Indications for: AMPYRA
To improve walking in patients with multiple sclerosis (demonstrated by an increase in walking speed).
The effectiveness of Ampyra in improving walking in patients with multiple sclerosis was evaluated in 2 adequate and well controlled trials involving 540 patients. Patients in these studies had a mean disease duration of 13 years and a mean Kurtzke Expanded Disability Status Scale (EDSS) score of 6.
- Randomized, placebo-controlled, parallel group, 21-week study in 301 patients with multiple sclerosis.
- A total of 283 patients (212 Ampyra and 71 placebo) completed all study visits.
- Patient inclusion criteria included the ability to walk 25 feet in 8-45 seconds.
- Exclusion criteria: History of seizures or evidence of epileptiform activity on a screening EEG, and onset of an MS exacerbation within 60 days.
- Randomized, placebo-controlled, parallel group, 14-week study in 239 patients with MS.
- A total of 227 patients (113 AMPYRA and 114 placebo) completed all study visits.
- Same inclusion and exclusion criteria as in Trial 1.
Primary endpoint: Walking speed (in feet per second) as measured by the Timed 25-foot Walk (T25FW), using a responder analysis. A responder was defined as a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no treatment visits.
Results: A significantly greater proportion of patients taking Ampyra 10mg twice daily were responders, compared with patients taking placebo (Trial 1: 34.8% vs 8.3%; Trial 2: 42.9% vs. 9.3%). Increased response rate was observed across all 4 major types of MS disease course. Compared with placebo, a significantly greater proportion of patients taking Ampyra had increases in walking speed of at least 10%, 20%, or 30% from baseline. The magnitude of improvement in walking ability was independent of concomitant drugs (63% of patients were using immunomodulatory drugs). No differences observed based on degree of impairment, age, gender, or BMI; the effect on race could not be evaluated.
Swallow whole. ≥18yrs: max 10mg every 12hrs.
<18yrs: not established.
History of seizures. Moderate or severe renal impairment (CrCl ≤50mL/min). Hypersensitivity to 4-aminopyridine.
Assess renal function before initiation; monitor at least annually. Mild renal impairment (CrCl 51–80mL/min): increased risk of seizures. Discontinue if signs/symptoms of anaphylaxis occurs. Pregnancy. Nursing mothers.
Potassium channel blocker.
Discontinue other forms of 4-aminopyridine prior to initiating. Concomitant OCT2 inhibitors (eg, cimetidine) may potentiate the risk of seizures.
UTI, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, MS relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, throat pain; seizures (possible at higher doses), severe allergic reactions.
Dalfampridine and metabolites elimination is nearly complete after 24 hours, with 95.9% of the dose recovered in urine and 0.5% recovered in feces. Elimination half-life of dalfampridine is 5.2 to 6.5 hours.
Generic Drug Availability: