Fampridine Newbury
Prolonged-release tablets for improving walking in multiple sclerosis
Quick Facts About Fampridine Newbury
Key Takeaways About Fampridine Newbury
- Improves walking in MS: Fampridine Newbury is specifically designed to help adults with multiple sclerosis who experience difficulty walking, with clinical trials showing improvement in 35–43% of patients
- Strict dosing schedule: Take exactly one 10 mg tablet twice daily, 12 hours apart — never take more than two tablets per day as overdose can cause seizures
- Two-week trial: If no noticeable improvement in walking is observed within the first 2 weeks, treatment should be reconsidered with your doctor
- Kidney function matters: Fampridine is primarily excreted by the kidneys, and reduced kidney function can lead to dangerous plasma levels — regular kidney monitoring may be necessary
- Seizure risk: The most serious potential side effect is seizures, particularly if the dose is exceeded or kidney function is impaired
What Is Fampridine Newbury and What Is It Used For?
Fampridine Newbury is a potassium channel blocker prescribed to improve walking ability in adult patients with multiple sclerosis (MS) who have walking disability. It contains fampridine 10 mg in a prolonged-release formulation that provides controlled drug release over approximately 12 hours.
Fampridine, also known as 4-aminopyridine or dalfampridine, has been a significant advancement in the symptomatic management of multiple sclerosis. Unlike disease-modifying therapies that aim to reduce the frequency and severity of MS relapses, fampridine targets a specific and often debilitating symptom of the disease: impaired walking ability. Walking difficulty affects the majority of MS patients at some point during their disease course and has a profound impact on independence, quality of life, and the ability to perform daily activities.
The mechanism of action of fampridine is elegantly linked to the underlying pathophysiology of MS. In multiple sclerosis, the immune system damages the myelin sheath that insulates nerve fibres in the central nervous system. When myelin is lost (a process called demyelination), potassium ions leak out through exposed potassium channels on the nerve fibre surface, disrupting the normal transmission of electrical signals. Fampridine selectively blocks these voltage-dependent potassium channels, thereby prolonging repolarization and enhancing action potential formation in demyelinated axons. This improved nerve signal conduction translates into better coordination and strength of the muscles involved in walking.
Clinical trials have demonstrated that approximately 35–43% of MS patients treated with fampridine experience a clinically meaningful improvement in walking speed, as measured by the Timed 25-Foot Walk (T25FW) test. These patients, classified as “responders,” typically show a consistent improvement in walking speed throughout the treatment period. The therapeutic benefit is generally apparent within the first 2 weeks of treatment, allowing for an early assessment of whether the medication is effective for a given individual.
Fampridine Newbury is indicated for patients with all types of MS (relapsing-remitting, secondary progressive, primary progressive, and progressive-relapsing) who have walking disability, typically corresponding to an Expanded Disability Status Scale (EDSS) score between 4 and 7. It is important to note that fampridine does not treat the underlying disease process of MS and should be used as part of a comprehensive MS management strategy under the guidance of a neurologist.
Unlike disease-modifying therapies (such as interferon beta, glatiramer acetate, or monoclonal antibodies) that reduce relapses and slow disease progression, Fampridine Newbury is a symptomatic treatment that specifically targets walking impairment. It can be used alongside disease-modifying therapies as part of a comprehensive treatment plan.
What Should You Know Before Taking Fampridine Newbury?
Before starting Fampridine Newbury, your doctor must assess your kidney function and seizure history. The medication must not be used in patients with a history of seizures, moderate or severe kidney impairment, or concurrent use of other fampridine-containing products.
Fampridine Newbury is a potent pharmacological agent with a relatively narrow therapeutic window, meaning that the difference between an effective dose and a potentially harmful dose is small. For this reason, thorough medical evaluation before starting treatment is essential. Your prescribing physician will need to consider several important factors to determine whether fampridine is safe and appropriate for you.
Contraindications
Fampridine Newbury must not be used in the following situations:
- History of seizures: Fampridine lowers the seizure threshold in a dose-dependent manner. Patients with any history of epilepsy or seizures must not take this medication, as it can provoke seizure activity even at therapeutic doses
- Moderate or severe kidney impairment: Fampridine is primarily excreted by the kidneys (approximately 90% as unchanged drug). Reduced renal clearance leads to elevated plasma concentrations and significantly increased seizure risk. Patients with a creatinine clearance below 50 mL/min must not use fampridine
- Concomitant use of other fampridine products: Using Fampridine Newbury alongside any other product containing fampridine or 4-aminopyridine (including compounded preparations) is strictly prohibited due to the risk of overdose
- Hypersensitivity: Allergy to fampridine, 4-aminopyridine, or any of the excipients in the formulation
Warnings and Precautions
Several important warnings apply to the use of Fampridine Newbury. The most significant clinical concern is the risk of seizures, which is directly related to plasma drug levels. Seizures have been reported in clinical trials and post-marketing surveillance, typically in the context of overdose, renal impairment, or concomitant use of medications that lower the seizure threshold.
