NURTEC ODT 8 Adverse Reactions

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8.1 Adverse Reaction Overview

A total of 1771 patients with migraine have been treated with NURTEC ODT or a bioequivalent oral dosage form in the acute treatment of migraine placebo-controlled registration studies. In the overall acute treatment development program, more than 954 patients were exposed for at least 12 months. Most of the adverse reactions reported were mild or moderate in severity.

8.2 Clinical Trial Adverse Reactions

Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

Acute Treatment of Migraine

The safety of NURTEC ODT for the acute treatment of migraine in adults has been evaluated in 3 randomized, double-blind, placebo-controlled trials in 1771 patients with migraine who received one 75 mg dose of NURTEC ODT or a bioequivalent tablet formulation (see 14.1 Trial Design and Study Demographics per Indication, Acute Treatment of Migraine). The most common adverse reaction was nausea. Hypersensitivity, including dyspnea and severe rash, occurred in less than 1% of patients treated with NURTEC ODT.

Adverse reactions are listed by MedDRA system organ class in Table 2.

 

Table 2 – List of adverse reactions with acute treatment

 

NURTEC ODT

n = [#]

(%)

Placebo ODT

n = [#]

(%)

Rimegepant Tablet*

n = [#]

(%)

Placebo Tablet*

n = [#]

(%)

Gastrointestinal disorders: nausea

11/682

(1.6%)

3/693

(0.4%)

15/1089

(1.4%)

11/1089

(1.0%)

* Data for tablet formulation pooled from Studies 2 and 3.

Long-term safety

Long-term safety of rimegepant was assessed in a one-year, open-label study, during which 1197 patients received an average of 6.5 rimegepant tablets per 4 weeks for at least 6 months and 954 received an average of 6.6 rimegepant tablets per 4 weeks for at least 12 months. Approximately 2.6% of subjects experienced a serious adverse event and 2.7% of patients were withdrawn from NURTEC ODT because of an adverse reaction.  The most common adverse reaction resulting in discontinuation in the long-term safety study was dizziness.  The overall safety profile in the open-label, long-term safety study was consistent with that of the placebo-controlled studies (Study 1, 2, and 3).

8.3 Less Common Clinical Trial Adverse Reactions

Hypersensitivity reactions

Hypersensitivity, including dyspnea and severe rash, occurred in less than 1% of patients treated in clinical studies. Hypersensitivity reactions can occur days after administration, and delayed serious hypersensitivity has occurred.

8.4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data

No adverse signals of concern were observed on any of the clinical laboratory assessments in the clinical program for NURTEC ODT.

8.5 Post-Market Adverse Reactions

No new adverse reactions have been identified based on cumulative international post-marketing experience and ongoing Phase 4 clinical trials.  

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8 Adverse Reactions

8.1 Adverse Reaction Overview

A total of 1771 patients with migraine have been treated with NURTEC ODT or a bioequivalent oral dosage form in the acute treatment of migraine placebo-controlled registration studies. In the overall acute treatment development program, more than 954 patients were exposed for at least 12 months. Most of the adverse reactions reported were mild or moderate in severity.

8.2 Clinical Trial Adverse Reactions

Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

Acute Treatment of Migraine

The safety of NURTEC ODT for the acute treatment of migraine in adults has been evaluated in 3 randomized, double-blind, placebo-controlled trials in 1771 patients with migraine who received one 75 mg dose of NURTEC ODT or a bioequivalent tablet formulation (see 14.1 Trial Design and Study Demographics per Indication, Acute Treatment of Migraine). The most common adverse reaction was nausea. Hypersensitivity, including dyspnea and severe rash, occurred in less than 1% of patients treated with NURTEC ODT.

Adverse reactions are listed by MedDRA system organ class in Table 2.

 

Table 2 – List of adverse reactions with acute treatment

 

NURTEC ODT

n = [#]

(%)

Placebo ODT

n = [#]

(%)

Rimegepant Tablet*

n = [#]

(%)

Placebo Tablet*

n = [#]

(%)

Gastrointestinal disorders: nausea

11/682

(1.6%)

3/693

(0.4%)

15/1089

(1.4%)

11/1089

(1.0%)

* Data for tablet formulation pooled from Studies 2 and 3.

Long-term safety

Long-term safety of rimegepant was assessed in a one-year, open-label study, during which 1197 patients received an average of 6.5 rimegepant tablets per 4 weeks for at least 6 months and 954 received an average of 6.6 rimegepant tablets per 4 weeks for at least 12 months. Approximately 2.6% of subjects experienced a serious adverse event and 2.7% of patients were withdrawn from NURTEC ODT because of an adverse reaction.  The most common adverse reaction resulting in discontinuation in the long-term safety study was dizziness.  The overall safety profile in the open-label, long-term safety study was consistent with that of the placebo-controlled studies (Study 1, 2, and 3).

8.3 Less Common Clinical Trial Adverse Reactions

Hypersensitivity reactions

Hypersensitivity, including dyspnea and severe rash, occurred in less than 1% of patients treated in clinical studies. Hypersensitivity reactions can occur days after administration, and delayed serious hypersensitivity has occurred.

8.4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data

No adverse signals of concern were observed on any of the clinical laboratory assessments in the clinical program for NURTEC ODT.

8.5 Post-Market Adverse Reactions

No new adverse reactions have been identified based on cumulative international post-marketing experience and ongoing Phase 4 clinical trials.  

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