AbbVie: Atogepant Outperforms Topiramate in Phase 3 Migraine Prevention Study

Overview

AbbVie (NYSE: ABBV) today announced positive topline results from its Phase 3 TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (QULIPTA® / AQUIPTA®, 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mg/day) in adult patients with a history of four or more migraine days per month.1

Result: The primary outcomes

• The study met the primary endpoint of treatment discontinuation due to adverse events (AEs), demonstrating that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, had fewer discontinuations due to AEs than topiramate, an anticonvulsant medication also approved for migraine prevention. 
• Over the 24-week double-blind treatment period, discontinuation due to AEs was significantly lower with atogepant (12.1%) compared to topiramate (29.6%), representing a relative risk of 0.41 (95% CI: 0.28, 0.59; p<0.0001).

Result: The secondary endpoints

The study also met all six secondary endpoints, including a key measure of clinical efficacy: 64.1% of patients on atogepant achieved a ≥50% reduction in mean monthly migraine days (MMD) during months 4 to 6 of the double-blind treatment period compared to 39.3% of patients on topiramate (p<0.0001).

From the CSO: AbbVie

These TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine,"" said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. ""This study demonstrates our commitment to improving treatment options and advancing care standards for people living with this debilitating disease.

About Migraine

• Migraine continues to be underdiagnosed and undertreated, despite significant burden on patients' lives.
• It is a complex neurological disease that affects approximately 14% of the global population and ranks as the second leading cause of disability worldwide. 
• Despite its prevalence and disabling impact, there are numerous gaps in patient care related to the standards for preventive treatment. 
• Notably, over 50% of people currently using preventive medications still qualify for further preventive treatment, indicating that their current therapies may not be providing sufficient relief.3

Comments from Headache Specialists of Oklahoma

• Far too often, people living with migraine struggle with meeting their treatment goals despite available and accessible preventive options,"" said Jaclyn Duvall, M.D., neurologist and founder of Headache Specialists of Oklahoma. 
• The TEMPLE data provide a patient-centered measure of treatment effectiveness by capturing both efficacy and tolerability, representing a meaningful way to evaluate the real-world impact of treatment persistence in migraine prevention.""

The AE profile of atogepant observed in this active-controlled study was generally consistent with its established safety profile from prior studies.1

Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. Atogepant is a once-daily oral CGRP receptor antagonist, proven to prevent both episodic and chronic migraine in adults.

Full results from the TEMPLE study will be presented at an upcoming medical meeting.

About the TEMPLE Study

• TEMPLE is a Phase 3, multicenter, randomized, double-blind, active-controlled trial evaluating the tolerability, safety, and efficacy of atogepant versus topiramate in adult patients with a history of four or more migraine days per month. 
• The trial randomized 545 participants with episodic or chronic migraine aged 18 and older across 73 sites in Europe, Israel and Canada.
• The study was conducted in two distinct periods. In the initial 24-week Double-Blind Treatment Period, which included a 6-week up-titration phase and an 18-week maintenance phase, participants were randomized to receive either atogepant (60 mg once daily) or the highest tolerated dose of topiramate (ranging from 50 to 100 mg/day). 
• Following this, eligible participants continued into a 52-week Open-Label Treatment Period, during which all received atogepant (60 mg once daily). 
• Throughout the study, patient reported outcomes were regularly collected and patients were continuously monitored for safety and tolerability through clinical assessments and lab tests.
• The primary endpoint was the percentage of patients who discontinued the study treatment due to AEs during the 24-week double-blind treatment period. 
• An electronic diary (eDiary) was used to collect data on headache frequency, duration, symptoms, acute medication use, and various patient-reported outcomes. 

More information on the TEMPLE trial can be found on www.clinicaltrials.gov (NCT05748483).

About Atogepant

• Atogepant is a once-daily orally administered CGRP receptor antagonist specifically developed for the preventive treatment of migraine in adults. 
• CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. 
• Studies have shown that CGRP levels are elevated during migraine attacks. Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries.

What is QULIPTA® (atogepant)?

QULIPTA is a prescription medicine used for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION FOR QULIPTA®

• Do not take QULIPTA if you have had an allergic reaction to atogepant or any ingredients in QULIPTA.
• Before taking QULIPTA, tell your healthcare provider about all your medical conditions, including if you:

-Have high blood pressure
-Have circulation problems in your fingers and toes
-Have kidney problems or are on dialysis
-Have liver problems
-Are pregnant or plan to become pregnant
-Are breastfeeding or plan to breastfeed
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. QULIPTA may affect the way other medicines work, and other medicines may affect how QULIPTA works. Your healthcare provider may need to change the dose of QULIPTA when taken with certain other medicines.

Serious side effects

QULIPTA can cause serious side effects, including:

• Allergic (hypersensitivity) reactions, including anaphylaxis: Serious allergic reactions can happen when you take QULIPTA or days after. Stop taking QULIPTA and get emergency medical help right away if you get any of the following symptoms, which may be part of a serious allergic reaction: swelling of the face, lips, or tongue; itching; trouble breathing; hives; or rash.
• High blood pressure: New or worsening of high blood pressure can happen. Contact your healthcare provider if you have an increase in blood pressure.
• Raynaud's phenomenon: A type of circulation problem can worsen or happen. Raynaud's phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur.
• The most common side effects of QULIPTA are nausea, constipation, and fatigue/sleepiness. These are not all the possible side effects of QULIPTA.

Doses- QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.

Please see full Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Migraine

• At AbbVie, we are committed to empowering people living with migraine disease. 
• We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. 
• Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments, and reduce the impact of migraine on their lives.

In the United States, AbbVie is the only company with three prescription treatments designed to meet patient needs across the spectrum of migraine to help patients living with this debilitating disease.

About AbbVie

• AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. 
• We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. 
• For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.

Forward-Looking Statements

• Some statements in the release are forward-looking, as defined by the Private Securities Litigation Reform Act of 1995.
• These statements often include words like ""believe,"" ""expect,"" ""anticipate,"" and ""project"", or use future/conditional verbs.
• Risks and uncertainties may cause actual results to differ materially, including:

-Intellectual property challenges
-Product competition
-R&D difficulties
-Litigation or government actions
-Regulatory changes
-Global macroeconomic factors (e.g., downturns, conflicts, trade disputes, tariffs)
-Other risks tied to global business operations

• Additional risk details are available in:
Item 1A, “Risk Factors,” of AbbVie’s 2024 Annual Report on Form 10-K.
Quarterly Reports on Form 10-Q.
Other filings with the U.S. Securities and Exchange Commission (SEC).

• AbbVie does not commit to updating these forward-looking statements unless legally required.

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