Neupro Patches (Rotigotine)

Neupro patches are transdermal patches — an adhesive patch that adheres to the skin as a way to deliver medication that treat the signs and symptoms of early and advanced-stage Parkinson’s disease. It was found, in a real-world study, to lessen symptoms, including in older patients.

The patch was developed by UCB and approved in 2012 by the U.S. Food and Drug Administration (FDA).

A generic version of Neupro patches is being developed by Vektor Pharma.

How Neupro patches work

Patients with Parkinson’s disease have reduced levels of dopamine, a naturally occurring chemical messenger found in the brain.

This is caused by the death of nerve cells that produce dopamine. Decreased dopamine levels in the brain make it difficult for Parkinson’s patients to move normally and also cause non-motor symptoms.

Neupro patches work by delivering the dopamine agonist rotigotine through the skin directly into the bloodstream. Rotigotine then stimulates dopamine receptors in the brain, mimicking the action of dopamine.

By doing that, the therapy helps to ease motor and non-motor symptoms in patients with Parkinson’s disease.

Neupro patches in trials for Parkinson’s disease

The effectiveness of Neupro for the treatment of Parkinson’s disease was studied in several different clinical trials conducted in the U.S. and abroad. Some of those trials enrolled people with early-stage Parkinson’s who were not receiving levodopa, while others enrolled patients with advanced-stage disease who were given levodopa.

In one trial, 242 individuals with early-stage Parkinson’s were treated with Neupro patches or a placebo once daily for 11 weeks, or just shy of three months. The Neupro patches contained different concentrations of rotigotine. The results revealed that Neupro was safe and significantly lessened motor symptoms.

Another study involved 277 patients with early-stage Parkinson’s who were assigned to treatment with Neupro, to a maximum dose of 6 mg/24 hours, or a placebo, for a period of up to about 28 weeks, or about seven months. Neupro was shown to be safe and to significantly lessen motor symptoms in this patient population, the results showed.

The results of an analysis of data from three Phase 3 clinical trials (NCT00244387, NCT00522379, and the PREFER study) in those with advanced Parkinson’s disease who were receiving levodopa also demonstrated the therapy’s effectiveness. Patients who added Neupro to their medication had less “off” time, or periods when symptoms are not effectively managed, compared with those taking a placebo. Additionally, these patients had increased “on” time without troublesome dyskinesia — uncontrolled movements that are a common side effect of levodopa use.

However, clinical trials often exclude some patients, including those 80 years and older. Therefore, the results may not indicate the real use or possible benefits of Neupro patches.

To fill this gap, a real-world, post-marketing surveillance study was conducted to evaluate the safety and impact of the long-term use of Neupro patches in Parkinson’s patients. This study found a lessening of symptoms in more than 70% of patients treated with Neupro patches, including those age 80 and older.

Other information

Neupro patches are a transdermal system, meaning that they stick to the skin to deliver rotigotine.

The patch is applied once daily to clean and dry skin on the front of the abdomen, thigh, hip, flank, shoulder, or upper arm. The same application sites should not be used more than once every 14 days.

The therapy exists in several strengths: 1 mg each 24 hours (mg/24h), 2 mg/24h, 3 mg/24h, 4 mg/24h, 6 mg/24h, and 8 mg/24h of rotigotine.

In early-stage Parkinson’s patients, the recommended starting dose is 2 mg/24h. Dosage may be increased every week by 2 mg/24h for additional therapeutic effect. The maximum recommended dose is 6 mg/24h.

In patients with advanced-stage Parkinson’s, the recommended starting dose is 4 mg/24h. Dosage may be increased weekly by 2 mg/24h for additional therapeutic effect. The maximum recommended dose is 8 mg/24h.

Neupro patches are contraindicated, meaning they should not be prescribed, for patients with exaggerated or inappropriate immunologic responses (hypersensitivity) to rotigotine or the components of the patch.

Side effects associated with the use of Neupro patches in Parkinson’s disease include sleepiness during daily activities, vomiting, nausea, and dizziness. Hallucinations, psychosis, and compulsive behaviors also may occur, notably in patients with advanced-stage Parkinson’s.

Application site reactions such as localized redness, swelling, or itching, are very common.

More information can be found on the treatment’s label.

 

Last updated: Feb. 16, 2022, by Teresa Carvalho MS

 


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