Patients should be aware of the following precautions:
- Renal monitoring: Kidney function should be assessed before starting treatment and monitored periodically, particularly in elderly patients or those with conditions that may affect renal function. A serum creatinine level should be obtained at baseline
- Cardiac considerations: Fampridine has been associated with mild QT prolongation in some studies. While clinically significant arrhythmias have not been commonly reported, caution is advised in patients with pre-existing cardiac conditions or those taking QT-prolonging medications
- Infections: Urinary tract infections are among the most commonly reported adverse events. Patients should report symptoms of urinary infection promptly
- Dizziness and balance: Fampridine can cause dizziness and balance disturbances, which may be difficult to distinguish from MS symptoms. Patients should exercise caution when performing activities that require alertness
- Allergic reactions: Hypersensitivity reactions including anaphylaxis and angioedema have been reported rarely in the post-marketing setting
Pregnancy and Breastfeeding
There are limited data on the use of fampridine in pregnant women. Animal studies have shown reproductive toxicity at doses that also caused maternal toxicity. As a precautionary measure, use of Fampridine Newbury is not recommended during pregnancy unless clearly necessary and the potential benefit justifies the potential risk to the foetus. Women of childbearing potential should discuss contraception with their prescribing physician.
It is not known whether fampridine is excreted in human breast milk. Given the potential for serious adverse reactions in nursing infants, a decision must be made whether to discontinue breastfeeding or to discontinue the medication, taking into account the benefit of the drug to the mother. Fampridine has been detected in breast milk in animal studies.
Never exceed the prescribed dose of one 10 mg tablet twice daily. Taking more than the recommended dose significantly increases the risk of seizures, which can be life-threatening. If you accidentally take too many tablets, seek emergency medical attention immediately.
How Does Fampridine Newbury Interact with Other Drugs?
Fampridine Newbury has clinically relevant interactions primarily with drugs that affect renal excretion (particularly OCT2 inhibitors such as cimetidine) and with other fampridine-containing products. Co-administration with drugs that lower the seizure threshold requires careful evaluation.
Understanding drug interactions is critical for the safe use of Fampridine Newbury. Because fampridine is primarily eliminated through the kidneys via a combination of glomerular filtration and active tubular secretion (mediated by the organic cation transporter 2, OCT2), any medication that affects renal clearance pathways may alter fampridine plasma levels and potentially increase the risk of adverse effects, particularly seizures.
Fampridine itself does not appear to significantly inhibit or induce major cytochrome P450 enzymes at therapeutic concentrations, which limits the potential for hepatic drug-drug interactions. However, the renal elimination pathway presents the primary concern for clinically meaningful interactions.
Major Interactions
| Interacting Drug | Mechanism | Clinical Effect | Recommendation |
|---|---|---|---|
| Other fampridine/4-AP products | Additive dose effect | Risk of overdose and seizures | Contraindicated — never combine |
| Cimetidine | Inhibits OCT2-mediated renal secretion | Increased fampridine plasma levels | Co-administration not recommended |
| Other OCT2 inhibitors | Inhibit renal tubular secretion | Increased fampridine exposure | Use with caution, monitor closely |
Other Interactions to Consider
| Interacting Drug | Mechanism | Clinical Effect | Recommendation |
|---|---|---|---|
| Drugs lowering seizure threshold (e.g. tramadol, bupropion, mefloquine) | Additive reduction of seizure threshold | Increased risk of seizures | Careful risk-benefit assessment |
| Baclofen | Both affect CNS function | Possible increased dizziness, falls | Monitor for increased CNS effects |
| Interferon beta | No direct pharmacokinetic interaction | Safe to combine | No dose adjustment needed |
| Glatiramer acetate | No direct pharmacokinetic interaction | Safe to combine | No dose adjustment needed |
It is important to inform your prescribing physician and pharmacist about all medications you are currently taking, including over-the-counter medicines, herbal supplements, and vitamins. This is especially important if you are starting or stopping any medication during fampridine treatment, as changes in kidney function or seizure threshold can alter the safety profile of this drug.
