NDC 0074-7096 Qulipta
Atogepant Tablet Oral

Product Information

What is NDC 0074-7096?

The NDC code 0074-7096 is assigned by the FDA to the product Qulipta which is a human prescription drug product labeled by Abbvie Inc.. The generic name of Qulipta is atogepant. The product's dosage form is tablet and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0074-7096-04 4 tablet in 1 bottle , 0074-7096-30 30 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0074-7096
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Qulipta
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Atogepant
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Abbvie Inc.
Labeler Code0074
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA215206
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
09-30-2021
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Qulipta?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
OVAL (C48345)
Size(s)6 MM
7 MM
Imprint(s)A;10
A30
Score1

Product Packages

NDC Code 0074-7096-04

Package Description: 4 TABLET in 1 BOTTLE

NDC Code 0074-7096-30

Package Description: 30 TABLET in 1 BOTTLE

Price per Unit: $33.09299 per EA

Product Details

What are Qulipta Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Qulipta Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Qulipta Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Qulipta Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



1       Indications And Usage



QULIPTA is indicated for the preventive treatment of episodic migraine in adults.


2.2       Dosage Modifications



Dosing modifications for concomitant use of specific drugs and for patients with renal impairment are provided in Table 1.

Table 1: Dosage Modifications for Drug Interactions and for Specific Populations

Dosage ModificationsRecommended Once Daily Dosage
Concomitant Drug [see Drug Interactions (7)]
       Strong CYP3A4 Inhibitors (7.1)10 mg
       Strong and Moderate CYP3A4 Inducers (7.2)30 mg or 60 mg
       OATP Inhibitors (7.3)10 mg or 30 mg
Renal Impairment [see Use in Specific Populations (8)]
       Severe Renal Impairment and End-Stage Renal
       Disease (CLcr <30 mL/min) (8.6) 
10 mg

3       Dosage Forms And Strengths



QULIPTA 10 mg is supplied as white to off-white, round biconvex tablets debossed with “A” and “10” on one side.

QULIPTA 30 mg is supplied as white to off-white, oval biconvex tablets debossed with “A30” on one side.

QULIPTA 60 mg is supplied as white to off-white, oval biconvex tablets debossed with “A60” on one side.


4       Contraindications



None.


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 QULIPTA was evaluated in 1958 patients with migraine who received at least one dose of QULIPTA. Of these, 839 patients were exposed to QULIPTA once daily for at least 6 months, and 487 patients were exposed for 12 months.

In the 12-week, placebo-controlled clinical studies (Study 1 and Study 2), 314 patients received at least one dose of QULIPTA 10 mg once daily, 411 patients received at least one dose of QULIPTA 30 mg once daily, 417 patients received at least one dose of QULIPTA 60 mg once daily, and 408 patients received placebo [see Clinical Studies (14)]. Approximately 88% were female, 80% were White, 17% were Black, and 12% were of Hispanic or Latino ethnicity. The mean age at study entry was 41 years (range 18 to 74 years).

The most common adverse reactions (incidence at least 4% and greater than placebo) are nausea, constipation, and fatigue. 

Table 2 summarizes the adverse reactions that occurred during Study 1 and Study 2.

Table 2: Adverse Reactions Occurring with an Incidence of At Least 2% for QULIPTA and Greater than Placebo in Studies 1 and 2

Placebo
(N= 408)
%
QULIPTA 
10 mg
(N=314)
%
QULIPTA 
30 mg
(N=411)
%
QULIPTA 
60 mg
(N=417)
%
Nausea3569
Constipation1666
Fatigue/Somnolence3446
Decreased Appetite<1212

The adverse reactions that most commonly led to discontinuation in Studies 1 and 2 were constipation (0.5%), nausea (0.5%), and fatigue/somnolence (0.5%).

Liver Enzyme Elevations

In Study 1 and Study 2, the rate of transaminase elevations over 3 times the upper limit of normal was similar between patients treated with QULIPTA (1.0%) and those treated with placebo (1.8%). However, there were cases with transaminase elevations over 3 times the upper limit of normal that were temporally associated with QULIPTA treatment; these were asymptomatic, and resolved within 8 weeks of discontinuation. There were no cases of severe liver injury or jaundice.

Decreases in Body Weight

In Studies 1 and 2, the proportion of patients with a weight decrease of at least 7% at any point was 2.8% for placebo, 3.8% for QULIPTA 10 mg, 3.2% for QULIPTA 30 mg, and 4.9% for QULIPTA 60 mg.


7.1       Cyp3a4 Inhibitors



Coadministration of QULIPTA with itraconazole, a strong CYP3A4 inhibitor, resulted in a significant increase in exposure of atogepant in healthy subjects [see Clinical Pharmacology (12.3)]. The recommended dosage of QULIPTA with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) is 10 mg once daily  [see Dosage and Administration (2.2)]. No dosage adjustment of QULIPTA is needed with concomitant use of moderate or weak CYP3A4 inhibitors.


7.2       Cyp3a4 Inducers



Coadministration of QULIPTA with steady state rifampin, a strong CYP3A4 inducer, resulted in a significant decrease in exposure of atogepant in healthy subjects [see Clinical Pharmacology (12.3)]. Concomitant administration of QULIPTA with moderate inducers of CYP3A4 can also result in decreased exposure of atogepant. The recommended dosage of QULIPTA with concomitant use of strong or moderate CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort, efavirenz, etravirine) is 30 mg or 60 mg once daily [see Dosage and Administration (2.2)]. No dosage adjustment of QULIPTA is needed with concomitant use of weak CYP3A4 inducers.


7.3       Oatp Inhibitors



Coadministration of QULIPTA with single dose rifampin, an OATP inhibitor, resulted in a significant increase in exposure of atogepant in healthy subjects [see Clinical Pharmacology (12.3)]. The recommended dosage of QULIPTA with concomitant use of OATP inhibitors (e.g., cyclosporine) is 10 mg or 30 mg once daily [see Dosage and Administration (2.2)].


8.1       Pregnancy



Risk Summary

There are no adequate data on the developmental risk associated with the use of QULIPTA in pregnant women. In animal studies, oral administration of atogepant during the period of organogenesis (rats and rabbits) or throughout pregnancy and lactation (rats) resulted in adverse developmental effects (decreased fetal and offspring body weight in rats; increased incidence of fetal structural variations in rabbits) at exposures greater than those used clinically [see Data].

In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.

Data

Animal Data

Oral administration of atogepant (0, 5, 15, 125, or 750 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreases in fetal body weight and in skeletal ossification at the two highest doses tested (125 and 750 mg/kg), which were not associated with maternal toxicity.  At the no-effect dose (15 mg/kg/day) for adverse effects on embryofetal development, plasma exposure (AUC) was approximately 4 times that in humans at the maximum recommended human dose (MRHD) of 60 mg/day.

Oral administration of atogepant (0, 30, 90, or 130 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in an increase in fetal visceral and skeletal variations at the highest dose tested (130 mg/kg/day), which was associated with minimal maternal toxicity. At the no-effect dose (90 mg/kg/day) for adverse effects on embryofetal development, plasma exposure (AUC) was approximately 3 times that in humans at the MRHD.

Oral administration of atogepant (0, 15, 45, or 125 mg/kg/day) to rats throughout gestation and lactation resulted in decreased pup body weight at the highest dose tested (125 mg/kg/day), which persisted into adulthood. At the no-effect dose (45 mg/kg/day) for adverse effects on pre- and postnatal development, plasma exposure (AUC) was approximately 5 times that in humans at the MRHD.


8.2       Lactation



There are no data on the presence of atogepant in human milk, the effects of atogepant on the breastfed infant, or the effects of atogepant on milk production. In lactating rats, oral dosing with atogepant resulted in levels of atogepant in milk approximately 2-fold higher than that in maternal plasma. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QULIPTA and any potential adverse effects on the breastfed infant from QULIPTA or from the underlying maternal condition.


8.4       Pediatric Use



Safety and effectiveness in pediatric patients have not been established. 


8.5       Geriatric Use



Population pharmacokinetic modeling suggests no clinically significant pharmacokinetic differences between elderly and younger subjects. Clinical studies of QULIPTA did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.


8.6       Renal Impairment



The renal route of elimination plays a minor role in the clearance of atogepant [see Clinical Pharmacology (12.3)].  In patients with severe renal impairment (CLcr 15-29 mL/min), and in patients with end-stage renal disease (ESRD) (CLcr <15 mL/min), the recommended dosage of QULIPTA is 10 mg once daily. For patients with ESRD undergoing intermittent dialysis, QULIPTA should preferably be taken after dialysis [see Dosage and Administration (2.2)]. No dose adjustment is recommended for patients with mild or moderate renal impairment.


8.7       Hepatic Impairment



No dose adjustment of QULIPTA is recommended for patients with mild or moderate hepatic impairment. Avoid use of QULIPTA in patients with severe hepatic impairment [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3)].


11       Description



The active ingredient of QULIPTA is atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of atogepant is (3'S)-N-[(3S,5S,6R)-6-methyl-2-oxo-1-(2,2,2-trifluoroethyl)-5-(2,3,6-trifluorophenyl)piperidin-3-yl]-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide, and it has the following structural formula:

The molecular formula is C29H23F6N5O3 and molecular weight is 603.5. Atogepant is a white to off-white powder. It is freely soluble in ethanol, soluble in methanol, sparingly soluble in acetone, slightly soluble in acetonitrile, and practically insoluble in water.

QULIPTA is available as tablets for oral administration containing 10 mg, 30 mg, or 60 mg atogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.


12.1       Mechanism Of Action



Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.


12.2       Pharmacodynamics



Cardiac Electrophysiology

At a dose 5 times the maximum recommended daily dose, QULIPTA does not prolong the QT interval to any clinically relevant extent.


12.3       Pharmacokinetics



Absorption

Following oral administration of QULIPTA, atogepant is absorbed with peak plasma concentrations at approximately 1 to 2 hours. Following once daily dosing, atogepant displays dose-proportional pharmacokinetics up to 170 mg (approximately 3 times the highest recommended dosage), with no accumulation.

Effect of Food

When QULIPTA was administered with a high-fat meal, the food effect was not significant (AUC and Cmax were reduced by approximately 18% and 22%, respectively, with no effect on median time to maximum atogepant plasma concentration). QULIPTA was administered without regard to food in clinical efficacy studies.

Distribution

Plasma protein binding of atogepant was not concentration-dependent in the range of 0.1 to 10 µM; the unbound fraction of atogepant was approximately 4.7% in human plasma. The mean apparent volume of distribution of atogepant (Vz/F) after oral administration is approximately 292 L.

Elimination

Metabolism

Atogepant is eliminated mainly through metabolism, primarily by CYP3A4. The parent compound (atogepant), and a glucuronide conjugate metabolite (M23) were the most prevalent circulating components in human plasma.

Excretion

The elimination half-life of atogepant is approximately 11 hours. The mean apparent oral clearance (CL/F) of atogepant is approximately 19 L/hr. Following single oral dose of 50 mg 14C-atogepant to healthy male subjects, 42% and 5% of the dose was recovered as unchanged atogepant in feces and urine, respectively.

Specific Populations

Patients with Renal Impairment

The renal route of elimination plays a minor role in the clearance of atogepant. Based on a population pharmacokinetic analysis, there is no significant difference in the pharmacokinetics of atogepant in patients with mild or moderate renal impairment (CLcr 30-89 mL/min) relative to those with normal renal function (CLcr >90 mL/min). As patients with severe renal impairment or end-stage renal disease (ESRD; CLcr <30 mL/min) have not been studied, use of the lowest effective dosage of atogepant (10 mg) is recommended in those patients  [see Dosage and Administration (2.2) and Use in Specific Populations (8.6)].

Patients with Hepatic Impairment

In patients with pre-existing mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe hepatic impairment (Child-Pugh Class C), the total atogepant exposure was increased by 24%, 15%, and 38%, respectively. Due to a potential for liver injury in patients with severe hepatic impairment, avoid use of QULIPTA in patients with severe hepatic impairment [see Use in Specific Populations (8.7)].

Other Specific Populations

Based on a population pharmacokinetic analysis, age, sex, race, and body weight did not have a significant effect on the pharmacokinetics (Cmax and AUC) of atogepant. Therefore, no dose adjustments are warranted based on these factors.

Drug Interactions

In Vitro Studies

Enzymes

In vitro, atogepant is not an inhibitor for CYPs 3A4, 1A2, 2B6, 2C8, 2C9, 2C19, or 2D6 at clinically relevant concentrations. Atogepant does not inhibit MAO-A or UGT1A1 at clinically relevant concentrations. Atogepant is not anticipated to be a clinically significant perpetrator of drug-drug interactions through CYP450s, MAO-A, or UGT1A1 inhibition.

Atogepant is not an inducer of CYP1A2, CYP2B6, or CYP3A4 at clinically relevant concentrations.

