Exelon(R) (rivastigmine) Transdermal Patch: First and Only Skin Patch for Alzheimer's Disease Provides Novel Treatment Approach

FRIMLEY, England, October 23 /PRNewswire/ --

Exelon(R) (rivastigmine) transdermal patch, the first and only skin patch for the symptomatic treatment of mild to moderately severe Alzheimer's dementia(1), is available in the UK from today. Once-daily rivastigmine patch offers a novel and effective alternative to oral medication.

A clinical study of 1,195 people with Alzheimer's dementia demonstrated that the rivastigmine patch improves cognitive function (assessed using a tool that includes measures of orientation, memory and language), as well as a patient's ability to perform everyday activities compared to placebo(1). The study also showed that the 9.5mg/24h patch is as effective as the maximum titrated dose of rivastigmine oral capsules(1).

Applied once a day (replaced every 24 hours), the rivastigmine patch provides smooth and continuous delivery of rivastigmine through the skin, which reduces nausea and vomiting caused by peaks in medication levels when the drug is taken orally(2).

Dr Peter Connelly, Consultant in Old Age Psychiatry, Perth, Scotland comments, "The Exelon patch represents a valuable advance in the treatment of Alzheimer's disease. This formulation offers patients and their carers an effective, well-tolerated and convenient therapy option. I expect a significant proportion of carers will find the patch easier to use compared to the conventional formulation."

Family carers are the backbone of long-term care to Alzheimer's disease patients, frequently responsible for administering and managing patient medication(3). A survey conducted in over 1,000 caregivers showed that more than 70 per cent preferred the patch as a method of drug delivery compared to oral capsules(3). The most common reasons for preferring the patch were ease of following the schedule and ease of use(3).

The rivastigmine patch can be applied to the upper arm, chest or back(4). The patch may allow those caring for Alzheimer's disease patients to monitor treatment compliance because it provides visual reassurance that the medication has been taken(3). Compliance with prescribed medication regimens represents a challenge for most patients but may be particularly difficult for older people due to(5): the extent to which drug regimens interfere with daily living; lack of understanding or misinterpretation of instructions; complex and complicated drug regimens; and forgetfulness(6). 75% of older people are believed to not comply with their treatment regimens(5).

"Caring for a relative with Alzheimer's is very time-consuming and sometimes overwhelming. There's a lot to think about and sufferers are often on a number of medications," comments carer Lisa, who used to look after her sister at home. "People with the disease can find it difficult to take oral medication and to comply with a strict routine. A patch that provides 24 hour cover could help keep track of when medication has been taken."

Notes to Editors

About rivastigmine and Alzheimer's disease

Exelon(R) (rivastigmine) is recognised therapy for dementia(2). Since 1997, oral rivastigmine has been widely used to treat mild to moderate Alzheimer's disease in more than 70 countries. Rivastigmine belongs to a class of drugs known as cholinesterase inhibitors, which inhibit the breakdown of the neurotransmitter acetylcholine in the brain. Oral rivastigmine is the only cholinesterase inhibitor to be licensed for both mild to moderately severe Alzheimer's disease and Parkinson's disease dementia in Europe. Rivastigmine patch is licensed only for the symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Alzheimer's disease is a degenerative brain disorder that affects 450,000 people in the UK alone(7). It is the most common form of dementia(5) and is a progressive disease that alters the brain, causing impaired memory, thinking and behaviour. Dementia costs the UK over GBP17 billion a year(8). Family carers of people with dementia save the UK over GBP6 billion a year(8).

About IDEAL

IDEAL (Investigation of Transdermal Exelon in Alzheimer's disease) was a multi-centre, randomised, double-blind, placebo- and active-controlled 24-week trial to compare the efficacy, safety and tolerability of the once-daily rivastigmine transdermal patch with conventional twice-daily rivastigmine capsules in patients with moderate Alzheimer's disease (AD)(1). The primary outcome measures for the main IDEAL results were the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADSC-CGIC)(1). The outcome measure for the Caregiver sub-study was the Alzheimer's Disease Caregiver Preference Questionnaire (ADCPQ)(3). IDEAL was conducted in 21 countries, involving 100 centres and 1,195 patients aged 50-85 years old with a score of 10-20 in the Mini-Mental State Examination (MMSE), the most widely-used test for assessing memory problems or dementia. In this study 1,195 patients with mild-moderate AD were randomly assigned to receive a target dose of 9.5 mg/24h rivastigmine patch; 12mg/day rivastigmine capsules or placebo. For the double blind element of the study all patients received both a patch (active or placebo) which was applied every morning and capsules (active or placebo) twice daily. As normal in the treatment of AD, patients were titrated up to their target dose, which in this study was done in 4-week steps over a 16 week schedule.

Dosing

Target dose rivastigmine patch 9.5 mg/24h is discretely small, with a diameter of just 3.5 cm. Rivastigmine patch allows easy access to optimal therapeutic doses, with a simple one-step dose increase from rivastigmine patch 4.6 mg/24h to rivastigmine patch 9.5 mg/24h after a minimum of 4 weeks.

About Novartis

Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world.

For more information, please visit http://www.novartis.com

References

1. Winblad B, Cummings J, et al. A 6-Month Double-blind, Randomized, Placebo-Controlled Study of A Transdermal Patch in Alzheimer's disease - Rivastigmine Patch versus Capsule. International Journal of Geriatric Psychiatry May 2007: 22: 5:485-491

2. Oertel W, et al. Rationale for transdermal drug administration in Alzheimer disease. Neurology 2007;69 suppl1:S4-S9

3. Winblad B, Beusterien KM, et al. Caregiver preference for rivastigmine patch relative to capsules for treatment of probable Alzheimer's disease. International Journal of Geriatric Psychiatry May 2007: 22: 5: 456-67

4. Lefevre G, Sedek G, Huang HL, et al. Pharmacokinetics of a rivastigmine transdermal patch formulation in healthy volunteers: relative effects of body site application. J Clin Pharmacol 2007;47:471-8.

5. Salzman C. Medication compliance in the elderly. J Clin Psychiatry 1995;56 suppl 1:18-22

6. Ryan AA. Medication compliance and older people: a review of the literature. Int J Nurs Stud 1999;36:153-62

7. Alzheimer's Society. 'Dementia UK: The full report' Alzheimer's Scotland, 2007. Available at URL: http://www.alzscot.org/pages/policy/dementiaepidemic.htm

8. Alzheimer's Society. 'Facts about Dementia- Statistics'. Accessed in April 2007. Available at URL http://www.alzheimers.org.uk/Facts_about_dementia/Statistics/index.htm