Dalfampridine
Generic: DALFAMPRIDINE
Basic Information
Manufacturer
Accord Healthcare Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
354a97e8-35c8-418b-91b2-9e8e066cec65
Indications & Usage
1 INDICATIONS AND USAGE Dalfampridine Extended-Release Tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS).
This was demonstrated by an increase in walking speed [see Clinical Studies (14) ].
Dalfampridine Extended-Release Tablets are a potassium channel blocker indicated to improve walking in adult patients with multiple sclerosis (MS).
This was demonstrated by an increase in walking speed ( 1 , 14 ).
This was demonstrated by an increase in walking speed [see Clinical Studies (14) ].
Dalfampridine Extended-Release Tablets are a potassium channel blocker indicated to improve walking in adult patients with multiple sclerosis (MS).
This was demonstrated by an increase in walking speed ( 1 , 14 ).
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described in more detail elsewhere in the labeling: Seizures [see Warnings and Precautions (5.1) ] Anaphylaxis [see Warnings and Precautions (5.4) ] The most common adverse events (incidence ≥2% and at a rate greater than the placebo rate) for dalfampridine were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc.
at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In three placebo-controlled clinical trials of up to 14 weeks duration, 4% (15/400) of patients treated with Dalfampridine Extended-Release Tablets 10 mg twice daily experienced one or more adverse reactions leading to discontinuation, compared to 2% (5/238) of placebo-treated patients.
The adverse reactions leading to discontinuation of at least 2 patients treated with Dalfampridine Extended-Release Tablets and that led to discontinuation more frequently compared to placebo were headache (Dalfampridine Extended-Release Tablets 0.5%, placebo 0%), balance disorder (Dalfampridine Extended-Release Tablets 0.5%, placebo 0%), dizziness (Dalfampridine Extended-Release Tablets 0.5%, placebo 0%), and confusional state (Dalfampridine Extended-Release Tablets 0.3%, placebo 0%).
Table 1 lists adverse reactions that occurred in ≥2% of patients treated with Dalfampridine Extended-Release Tablets 10 mg twice daily, and more frequently than in placebo-treated patients, in controlled clinical trials.
Table 1: Adverse Reactions with an Incidence ≥2% of Dalfampridine Extended-Release Tablets Treated Adult MS Patients, and More Frequent with Dalfampridine Extended-Release Tablets Compared to Placebo in Controlled Clinical Trials Adverse Reaction Placebo (N=238) % Dalfampridine Extended-Release Tablets 10 mg twice daily (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 Other Adverse Reactions Dalfampridine Extended-Release Tablets have been evaluated in a total of 1,952 subjects, including 917 MS patients.
A total of 741 patients have been treated with Dalfampridine Extended-Release Tablets for over six months, 501 for over one year and 352 for over two years.
The experience in open-label clinical trials is consistent with the safety profile observed in the placebo-controlled clinical trials.
As in controlled clinical trials, a dose-dependent increase in the incidence of seizures has been observed in open-label clinical trials with Dalfampridine Extended-Release Tablets in patients with MS as follows: Dalfampridine Extended-Release Tablets 10 mg twice daily 0.41 per 100 person-years (95% confidence interval 0.13 to 0.96); dalfampridine 15 mg twice daily 1.7 per 100 person-years (95% confidence interval 0.21 to 6.28).
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use with dalfampridine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: vomiting, vertigo.
To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc.
at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In three placebo-controlled clinical trials of up to 14 weeks duration, 4% (15/400) of patients treated with Dalfampridine Extended-Release Tablets 10 mg twice daily experienced one or more adverse reactions leading to discontinuation, compared to 2% (5/238) of placebo-treated patients.
The adverse reactions leading to discontinuation of at least 2 patients treated with Dalfampridine Extended-Release Tablets and that led to discontinuation more frequently compared to placebo were headache (Dalfampridine Extended-Release Tablets 0.5%, placebo 0%), balance disorder (Dalfampridine Extended-Release Tablets 0.5%, placebo 0%), dizziness (Dalfampridine Extended-Release Tablets 0.5%, placebo 0%), and confusional state (Dalfampridine Extended-Release Tablets 0.3%, placebo 0%).
Table 1 lists adverse reactions that occurred in ≥2% of patients treated with Dalfampridine Extended-Release Tablets 10 mg twice daily, and more frequently than in placebo-treated patients, in controlled clinical trials.
Table 1: Adverse Reactions with an Incidence ≥2% of Dalfampridine Extended-Release Tablets Treated Adult MS Patients, and More Frequent with Dalfampridine Extended-Release Tablets Compared to Placebo in Controlled Clinical Trials Adverse Reaction Placebo (N=238) % Dalfampridine Extended-Release Tablets 10 mg twice daily (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 Other Adverse Reactions Dalfampridine Extended-Release Tablets have been evaluated in a total of 1,952 subjects, including 917 MS patients.
A total of 741 patients have been treated with Dalfampridine Extended-Release Tablets for over six months, 501 for over one year and 352 for over two years.
The experience in open-label clinical trials is consistent with the safety profile observed in the placebo-controlled clinical trials.
As in controlled clinical trials, a dose-dependent increase in the incidence of seizures has been observed in open-label clinical trials with Dalfampridine Extended-Release Tablets in patients with MS as follows: Dalfampridine Extended-Release Tablets 10 mg twice daily 0.41 per 100 person-years (95% confidence interval 0.13 to 0.96); dalfampridine 15 mg twice daily 1.7 per 100 person-years (95% confidence interval 0.21 to 6.28).
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use with dalfampridine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: vomiting, vertigo.