Alzheimer's patch gets stuck into US market
has been approved in the US.
The Novartis drug, Exelon Patch (rivastigmine transdermal system), will become the alternative to the Exelon oral capsule, with studies showing the patch to have a similar efficacy to the capsules while minimising the side effects of nausea and vomiting.
"Exelon Patch addresses an important medical need by delivering a proven drug in an entirely new form that meets the needs of the patients and their caregivers," Novartis Pharma global head of development James Shannon said in a statement.
The novel approach to treating the degenerative disease allows for a smooth and continuous delivery of medication through the skin over a 24 hour period, with the patch being applied to the back, chest or upper arm.
Rivastigmine is a cholinesterase inhibitor (ChEIs) which increases the activity of the neurotransmitter acetylcholine in the brain, and as a treatment, is often associated with gastrointestinal side effects.
But the recommended dose of the Exelon Patch (9.5mg/24 hours) reduced the side effects with three times fewer reports of nausea and vomiting than with the capsule form of the drug.
The patch also allows a higher proportion of patients to receive therapeutic doses compared to the capsule form of the medication.
The problems with treatments in the past have been associated with older patients who have trouble swallowing the pills.
The patch overcomes this and gives visual reassurance that the medication has been administered.
Clinical trials involving nearly 1,200 patients produced positive results, with 70 per cent of caregivers preferring the patch as a method of drug delivery.
That, coupled with the US approval of the patch makes it a strong market contender against Pfizer's Aricept (donepezil) which is currently dominating the more than €1.5bn Alzheimer's disease market.
Approximately 18 million people worldwide suffer from the progressive, degenerative disease that is characterised by impaired memory, thinking and behaviour.
This figure is expected to increase three to four fold in the next 50 years.
Beside Exelon and Aricept, Alzheimer's treatments include Ortho-McNeil's Razadyne/Reminyl (galantamine) and Forest Laboratories' Namenda (memantine).
Earlier this year, US researchers developed a transdermal vaccine for Alzheimer's disease, which triggers the immune system to clear amyloid beta, a protein found in abnormal quantities in brains of Alzheimer's patients.
The US Food and Drug Administration (FDA) also approved the use of Exelon Patch in treating patients with mild to moderate Parkinson's disease dementia.
The progressive neurological condition is characterised by impairments in executive function, memory retrieval and attention, in patients with an established diagnosis of Parkinson's disease for at least two years.
The medication was submitted for review in the European Union late last year.
