Impact of extended-release dalfampridine on walking ability in patients with multiple sclerosis

Figures & data

Figure 1 Molecular structure of 4-aminopyridine.

Table 1 Dalfampridine pharmacokinetic parameters

Value by dalfampridine dose, mean (SE)
Pharmacokinetic parameter	5 mg	10 mg	15 mg	20 mg
Tmax, h	3.88 (0.20)	3.92 (0.25)	3.36 (0.25)	3.57 (0.25)
Cmax, ng/mL	13.13 (0.64)	25.23 (1.39)	37.00 (1.99)	49.23 (3.16)
AUC, ng · h/mL	122.1 (9.4)	252.2 (15.6)	394.4 (22.2)	511.3 (27.7)
AUC 0→∞, ng · h/mL	146.4 (10.0)	283.2 (18.0)	428.9 (25.6)	546.7 (31.4)

Copyright© 2009. Elsevier. Adapted with permission from Vollmer T, Henney HR. Pharmacokinetics and tolerability of single escalating doses of fampridine sustained-release tablets in patients with multiple sclerosis: a phase 1–11, open-label trial. Clin Ther. 2009;31: 2206–2214.⁴⁷

Table 2 Adverse reactions occurring in ≥2% of patients treated with dalfampridine ER tablets and more frequently than placebo-treated patients in clinical trials

	Placebo (N = 238)	Ampyra 10 mg every 12 h (N = 400)
Urinary tract infection	8	12
Insomnia	4	9
Dizziness	4	7
Headache	4	7
Nausea	3	7
Asthenia	4	7
Back pain	2	5
Balance disorder	1	5
Multiple sclerosis relapse	3	4
Paresthesia	3	4
Nasopharyngitis	2	4
Constipation	2	3
Dyspepsia	1	2
Pharyngolaryngeal pain	1	2

Notes: Numbers represent percentage of subjects experiencing the adverse reaction. Adapted from United States Food and Drug Administration: Prescribing Information for Ampyra^™ (dalfampridine) extended release tablets. www.accessdata.fda.gov/drugsatfda_docs/label/.../022250s000lbl.pdf. Accessed March 24, 2011.⁵¹

VollmerTHenneyHRPharmacokinetics and tolerability of single escalating doses of fampridine sustained-release tablets in patients with multiple sclerosis: a phase 1–11, open-label trialClin Ther2009312206221419922891

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United States Food and Drug Administration: Prescribing Information for Ampyra™ (dalfampridine) extended release tablets www.accessdata.fda.gov/drugsatfda_docs/label/.../022250s000lbl.pdf. Accessed March 24, 2011.

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