What Is the Correct Dosage of Fampridine Newbury?
The recommended dose of Fampridine Newbury is one 10 mg prolonged-release tablet taken twice daily, approximately 12 hours apart. The maximum daily dose is 20 mg (two tablets). The tablets must be swallowed whole and must not be split, crushed, or chewed.
Correct dosing of Fampridine Newbury is critical for both efficacy and safety. The prolonged-release formulation is specifically designed to deliver the drug gradually over approximately 12 hours, maintaining plasma levels within the therapeutic range while avoiding the high peak concentrations that are associated with an increased risk of seizures. Tampering with the tablet (splitting, crushing, or chewing) destroys this controlled-release mechanism and can result in rapid absorption of the full dose, leading to dangerously high plasma levels.
Adults
Standard Adult Dosage
Dose: 10 mg (one tablet) twice daily
Interval: Approximately 12 hours between doses
Administration: Swallow whole with water. Can be taken with or without food
Maximum daily dose: 20 mg (two tablets)
Assessment period: Evaluate walking improvement after 2 weeks; discontinue if no benefit observed
The initial treatment should be regarded as a therapeutic trial. Patients who do not demonstrate improvement in walking within the first 2 weeks of treatment are unlikely to benefit from continued therapy, and fampridine should be discontinued. In clinical trials, responders showed consistent improvement throughout the treatment period, while non-responders showed no meaningful change.
Fampridine can be taken with or without food. However, taking it with food may slightly delay the time to peak plasma concentration without significantly affecting the overall drug exposure. Patients should aim to maintain a consistent dosing schedule, taking their tablets at approximately the same times each day to maintain stable plasma levels.
Children and Adolescents
Paediatric Dosage
Fampridine Newbury is not recommended for use in children and adolescents below 18 years of age. The safety and efficacy of fampridine have not been established in this age group. There are no adequate data from clinical trials in paediatric patients.
Elderly Patients
Elderly Dosage Considerations
No specific dose adjustment is recommended based on age alone. However, kidney function naturally declines with age, and elderly patients are more likely to have reduced creatinine clearance. Renal function should be assessed before and during treatment in elderly patients. If creatinine clearance falls below 50 mL/min, fampridine must be discontinued.
Missed Dose
If you forget to take a dose, take it as soon as you remember — but only if it is at least 6 hours before your next scheduled dose. Do not take a double dose to make up for a missed one. If it is nearly time for your next dose, skip the missed dose and continue with your regular schedule. Never take two tablets at the same time or within a short interval, as this significantly increases the risk of seizures.
Overdose
Overdose with fampridine is a medical emergency. Symptoms may include tremor, sweating, confusion, memory loss, and seizures. Even a modest overdose (e.g. 3–4 tablets instead of 1) can provoke severe seizure activity. In post-marketing experience, the most serious overdose events involved status epilepticus. If overdose is suspected, call your local emergency number or go to the nearest emergency department immediately. There is no specific antidote for fampridine. Treatment is supportive, including seizure management with benzodiazepines.
What Are the Side Effects of Fampridine Newbury?
The most commonly reported side effects of Fampridine Newbury include urinary tract infections, insomnia, dizziness, headache, nausea, and balance problems. Seizures are a rare but serious adverse event requiring immediate discontinuation and emergency care.
As with all medicines, Fampridine Newbury can cause side effects, although not everybody experiences them. The safety profile of fampridine has been well characterised through clinical trials involving over 1,300 patients and extensive post-marketing surveillance. Most side effects are mild to moderate in severity and are often transient, resolving with continued treatment or upon discontinuation.
It is important to distinguish between side effects caused by fampridine and the symptoms of multiple sclerosis itself, as there is considerable overlap. For example, dizziness, balance problems, and urinary issues are common in MS patients regardless of treatment. Your healthcare provider can help determine whether any new symptoms are medication-related.
Very Common (may affect more than 1 in 10 people)
- Urinary tract infection
Common (may affect up to 1 in 10 people)
- Insomnia (difficulty sleeping)
- Dizziness
- Headache
- Balance disorder
- Paraesthesia (tingling or numbness)
- Tremor
- Nausea
- Vomiting
- Constipation
- Back pain
- Asthenia (weakness, fatigue)
Uncommon (may affect up to 1 in 100 people)
- Seizures (convulsions)
- Palpitations
- Dyspnoea (difficulty breathing)
- Pharyngolaryngeal pain (sore throat)
- Dyspepsia (indigestion)
- Rash
- Urticaria (hives)
Rare (may affect up to 1 in 1,000 people)
- Anaphylaxis (severe allergic reaction)
- Angioedema (swelling of face, lips, tongue)
- Status epilepticus (prolonged seizure)
If you experience a seizure while taking Fampridine Newbury, treatment must be permanently discontinued. You should not restart fampridine after a seizure has occurred. Other side effects should be reported to your healthcare provider, who can advise on whether it is appropriate to continue treatment.