Transporters

Atogepant is a substrate of P-gp, BCRP, OATP1B1, OATP1B3, and OAT1. Dose adjustment for concomitant use of QULIPTA with inhibitors of OATP is recommended based on a clinical interaction study with a OATP inhibitor [see Dosage and Administration (2.2)].

Coadministration of atogepant with BCRP and/or P-gp inhibitors is not expected to increase the exposure of atogepant. Atogepant is not a substrate of OAT3, OCT2, or MATE1.

Atogepant is not an inhibitor of P-gp, BCRP, OAT1, OAT3, NTCP, BSEP, MRP3, or MRP4 at clinically relevant concentrations. Atogepant is a weak inhibitor of OATP1B1, OATP1B3, OCT1, and MATE1. No clinical drug interactions are expected for atogepant as a perpetrator with these transporters.

In Vivo Studies

CYP3A4 Inhibitors

Co-administration of QULIPTA with itraconazole, a strong CYP3A4 inhibitor, resulted in a clinically significant increase (Cmax by 2.15-fold and AUC by 5.5-fold) in the exposure of atogepant in healthy subjects [see Drug Interactions (7.1)].

Physiologically based pharmacokinetic (PBPK) modeling suggested co-administration of QULIPTA with moderate (e.g., cyclosporine, ciprofloxacin, fluconazole, fluvoxamine, grapefruit juice) or weak (e.g., cimetidine, esomeprazole) CYP3A4 inhibitors increase atogepant AUC by 1.7- and 1.1-fold, respectively. The changes in atogepant exposure when coadministered with weak or moderate CYP3A4 inhibitors are not expected to be clinically significant.

CYP3A4 Inducers

Co-administration of QULIPTA with rifampin, a strong CYP3A4 inducer, decreased atogepant AUC by 60% and Cmax by 30% in healthy subjects [see Drug Interactions (7.2)]. No dedicated drug interaction studies were conducted to assess concomitant use with moderate or weak CYP3A4 inducers. Moderate inducers of CYP3A4 can decrease atogepant exposure [see Drug Interactions (7.2)]. Clinically significant interaction is not expected with concomitant administration of weak inducers of CYP3A4 and QULIPTA.

BCRP/OATP/P-gp Inhibitors

Co-administration of QULIPTA with single dose rifampin, an OATP inhibitor, increased atogepant AUC by 2.85-fold and Cmax by 2.23-fold in healthy subjects [see Drug Interactions (7.3)].

Co-administration of QULIPTA with quinidine, a P-gp inhibitor, increased atogepant AUC by 26% and Cmax by 4% in healthy subjects. The changes in atogepant exposure when co-administered with P-gp inhibitors are not expected to be clinically significant.

PBPK modeling suggests that co-administration of QULIPTA with BCRP inhibitors increases atogepant exposure by 1.2-fold. This increase is not expected to be clinically significant.

Other Drug Interaction Evaluations

Co-administration of QULIPTA with oral contraceptive components ethinyl estradiol and levonorgestrel, famotidine, esomeprazole, acetaminophen, naproxen, or sumatriptan did not result in significant pharmacokinetic interactions for either atogepant or co-administered drugs.


13.1       Carcinogenesis, Mutagenesis, Impairment Of Fertility



Carcinogenicity

Atogepant was administered orally to mice (0, 5, 20, or 75 mg/kg/day in males; 0, 5, 30, 160 mg/kg/day in females) and rats (0, 10, 20, or 100 mg/kg in males; 0, 25, 65, or 200 mg/kg in females) for up to 2 years. There was no evidence of drug-related tumors in either species. Plasma exposures at the highest doses tested in mice and rats were approximately 8 and 20-35 times, respectively, that in humans at the maximum recommended human dose (MRHD) of 60 mg/day. 

Mutagenicity

Atogepant was negative in in vitro (Ames, chromosomal aberration test in Chinese Hamster Ovary cells) and in vivo (rat bone marrow micronucleus) assays.

Impairment of Fertility

Oral administration of atogepant (0, 5, 20, or 125 mg/kg/day) to male and female rats prior to and during mating and continuing in females to Gestation Day 7 resulted in no adverse effects on fertility or reproductive performance. Plasma exposures (AUC) at the highest dose tested are approximately 15 times that in humans at the MRHD.


14       Clinical Studies



The efficacy of QULIPTA for the preventive treatment of episodic migraine in adults was demonstrated in two randomized, multicenter, double-blind, placebo-controlled studies (Study 1 and Study 2). The studies enrolled patients with at least a 1-year history of migraine with or without aura, according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria.

