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  1. Development & Approval Process | Drugs

Drug Trials Snapshots: NURTEC ODT

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the NURTEC ODT Package Insert for complete information.

NURTEC ODT (rimegepant)
NUR-tek ODT
Biohaven Pharmaceutical Inc.
Approval date: February 27, 2020


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

NURTEC ODT is a drug used for treatment of acute migraine with or without aura in adults.

A migraine is a type of headache that, in addition to pain, can be associated with nausea, vomiting, and sensitivity to light or sound. Some patients may experience an aura, which may consist of a temporary visual disturbance, or other symptoms shortly before the onset of the headache.

How is this drug used?

NURTEC ODT is a tablet taken by mouth once a day, as needed.

What are the benefits of this drug?

A higher percentage of patients did not have a headache two hours after taking NURTEC ODT compared to patients who took a placebo. Also, a higher percentage of patients who took NURTEC ODT did not have their most bothersome migraine-associated symptom (e.g., light sensitivity, nausea, or sound sensitivity) two hours after taking the drug, in comparison to patients who received placebo.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex:  NURTEC ODT worked similarly in men and women.
  • Race:  NURTEC ODT worked similarly across racial groups.
  • Age:  NURTEC ODT worked similarly among patients younger and older than 40 years of age. The number of patients 65 years and older was limited; therefore, differences in how NURTEC ODT worked between patients younger and older than 65 years of age could not be determined.

What are the possible side effects?

NURTEC ODT may cause severe allergic reactions.

The most common side effect of NURTEC ODT is nausea.

Were there any differences in side effects among sex, race and age?

  • Sex:  The occurrence of side effects was similar in men and women.
  • Race:  The occurrence of side effects was similar across racial groups.
  • Age: The occurrence of side effects was similar among patients younger and older than 40 years of age. The number of patients 65 years and older was limited; therefore, differences in side effects between patients younger and older than 65 years of age could not be determined.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the trials?

The FDA approved NURTEC ODT based on evidence from one clinical trial (Trial 1/NCT03461757) of 1351 patients with migraine headaches. Trial was conducted at 69 sites in the United States.

Figure 1 summarizes how many men and women were in the clinical trial.

Figure 1. Demographics by Sex (efficacy population)

Pie chart summarizing how many men and women were in the clinical trial. In total, 1147 women (85%) and  men (13%) participated in the clinical trial.

Adapted from FDA Statistical Review

Figure 2 summarizes the percentage of patients by race in the clinical trial.

Figure 2. Demographics by Race (efficacy population)

Pie chart summarizing the percentage of patients by race enrolled in the clinical trial. In total, 1017 White (75%), 266 Black or African American  (20%), 27 Asian (2%), 16 Native and Pacific Islander (1%) and 25 Other (2%).

* All Other includes American Indian or Native Alaskan, Multiple and Other

Adapted from FDA Statistical Review

Figure 3 summarizes the percentage of patients by age in the clinical trial.

Figure 3. Demographics by Age (efficacy population)

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total,  737 (55%) were 18 to 40 years, 585 were 41 to 64 years (43%), 29 were 65 years and older (2%).

Adapted from FDA Statistical Review

Figure 4 summarizes the percentage of patients by ethnicity in the clinical trial.

Figure 4. Demographics by Ethnicity (efficacy population)

Pie charts summarizing how many individuals of certain ethnicity were enrolled in the clinical trial. In total,  251 patients were Hispanic or Latino (19%), and 1100 (19%) patients were not Hispanic or Latino

Adapted from FDA Statistical Review

How were the trials designed?

The efficacy and safety of NURTEC ODT were evaluated in one trial of patients with migraine headache with or without aura.

Patients were instructed to treat moderate to severe migraine headache pain with one dose of NURTEC ODT or placebo. Neither the patients nor the health care providers knew which treatment was being given until after the trials were completed. Use of other drugs (i.e., Advil, Tylenol, and/or drugs to treat nausea) was allowed 2 hours after the initial treatment. 

The benefit of NURTEC ODT was assessed based on the percentage of patients who became pain free within 2 hours and comparing it with placebo-treated patients. The assessment also included the percentage of patients who were free of their most bothersome migraine symptom within 2 hours of taking the trial drug.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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