolonged direct sunlight. If the area you have chosen for application is very hairy, the manufacturer recommends shaving the area at least three days prior to application.&nbs= p; You may, however, bathe, shower or swim while wearing the patch. To avoid a possible burn, the patch should be removed prior to any magnetic resonance imaging (MRI) or cardioversion procedures.

It is very important that the patch be applied to a new spot each day. It should not be applied to the sa= me area of skin more than once every 14 days.= If the patches are applied to the same site repeatedly, there is a significant risk of skin rash or other reaction at that site. To apply the patch, just remove the clear plastic backing, apply to skin and hold in place for 20-30 seconds allowing the adhesive to work.

The patch should never be cut, but you must be careful when discarding the used patches. There is still some medication left in the adhesive so the used patches should be thrown away w= here children and pets cannot reach them.

How do I find out more?

Talk to your doctor or pharmacist. Neupro= â is being marketed by Schwarz Pharma, a company = known for it digestive tract and cardiovascular medications, which began providing products in the U.S.= for Parkinson’s disease with the approval of Parcopa^=
Ò (the carbidopa/levodopa medication that dissolv= es in your mouth) in August of 2004. They are currently working on a nasal spray formulation of rotigotine for the immediate treatment of Parkinson’s disease symptoms. In the meantime, Neupro= â may hit pharmacy shelves as early as July of th= is year.

References:

= 1.&n= bsp; Schwarz Pharma. Neupro^=
â package insert. Milwaukee, <= st1:State w:st=3D"on">WI: 2004, July

= 2.&n= bsp; Schwarz Pharma. Neupro^=
â patient information leaflet. Milwaukee, WI: 2004, July

= 3.&n= bsp; Food and Dr= ug Administration. Drugs@FDA. http://www.= accessdata.fda.gov/scripts/cder/drugsatfda/; Accessed May 2007

= 4.&n= bsp; Schwarz Pharma. Website information. Research and Development at http://www.sc= hwarzpharma.com/index.php?node_id=3D127 and h= ttp://www.schwarzpharma.com/sp/n2410/Parkinsons_Disease/

= 5.&n= bsp; Schwarz Pharma. Press release. FDA Approves SCHWARZ PHARMA's Neupro&re= g; (Rotigotine Transdermal System) for the Treatment of early-stage Parkinson's Disease in USA; http://www.schwarzpharma.com/_uploads/media/7400_Neupro_= US%20Approval_final_e%20.pdf; May 10, 2007

= 6.&n= bsp; Rotigotine. DrugDex Evaluations. Thomson Micromedex. Greenwood Village, CO. Available a= t: http://www.thomsonhc.com. Accessed M= ay 30, 2007.

Biography:=

Angela V. Ockerman, R.Ph. is a pharmacist with over 15 years experience in the Indianapolis area= who is currently on the faculty of the pharmaceutical sciences department for the Butler University College of Pharmacy and Health Sciences. Angela is committed to patient, caregiver, and healthcare provider education on behalf of her father and ot= hers fighting Parkinson’s disease.