FDA approves patch to treat all stages of Alzheimer’s

The FDA recently approved a high-dose rivastigmine patch for the treatment of severe Alzheimer’s disease, expanding the patch’s approved indication to treat all stages of the disorder, according to a press release from Novartis, which is marketing the new treatment.

“This approval is a significant milestone in the treatment of Alzheimer’s disease,” said Andre Wyss, president of Novartis Pharmaceuticals Corporation. “With this expanded indication, Exelon Patch can now address a wider range of Alzheimer’s patients, including the large population of people in the severe stage of the disease.”

The FDA has already approved the Exelon Patch (13.3 mg for 24 hours) to treat mild to moderate dementia associated with Alzheimer’s disease and mild to moderate dementia associated with Parkinson’s disease.

The patch’s approval was based on a 24-week randomized, double blind study, which demonstrated significant improvement in overall cognition and function in patients with severe Alzheimer’s disease vs. the lower-dose patch (4.6 mg for 24 hours). Adverse events included erythema, falling, insomnia, vomiting, diarrhea, weight loss and nausea, which were observed in more patients assigned the higher dose compared with those who received the lower dose.

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