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This is the latest drug making news in the MS community. Note that this drug, which helps people with multiple sclerosis walk better, is said to work among all types of MS, not just relapse remitting. It could be close to release, as the results are from a Phase III study published in the Lancet. - Dave
4-Aminopyridine Improves Walking Ability in Some Patients With MS
NEW YORK -- February 26, 2009 -- The drug 4-aminopyridine (Fampridine) improves walking ability in some patients with multiple sclerosis (MS) and seems to be well tolerated in patients with all disease course types of MS, according to a phase 3 study published in the February 28 issue of The Lancet.
Andrew Goodman, MD, University of Rochester Medical Center, Rochester, New York, and colleagues conducted a randomised trial to assess the efficacy and safety of slow-release 4-aminopyridine on walking ability and leg strength in patients with MS at 33 centres in the United States and Canada. Patients were eligible if they had any disease course of MS and were able to complete 2 trials of the timed 25-foot walk (T25FW).
A total of 301 patients aged 18 to 70 years were randomised to receive either 4-aminopyridine 10 mg BID or a placebo for 14 weeks. Patients were assessed for walking speed measured with the T25FW at 2 weeks, and then every 4 weeks for 14 weeks. The 12-item Multiple Sclerosis Walking Scale (MSWS-12) was also used to measure the patients' perception of the effect that difficulties in walking were having on them.
Findings showed that the number of timed walk responders (patients who achieved a faster walking speed in at least 3 of the 4 assessments when they were on treatment compared with the fastest when they were not on treatment) was significantly higher in the 4-aminopyridine-treatment group (78/224; 35%) compared with the placebo group (6/72; 8%).
In addition, among the responders taking 4-aminopyridine, improvement in walking speed compared with placebo was 25.5% versus 4.7%. Improvement in leg strength was also greater in 4-aminopyridine-treated patients than in people on placebo. Further, timed walk responders reported a greater improvement in all 12 items on the MSW scale compared to timed walk nonresponders -- so responder did translate into an improvement in patients' perception.
The authors reported that 11 patients in the 4-aminopyridine group (5%) were withdrawn from the study due to adverse events, with 8 of those (4%) involving treatment-emergent events. Only 2 serious adverse events (focal seizure and severe anxiety) were considered as being connected with the drug. However, the authors pointed out that risk of seizure shown in previous studies seems to increase in a dose-dependent way with 4-aminopyridine.
"Treatment with 4-aminopyridine produces clinically meaningful improvement in walking ability in some people with multiple sclerosis, irrespective of disease course type or concomitant treatment with immunomodulators," the authors concluded.
In an accompanying comment, Alan Thompson, MD, University College London, London, United Kingdom, and Chris Polman, MD, VU Medical Centre, Amsterdam, the Netherlands, welcome the findings but add that: "Better understanding of the treatment profile, in terms of the full functional treatment effect and identification of those most likely to respond, is needed to allow for effective implementation in treatment regimens for multiple sclerosis."
SOURCE: The Lancet
4-Aminopyridine Improves Walking Ability in Some Patients With MS
NEW YORK -- February 26, 2009 -- The drug 4-aminopyridine (Fampridine) improves walking ability in some patients with multiple sclerosis (MS) and seems to be well tolerated in patients with all disease course types of MS, according to a phase 3 study published in the February 28 issue of The Lancet.
Andrew Goodman, MD, University of Rochester Medical Center, Rochester, New York, and colleagues conducted a randomised trial to assess the efficacy and safety of slow-release 4-aminopyridine on walking ability and leg strength in patients with MS at 33 centres in the United States and Canada. Patients were eligible if they had any disease course of MS and were able to complete 2 trials of the timed 25-foot walk (T25FW).
A total of 301 patients aged 18 to 70 years were randomised to receive either 4-aminopyridine 10 mg BID or a placebo for 14 weeks. Patients were assessed for walking speed measured with the T25FW at 2 weeks, and then every 4 weeks for 14 weeks. The 12-item Multiple Sclerosis Walking Scale (MSWS-12) was also used to measure the patients' perception of the effect that difficulties in walking were having on them.
Findings showed that the number of timed walk responders (patients who achieved a faster walking speed in at least 3 of the 4 assessments when they were on treatment compared with the fastest when they were not on treatment) was significantly higher in the 4-aminopyridine-treatment group (78/224; 35%) compared with the placebo group (6/72; 8%).
In addition, among the responders taking 4-aminopyridine, improvement in walking speed compared with placebo was 25.5% versus 4.7%. Improvement in leg strength was also greater in 4-aminopyridine-treated patients than in people on placebo. Further, timed walk responders reported a greater improvement in all 12 items on the MSW scale compared to timed walk nonresponders -- so responder did translate into an improvement in patients' perception.
The authors reported that 11 patients in the 4-aminopyridine group (5%) were withdrawn from the study due to adverse events, with 8 of those (4%) involving treatment-emergent events. Only 2 serious adverse events (focal seizure and severe anxiety) were considered as being connected with the drug. However, the authors pointed out that risk of seizure shown in previous studies seems to increase in a dose-dependent way with 4-aminopyridine.
"Treatment with 4-aminopyridine produces clinically meaningful improvement in walking ability in some people with multiple sclerosis, irrespective of disease course type or concomitant treatment with immunomodulators," the authors concluded.
In an accompanying comment, Alan Thompson, MD, University College London, London, United Kingdom, and Chris Polman, MD, VU Medical Centre, Amsterdam, the Netherlands, welcome the findings but add that: "Better understanding of the treatment profile, in terms of the full functional treatment effect and identification of those most likely to respond, is needed to allow for effective implementation in treatment regimens for multiple sclerosis."
SOURCE: The Lancet