Urinary tract infections are the most frequently reported adverse event in clinical trials. This is partly because MS patients already have a higher baseline incidence of urinary tract infections due to neurogenic bladder dysfunction. Nevertheless, patients should remain vigilant for symptoms such as increased urinary frequency, urgency, burning sensation during urination, or cloudy/malodorous urine, and report these to their healthcare provider promptly.
If you experience any side effects, talk to your doctor or pharmacist. You can also report side effects directly to your national pharmacovigilance authority (e.g. the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, the European Medicines Agency (EMA) in the EU, or the FDA MedWatch programme in the US). By reporting side effects, you help provide more information on the safety of this medicine.
How Should You Store Fampridine Newbury?
Store Fampridine Newbury at room temperature below 25°C in the original packaging to protect from moisture and light. Keep out of the sight and reach of children. Do not use after the expiry date stated on the packaging.
Proper storage of Fampridine Newbury is essential to maintain the integrity and efficacy of the prolonged-release formulation. The medication should be stored in its original blister packaging until ready to be taken, as the packaging provides protection against moisture and light, which can degrade the active substance and the polymer matrix responsible for the controlled-release mechanism.
Key storage guidelines include:
- Temperature: Store below 25°C (77°F). Do not refrigerate or freeze
- Moisture protection: Keep in the original blister packaging. Do not transfer to other containers, such as pill boxes, for more than a few days
- Light protection: Avoid exposure to direct sunlight or intense artificial light
- Child safety: Store out of the reach and sight of children. The tablets look similar to everyday items and accidental ingestion could be dangerous
- Expiry date: Do not use Fampridine Newbury after the expiry date printed on the blister and carton. The expiry date refers to the last day of that month
- Disposal: Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment
If you notice any visible changes in the tablets (discolouration, crumbling, unusual odour), do not take them. Return the affected tablets to your pharmacist for safe disposal and obtain a new supply.
What Does Fampridine Newbury Contain?
Each Fampridine Newbury 10 mg prolonged-release tablet contains fampridine as the active substance. The tablet uses a polymer matrix to control drug release over approximately 12 hours.
Understanding the composition of your medicine can be important, particularly if you have known allergies or intolerances to specific pharmaceutical excipients. The complete composition of Fampridine Newbury 10 mg prolonged-release tablets is as follows:
Active substance:
- Fampridine 10 mg per tablet
Typical excipients in prolonged-release fampridine formulations:
- Hypromellose (hydroxypropyl methylcellulose) — forms the prolonged-release matrix
- Microcrystalline cellulose — tablet binder and filler
- Colloidal anhydrous silica — flow agent
- Magnesium stearate — lubricant
- Film-coating constituents (hypromellose, titanium dioxide, polyethylene glycol) — protective coating
The prolonged-release formulation is an essential feature of this medication. The hypromellose polymer matrix gradually swells upon contact with gastrointestinal fluids, creating a gel barrier that controls the rate of fampridine release. This mechanism ensures that drug plasma levels remain within the therapeutic range over the 12-hour dosing interval, minimising the risk of high peak concentrations that are associated with seizure activity.
The tablets are white to off-white, oval-shaped, biconvex, and film-coated. They are debossed with identification markings for safety purposes. Each tablet is individually packaged in aluminium/aluminium blister strips to protect against moisture.
Fampridine Newbury prolonged-release tablets do not contain lactose, gluten, or sucrose. Patients with allergies to any listed excipient should consult their pharmacist or prescriber before starting treatment. Always check the patient information leaflet supplied with your medication for the complete list of ingredients specific to your product.
Frequently Asked Questions About Fampridine Newbury
Fampridine Newbury is a prescription medicine used to improve walking ability in adult patients with multiple sclerosis (MS) who have walking disability. It contains fampridine 10 mg in prolonged-release tablets and works by blocking potassium channels on demyelinated nerve fibres, thereby improving nerve signal conduction. It is suitable for all types of MS (relapsing-remitting, secondary progressive, primary progressive, and progressive-relapsing) and is typically prescribed for patients with an EDSS score between 4 and 7.