In Study 1 (NCT03777059), 910 patients were randomized 1:1:1:1 to receive QULIPTA 10 mg (N = 222), QULIPTA 30 mg (N = 230), QULIPTA 60 mg (N = 235), or placebo (N = 223), once daily for 12 weeks. In Study 2 (NCT02848326), 652 patients were randomized 1:2:2:2 to receive QULIPTA 10 mg (N = 94), QULIPTA 30 mg (N = 185), QULIPTA 60 mg (N = 187), or placebo (N = 186), once daily for 12 weeks. In both studies, patients were allowed to use acute headache treatments (i.e., triptans, ergotamine derivatives, NSAIDs, acetaminophen, and opioids) as needed. The use of a concomitant medication that acts on the CGRP pathway was not permitted for either acute or preventive treatment of migraine. The studies excluded patients with myocardial infarction, stroke, or transient ischemic attacks within six months prior to screening.

Study 1

The primary efficacy endpoint was the change from baseline in mean monthly migraine days (MMD) across the 12-week treatment period. Secondary endpoints included the change from baseline in mean monthly headache days, the change from baseline in mean monthly acute medication use days, the proportion of patients achieving at least a 50% reduction from baseline in mean MMD (3-month average), the change from baseline in mean monthly Activity Impairment in Migraine-Diary (AIM-D) Performance of Daily Activities (PDA) domain scores, the change from baseline in mean monthly AIM-D Physical Impairment (PI) domain scores, across the 12-week treatment period, and the change from baseline at Week 12 for Migraine Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive (RFR) domain scores.  

The AIM-D evaluates difficulty with performance of daily activities (PDA domain) and physical impairment (PI domain) due to migraine, with scores ranging from 0 to 100. Higher scores indicate greater impact of migraine, and reductions from baseline indicate improvement. The MSQ v2.1 Role Function-Restrictive (RFR) domain score assesses how often migraine impacts function related to daily social and work-related activities over the past 4 weeks, with scores ranging from 0 to 100. Higher scores indicate lesser impact of migraine on daily activities, and increases from baseline indicate improvement.

Patients had a mean age of 42 years (range 18 to 73 years), 89% were female, 83% were White, 14% were Black, and 9% were of Hispanic or Latino ethnicity. The mean migraine frequency at baseline was approximately 8 migraine days per month and was similar across treatment groups. A total of 805 (88%) patients completed the 12-week double-blind study period. Key efficacy results of Study 1 are summarized in Table 3.

Table 3: Efficacy Endpoints in Study 1

QULIPTA
10 mg
N=214
QULIPTA
30 mg
N=223
QULIPTA
60 mg
N=222
Placebo
N=214
Monthly Migraine Days (MMD) across 12 weeks
Baseline7.57.97.87.5
Mean change from baseline -3.7-3.9-4.2-2.5
Difference from placebo-1.2-1.4-1.7
p-value<0.001<0.001<0.001
Monthly Headache Days across 12 weeks
Baseline8.48.89.08.4
Mean change from baseline-3.9-4.0-4.2-2.5
Difference from placebo-1.4-1.5-1.7
p-value<0.001<0.001<0.001
Monthly Acute Medication Use Days across 12 weeks
Baseline6.66.76.96.5
Mean change from baseline-3.7-3.7-3.9-2.4
Difference from placebo-1.3-1.3-1.5
p-value<0.001<0.001<0.001
≥ 50% MMD Responders across 12 weeks
% Responders56596129
Difference from placebo (%)273032
p-value<0.001<0.001<0.001
MSQ v2.1 RFR Domain* at week 12
Baseline44.944.046.846.8
Mean change from baseline30.430.531.320.5
Difference from placebo9.910.110.8
p-value<0.001<0.001<0.001
AIM-D PDA Domain** across 12 weeks
Baseline15.516.915.915.2
Mean change from baseline-7.3-8.6-9.4-6.1
Difference from placebo-1.2-2.5-3.3
p-valueNS<0.001<0.001
AIM-D PI Domain*** across 12 weeks
Baseline11.713.011.611.2
Mean change from baseline-5.1-6.0-6.5-4.0
Difference from placebo-1.1-2.0-2.5
p-valueNS0.002<0.001
* Migraine Specific Quality of Life Questionaire version 2.1 Role Function-Restrictive domain score
** Activity Impairment in Migraine-Diary Performance of Daily Activities domain score
*** Activity Impairment in Migraine-Diary Physical Impairment domain score
Not statistically significant (NS)

Figure 1 shows the mean change from baseline in MMD in Study 1. Patients treated with QULIPTA had greater mean decreases from baseline in MMD across the 12-week treatment period compared to patients who received placebo.

