FDA Expands Exelon Patch Approval to Treat Severe Alzheimer's Disease

The US Food and Drug Administration (FDA) has expanded the indications of Novartis Pharmaceuticals Corp.’s transdermal therapy for Alzheimer’s disease to include the treatment of patients with severe stages of the neurological disorder.

Originally approved in July 2007 to treat patients with mild or moderate dementia associated with Parkinson’s disease or Alzheimer’s disease, Exelon (rivastigmine) Patch in the 13.3 milligram per 24 hours dosage form can now be administered in a wider population that includes patients with severe Alzheimer’s disease, making it the first and only skin patch with an FDA-approved indication across all stages of the neurological disorder.

"Millions of patients currently suffer from Alzheimer’s — a debilitating and heartbreaking disease marked by a decline in overall cognition and function," said Caregiver Action Network CEO John Schall said in a press release. “While there is currently no cure, there is help for patients along the journey, and new treatment options play an important role.”

A 24-week ACTION (ACTivities of Daily Living and CognitION in Patients with Severe Dementia of the Alzheimer’s Type) study determined the higher 13.3 milligram per 24 hours rivastigmine dose demonstrated greater improvement in overall cognition and daily function compared to the lower 4.6 milligram per 24 hours rivastigmine dose, according to Novartis.

While those clinical trial results formed the basis for the 15 cm² Exelon Patch’s expanded FDA approval for patients with severe Alzheimer’s disease, Novartis noted common adverse reactions — which were reported in a higher percentage of patients who received the 13.3 milligram per 24 hours dose — included redness or rash at the patch’s application site, fall, insomnia, vomiting, diarrhea, weight loss, and nausea.