The US Food and Drug Administration (FDA) has approved new 13.3mg/24hr dosage strength of Novartis's Exelon patch (rivastigmine transdermal system), designed for the treatment of patients with mild-to-moderate Alzheimer's disease.
The approval is based on efficacy and safety data demonstrated in the 48-week double-blind phase of the OPTIMA study, which compared13.3mg/24hr to 9.5 mg/24hr in declining mild to moderate Alzheimer's patients.
The trial met a co-primary endpoint showing a statistically significant (p<0.05) improvement in patients' overall function, compared to the 9.5mg/24hr patch, as measured by the instrumental activities of daily living scale (ADCS-IADL) at week 48.
Improvement in cognition (measured by ADAS-Cog) compared to the lower dose was statistically significant at 24 weeks but not at 48 weeks (also a co-primary endpoint), according to the company.
Cleveland Clinic Lou Ruvo Centre for Brain Health director Dr Jeffrey Cummings said; "Alzheimer's disease is marked by progressive symptomatic decline, resulting in an increasingly large physical and emotional challenge for the patient and caregiver."
National Family Caregivers Association CEO John Schall said the patch is also beneficial to family caregivers, who play a vital role in Alzheimer's treatment.
"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," Schall said.
Novartis Pharmaceuticals president Andre Wyss said; "We believe in transdermal application and the efficacy of Exelon Patch, and we are committed to continuing our research in Alzheimer's disease."
In addition to Alzheimer's disease, Exelon can be used to treat mild-to-moderate dementia associated with Parkinson's disease.
Image: Novartis headquarters in Basel, Switzerland. Photo: Courtesy of Andrew.