A transdermal patch formulation of Novartis’ Alzheimer’s disease drug Exelon seems to offer the same efficacy as the current capsule formulation of the drug, and could make it easier for doctors to deliver effective treatment for their patients.
Novartis has just released the results of the six-month IDEAL trial of transdermal Exelon (rivastigmine) in 1,195 patients with Alzheimer’s disease, finding that compared to placebo patients on the active drug had significant improvements in memory, concentration, and their ability to carry out everyday activities.
In addition, more tan two thirds of caregivers polled in the study said they preferred the patch to capsule-based treatment, because it made it easier to follow treatment schedules, was easier to administer and caused less disruption in patient lives.
There is also the possibility that continuous administration of rivastigmine across the skin could improve the tolerability of the drug by avoiding the peaks in blood levels associated with capsule dosing, said Novartis. In IDEAL, the rate of nausea and vomiting reports was three times less with the patch than with twice-daily capsules, while efficacy was the same.
Novartis said it intends to file for approval of the new formulation before the end of the year, with a green light potentially coming just a few months later.
Meanwhile, Novartis’ arch-rival in the Alzheimer’s disease space – Japan’s Eisai – announced in May that it is developing a transdermal formulation of its rival product Aricept (donepezil) in collaboration with Nitto Denko, although this project is lagging behind Novartis’ patch.