Numbness and Multiple Sclerosis
The National MS Society
and MS Learn Online present...
A Feature Presentation:
Dr. Stephen Krieger on:
What is numbness?
How common is numbness in MS?
How can one cope with numbness?
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Disclaimer: 'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
Posted by Stuart at August 06, 2011
Botox for Bladders: Treats Incontinence Too
(WASHINGTON) -- Botox, a drug famous for smoothing out wrinkles, could make life a little easier for people with urinary incontinence. By paralyzing the muscular lining of the bladder, the drug decreases the urgency and frequency of urination.
Botox maker Allergan has applied for Food and Drug Administration approval in people with multiple sclerosis and spinal cord injury whose conditions result in bladder overactivity.
"Those people are very much affected by this," said Caroline Van Hove, Allergan's vice president of corporate affairs. "The conditions make the bladder muscle involuntarily contract, and that causes patients to have to go to the bathroom frequently and unexpectedly."
Approval could come by the end of the year, potentially making urinary incontinence the eighth condition treated with Botox. Only one use is cosmetic; the other conditions include chronic migraine and spasticity.
"The uses of Botox are increasing," said Van Hove, adding that medical indications currently account for roughly half of the drug's $1.4 billion in worldwide sales, the remainder coming from cosmetic uses. "With the new uses, definitely that 50-50 split will sway more towards therapeutic."
There are other drugs that perform multiple roles, including a skin cancer cream used to smooth out your facial wrinkles, a baldness drug to protect against prostate cancer, and a drug for enlarged prostate and possibly prostate cancer that may stop baldness.
Once a drug has been approved for one use, doctors can prescribe it "off-label" when it is shown to be useful for something else. And an increasing number of drugs are prescribed in this manner. Off-label use of medicines accounts for about one fifth of all prescriptions, according to a 2008 study in the New England Journal of Medicine.
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UK's NHS, NOT playing Nice to Multiple Sclerosis Drug Fingolimod (Gilenya)
Article Date: 05 Aug 2011
In a draft decision, Britain's independent body that recommends whether drugs should be covered by the National Health Service, decided that at £20,000 a year fingolimod "would not be a cost effective use of NHS resources."Thousands of multiple sclerosis sufferers who do not respond to current medications were disappointed.
EU regulators gave fingolimod preliminary marketing approval at the beginning of this year. Fingolimod is made and marketed by Novartis under the brand nameGilenya. The company applied for it to be covered by the NHS for MS patients who have not responded to current medications.
The National Institute for Clinical Excellence's (NICE) recommendation does not mean that a drug is not approved, it only means that a drug will probably not be covered by the National Health Service (NHS) - in other words, the patient will have to pay for the prescription.
Current MS medications, such as beta interferons and Tysabri must be injected - patients either inject it themselves or have to go to hospital every few days for supervised infusion. Gilenya is an oral pill, it represents a considerable change in MS treatment.
According to an article in NEJM (New England Journal of Medicine), those on fingolimod had 50% fewer disabling relapses compared to those on interferon beta.
Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE said:
"While it's important that people with multiple sclerosis have treatment options, NICE has to ensure that the NHS provides treatments that bring benefits that are value for money. This is so that everyone who uses the NHS can receive the best care possible.
Unfortunately our independent committee wasn't given sufficient evidence to show that fingolimod could reduce relapses considerably better than the other treatments currently being used. Based on the available clinical evidence and economic analysis, our independent committee concluded that fingolimod would not be effective good use of NHS resources.
We encourage healthcare professionals, people with MS and our other relevant third parties to comment on our committee's provisional recommendation so that they can contribute to the development of this guidance."
There will now be a consultation. However, if the decision does not change, then the only way an MS patient will get fingolimod costs covered is if their PCT or hospital makes an exception and pays for it - resulting in a postcode lottery.
The triggers for Multiple Sclerosis - Interview with Professor Anne-Louise Ponsonby, Head Environmental and Genetic Epidemiology Research Group
FDA Okays New Label Claim for Fingolimod (Gilenya)
By John Gever, Senior Editor, MedPage Today
The oral multiple sclerosis drug fingolimod (Gilenya) reduces T1 gadolinium-enhancing lesions on MRI scans, according to new label language cleared by the FDA.
Previously the drug was approved to reduce the frequency of disease flares in relapsing forms of MS.
Safety information in fingolimod's label has also been revised to correct the time frame in which liver enzyme levels are most often elevated -- usually within six to nine months after treatment begins, according to the drug's manufacturer, Novartis.
The drug, which was approved last year, initially had label language indicating that liver transaminase elevations were most likely to be seen in the first three to four months.
Other postmarketing safety data on fingolimod have been consistent with the current label, Novartis said.
To support the new efficacy claim, Novartis submitted findings from two previously reported phase III clinical trials -- the one-year TRANSFORMS study and the two-year FREEDOMS study.
In the active-controlled TRANSFORMS trial, mean T1 gadolinium-enhancing lesion counts were 0.2 after 12 months in fingolimod-treated patients, compared with 0.5 among patients receiving interferon-beta-1a (P<0.001).
Mean lesion counts at two years in the placebo-controlled FREEDOMS study were 0.2 with fingolimod versus 1.1 in the placebo group (P<0.001).
Fingolimod, a sphingosine-1-phosphate receptor modulator, is believed to work by keeping activated T cells from leaving the lymph nodes, thereby inhibiting the autoimmune attack on nerve fibers
My thanks to Cherie C. Binns RN BS MSCN for providing the information found above.
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