Take one 10 mg tablet twice daily, approximately 12 hours apart. Swallow the tablets whole with water — do not break, crush, dissolve, or chew them, as this would destroy the prolonged-release mechanism and could lead to dangerous peak plasma levels. You can take the tablets with or without food. Maintain a consistent daily schedule to keep blood levels stable.
The most commonly reported side effects include urinary tract infections (very common, affecting more than 1 in 10 patients), insomnia, dizziness, headache, nausea, weakness, back pain, balance problems, and tingling sensations. Most of these are mild to moderate and may improve with continued use. Seizures are a rare but serious side effect — seek immediate emergency care if a seizure occurs.
Fampridine Newbury must not be taken by patients with any history of seizures or epilepsy, those with moderate or severe kidney impairment (creatinine clearance below 50 mL/min), patients currently taking other fampridine or 4-aminopyridine-containing products, or individuals with a known allergy to fampridine or any of the tablet excipients. It is also not recommended during pregnancy or breastfeeding.
Clinical improvement in walking ability is typically assessed after 2 weeks of treatment using a standardised walking test (Timed 25-Foot Walk). If no improvement is observed during this initial trial period, your doctor will likely recommend discontinuing treatment, as patients who do not respond within 2 weeks are unlikely to benefit from continued use. Approximately 35–43% of patients show a meaningful walking improvement.
There is no specific contraindication for alcohol use with fampridine. However, both alcohol and fampridine can cause dizziness and balance problems. Combining them may worsen these effects and increase the risk of falls. Additionally, excessive alcohol consumption can impair kidney function over time, which could affect fampridine clearance. Discuss your alcohol consumption with your prescribing physician for personalised guidance.
References
- European Medicines Agency (EMA). Fampyra (fampridine) — Summary of Product Characteristics. EMA/CHMP. Last updated 2024. Available from: www.ema.europa.eu
- Goodman AD, Brown TR, Krupp LB, et al. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. The Lancet. 2009;373(9665):732–738. doi:10.1016/S0140-6736(09)60442-6
- Goodman AD, Brown TR, Edwards KR, et al. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Annals of Neurology. 2010;68(4):494–502. doi:10.1002/ana.22240
- National Institute for Health and Care Excellence (NICE). Fampridine for treating walking disability in people with multiple sclerosis. Technology Appraisal Guidance TA564. 2019.
- Hobart J, Blight AR, Goodman A, et al. Timed 25-Foot Walk: direct evidence that improving 20% or greater is clinically meaningful in MS. Neurology. 2013;80(16):1509–1517. doi:10.1212/WNL.0b013e31828cf7f3
- British National Formulary (BNF). Fampridine. National Institute for Health and Care Excellence. Accessed 2026.
- World Health Organization (WHO). ATC/DDD Index. WHO Collaborating Centre for Drug Statistics Methodology. 2025.
- Jensen HB, Ravnborg M, Dalgas U, Stenager E. 4-Aminopyridine for symptomatic treatment of multiple sclerosis: a systematic review. Therapeutic Advances in Neurological Disorders. 2014;7(2):97–113. doi:10.1177/1756285613512712
- Dunn J, Blight A. Dalfampridine: a brief review of its mechanism of action and efficacy as a treatment to improve walking in patients with multiple sclerosis. Current Medical Research and Opinion. 2011;27(7):1415–1423. doi:10.1185/03007995.2011.583229
- Ruck T, Bittner S, Simon OJ, et al. Long-term effects of dalfampridine in patients with multiple sclerosis. Journal of the Neurological Sciences. 2014;337(1–2):18–24. doi:10.1016/j.jns.2013.11.007
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, a multidisciplinary group of licensed healthcare professionals including specialists in neurology, clinical pharmacology, and pharmaceutical sciences.
Content developed by clinical pharmacologists with expertise in neurological therapeutics and MS treatment guidelines. All medical claims are evidence-based with references to peer-reviewed literature.
Independently reviewed by the iMedic Medical Review Board, comprising board-certified neurologists and clinical pharmacists, ensuring accuracy according to current EMA, FDA, and NICE guidelines.
Evidence standard: All content follows the GRADE evidence framework. Drug information is cross-referenced with the EMA Summary of Product Characteristics, FDA Prescribing Information, British National Formulary, and current peer-reviewed literature.
Conflict of interest: The iMedic Medical Editorial Team operates independently with no pharmaceutical industry funding, sponsorship, or commercial relationships that could influence editorial content.
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