NEREUS
Generic: TRADIPITANT
Basic Information
Manufacturer
Vanda Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
1a021ebd-16ac-4354-b4b2-1c3950c091e5
Indications & Usage
1 INDICATIONS AND USAGE NEREUS is indicated for the prevention of vomiting induced by motion in adults.
NEREUS is a substance P/neurokinin 1 (NK1) receptor antagonist indicated for the prevention of vomiting induced by motion in adults.
( 1 )
NEREUS is a substance P/neurokinin 1 (NK1) receptor antagonist indicated for the prevention of vomiting induced by motion in adults.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥5%) are: somnolence, headache, and fatigue.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc.
at 1-844-GO-VANDA (1-844-468-2632) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of a single 85 mg or 170 mg dose of NEREUS was evaluated in adult subjects with a history of motion sickness in two randomized, double-blind, placebo-controlled trials, Study 1 and Study 2 [see Clinical Studies (14) ] .
Additional safety data for the 170 mg dose of NEREUS were obtained from a randomized, double-blind, placebo-controlled trial, Study 3 (NCT03772340).
Adverse reactions reported in at least 5% of subjects treated with a single NEREUS 85 mg or 170 mg dose and at a higher frequency than subjects who received placebo, are shown in Table 1 .
Table 1: Adverse Reactions a in Adult Subjects with a History of Motion Sickness in Single-Dose, Placebo-Controlled Studies Among Subjects Receiving NEREUS a Reported in at least 5% of subjects and at a higher frequency than placebo.
b NEREUS was administered as a single 85 mg dose approximately 60 minutes prior to a boat trip and without food.
c NEREUS was administered as a single 170 mg dose approximately 60 minutes prior to a boat trip and without food.
Studies 1 and 2 Studies 1, 2, and 3 Adverse Reaction NEREUS 85 mg b N=227 n (%) Placebo N=228 n (%) NEREUS 170 mg c N=289 n (%) Placebo N=291 n (%) Somnolence 14 (6) 9 (4) 36 (12) 17 (6) Headache 16 (7) 12 (5) 28 (10) 17 (6) Fatigue 14 (6) 6 (3) 24 (8) 6 (2) In a 12-month randomized, open-label study, 382 subjects with a history of motion sickness were instructed to administer NEREUS 85 mg (N=199) or 170 mg (N=183) as a single dose 60 minutes before a travel event of at least 60 minutes in duration expected to induce symptoms of motion sickness.
Subjects were allowed to take up to 90 doses during the study.
The median exposure was 18 doses and the majority of subjects (69%) did not take more than 30 doses.
Most subjects (95%) did not take more than 8 doses in any 30-day period.
Adverse reactions were consistent with those observed in Study 1, Study 2, and Study 3.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc.
at 1-844-GO-VANDA (1-844-468-2632) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of a single 85 mg or 170 mg dose of NEREUS was evaluated in adult subjects with a history of motion sickness in two randomized, double-blind, placebo-controlled trials, Study 1 and Study 2 [see Clinical Studies (14) ] .
Additional safety data for the 170 mg dose of NEREUS were obtained from a randomized, double-blind, placebo-controlled trial, Study 3 (NCT03772340).
Adverse reactions reported in at least 5% of subjects treated with a single NEREUS 85 mg or 170 mg dose and at a higher frequency than subjects who received placebo, are shown in Table 1 .
Table 1: Adverse Reactions a in Adult Subjects with a History of Motion Sickness in Single-Dose, Placebo-Controlled Studies Among Subjects Receiving NEREUS a Reported in at least 5% of subjects and at a higher frequency than placebo.
b NEREUS was administered as a single 85 mg dose approximately 60 minutes prior to a boat trip and without food.
c NEREUS was administered as a single 170 mg dose approximately 60 minutes prior to a boat trip and without food.
Studies 1 and 2 Studies 1, 2, and 3 Adverse Reaction NEREUS 85 mg b N=227 n (%) Placebo N=228 n (%) NEREUS 170 mg c N=289 n (%) Placebo N=291 n (%) Somnolence 14 (6) 9 (4) 36 (12) 17 (6) Headache 16 (7) 12 (5) 28 (10) 17 (6) Fatigue 14 (6) 6 (3) 24 (8) 6 (2) In a 12-month randomized, open-label study, 382 subjects with a history of motion sickness were instructed to administer NEREUS 85 mg (N=199) or 170 mg (N=183) as a single dose 60 minutes before a travel event of at least 60 minutes in duration expected to induce symptoms of motion sickness.
Subjects were allowed to take up to 90 doses during the study.
The median exposure was 18 doses and the majority of subjects (69%) did not take more than 30 doses.
Most subjects (95%) did not take more than 8 doses in any 30-day period.
Adverse reactions were consistent with those observed in Study 1, Study 2, and Study 3.