FDA Approves Higher-Dose Rivastigmine Patch in Alzheimer's

Emma Hitt, PhD

Disclosures

September 04, 2012

September 4, 2012 — The US Food and Drug Administration (FDA) has approved a 13.3 mg/24 hour dosage strength of the rivastigmine transdermal system (Exelon, Novartis) for patients with mild to moderate Alzheimer's disease who are experiencing a decline in overall function and cognition.

The rivastigmine patch is already approved at doses of 4.6 mg/24 hours and 9.5 mg/24 hours for the treatment of mild to moderate dementia of the Alzheimer's disease (AD) type, and mild to moderate dementia associated with Parkinson's disease.

Approval of the new 13.3 mg/24 hour dosage was based on findings from the 48-week double-blind OPTIMA study. This trial was one of the longest double-blind cholinesterase inhibitor trials to date, according to a Novartis written release; the trial included patients with moderate AD who were already on the 9.5 mg/24 hour dose and were experiencing functional and cognitive decline.

Patients treated with the 13.3 mg/24 hour dose experienced significantly improved overall function compared with those who received the 9.5 mg/24 hour patch (P < .05), as measured by the Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living (ADCS-IADL) scale at week 48, a co-primary endpoint of the trial.

Improved cognition, the other co-primary endpoint in OPTIMA measured by the Alzheimer's Disease Assessment Scale-Cognitive (DAS-Cog), was significant at 24 weeks but not at 48 weeks.

No unexpected adverse events (AEs) leading to discontinuation were reported, and the safety profile of the higher dose was consistent with that of the lower-dose patches. AEs leading to discontinuation were documented in 9.6% of patients in the 13.3 mg/24 hour group compared with 12.7% in the 9.5 mg/24 hour group.

"Alzheimer's disease is marked by progressive symptomatic decline, resulting in an increasingly large physical and emotional challenge for the patient and caregiver," said Jeffrey Cummings, MD, director of the Cleveland Clinic Lou Ruvo Center for Brain Health, in the Novartis release. "Having multiple options for the treatment of mild to moderate Alzheimer's disease will help physicians better care for patients with the hope of improving function and cognition."

"Family caregivers play a vital role in the Alzheimer's treatment journey by working closely with healthcare providers to choose the right treatment for their loved ones," noted John Schall, chief executive officer of the National Family Caregivers Association, also in the release. "From the caregiver's standpoint, a patch can be visual evidence to help see if their loved one has actually received their medication, so to have an additional option is important."

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