Figure 1: Change from Baseline in Monthly Migraine Days in Study 1

Figure 2 shows the distribution of change from baseline in mean MMD across the 12-week treatment period, in 2-day increments, by treatment group. A treatment benefit over placebo for all doses of QULIPTA is seen across a range of mean changes from baseline in MMD.

Figure 2: Distribution of Change from Baseline in Mean Monthly Migraine Days by Treatment Group in Study 1

Study 2

The primary efficacy endpoint was the change from baseline in mean monthly migraine days across the 12-week treatment period.

Patients had a mean age of 40 years (range: 18 to 74 years), 87% were female, 76% were white, 20% were Black, and 15% were of Hispanic or Latino ethnicity. The mean migraine frequency at baseline was approximately 8 migraine days per month. A total of 541 (83%) patients completed the 12-week double-blind study period.

In Study 2, there was a significantly greater reduction in mean monthly migraine days across the 12-week treatment period in all three QULIPTA treatment groups, compared with placebo, as summarized in Table 4.

Table 4: Efficacy Endpoints in Study 2

QULIPTA
10 mg
N=92
QULIPTA
30 mg
N=182
QULIPTA
60 mg
N=177
Placebo
N=178
Monthly Migraine Days (MMD) across 12 weeks
Baseline7.67.67.77.8
Mean change from baseline-4.0-3.8-3.6-2.8
Difference from placebo-1.1-0.9-0.7
p-value0.0240.0390.039
Monthly Headache Days across 12 weeks
Baseline8.98.78.99.1
Mean change from baseline-4.3-4.2-3.9-2.9
Difference from placebo-1.4-1.2-0.9
p-value0.0240.0390.039

Figure 3 shows the mean change from baseline in MMD in Study 2. Patients treated with QULIPTA had greater mean decreases from baseline in MMD across the 12-week treatment period compared to patients who received placebo.

Figure 3: Change from Baseline in Monthly Migraine Days in Study 2

 

Figure 4 shows the distribution of change from baseline in mean MMD across the 12 week treatment period, in 2-day increments, by treatment group. A treatment benefit over placebo for all doses of QULIPTA is seen across a range of mean changes from baseline in MMD.

Figure 4: Distribution of Change from Baseline in Mean Monthly Migraine Days by Treatment Group in Study 2

 


16.1       How Supplied



QULIPTA 10 mg is supplied as white to off-white, round biconvex tablets debossed with “A” and “10” on one side in the following packaging presentations:

  • Bottle of 30, NDC: 0074-7095-30
  • QULIPTA 30 mg is supplied as white to off-white, oval biconvex tablets debossed with “A30” on one side in the following packaging presentations:

    • Bottle of 30, NDC: 0074-7096-30
    • QULIPTA 60 mg is supplied as white to off-white, oval biconvex tablets debossed with “A60” on one side in the following packaging presentations:

      • Bottle of 30, NDC: 0074-7094-30

16.2       Storage And Handling



Store between 20°C and 25°C (68°F and 77°F): excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].


17       Patient Counseling Information



Advise the patient to read the FDA-approved patient labeling (Patient Information).

Drug Interactions

Inform patients that QULIPTA may interact with certain other drugs, and that dosage modifications of QULIPTA may be recommended when used with some other drugs. Advise patients to report to their healthcare provider the use of any other prescription medications, over-the-counter medications, herbal products, or grapefruit juice [see Dosage and Administration (2.2) and Drug Interactions (7.1, 7.2, 7.3)].

Manufactured by:
Forest Laboratories Ireland Ltd.
Dublin, Ireland

© 2021 AbbVie. All rights reserved.


QULIPTA™ is a trademark of Allergan Pharmaceuticals International Limited, an AbbVie company.
v1.1USPI7094


Principal Display Panel



NDC 0074-7095-30
QULIPTA™
(atogepant) tablets
10 mg

Rx Only
Contains 30 Tablets

NDC 0074-7096-30
QULIPTA™
(atogepant) tablets
Rx Only
Contains 30 Tablets

30 mg

NDC 0074-7094-30
QULIPTA™
(atogepant) tablets
Rx Only
Contains 30 Tablets

60 mg


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