June 15, 2020

AbbVie to Showcase 27 Studies at the Virtual 2020 Annual Scientific Meeting of the American Headache Society

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- Real-world studies assessed persistence of BOTOX® (onabotulinumtoxinA) versus calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs)
- Multiple studies assessed long-term safety and sustained efficacy of BOTOX® in clinical practice
- In addition to effectively treating migraine attacks when pain is moderate or severe, UBRELVY™ (ubrogepant) long-term trial data indicated that treating when pain is mild may significantly increase rates of pain freedom and absence of migraine-associated symptoms
- Preclinical data suggested that repeated treatment with UBRELVY™ is unlikely to produce the neural adaptations that underlie medication overuse headache (MOH)
- Key presentations highlight pivotal studies evaluating the safety, efficacy and tolerability of UBRELVY™, administered alone or with concomitant preventive medications
- Studies assessed the potential for pharmacokinetic (PK) drug-drug interactions (DDIs) between the investigational drug atogepant and other compounds, also evaluating PK, safety and tolerability profiles of atogepant

NORTH CHICAGO, Ill., June 15, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that it has 27 studies accepted to the virtual 2020 Annual Scientific Meeting of the American Headache Society (AHS). These abstracts highlight the company's ongoing innovation in migraine, including its investigational product, atogepant, while reinforcing the efficacy and safety profiles of BOTOX® and UBRELVY™.

"We are looking forward to highlighting the magnitude and breadth of our expanding migraine portfolio to help serve the needs of this underserved patient community," said Thomas J. Hudson, Senior Vice President, Research & Development and Chief Scientific Officer, AbbVie. "This leading research underscores our commitment to addressing the full spectrum of migraine with multiple treatment options and to making a meaningful difference in the lives of patients with this debilitating neurological disease. We are thankful the American Headache Society continues to recognize these significant scientific advancements."

BOTOX® is a mainstay preventive treatment for Chronic Migraine and will be featured in several presentations. BOTOX® has been approved for 30 years since its first FDA approval in 1989 for two rare muscle disorders – blepharospasm and strabismus in adults. The following 29-year retrospective analysis of BOTOX®-exposed mothers demonstrates the depth of understanding of use in clinical practice and will be featured as a podium presentation: 

  • Pregnancy Outcomes Following Exposure to OnabotulinumtoxinA Update: 29 Years of Safety Observation. Authors: Brin M, et al.

The following real-world studies evaluated treatment persistence in adults with migraine treated with OnabotulinumtoxinA and calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs). The studies were similar in design using claims and electronic health record databases. The studies demonstrated that significantly more patients starting OnabotulinumtoxinA were persistent with their treatment compared to those starting on CGRP mAbs for migraine. Future research is warranted to confirm these findings as more long-term data become available:

  • Real-World Persistence in Patients Treated with OnabotulinumtoxinA or Calcitonin Gene–Related Peptide Monoclonal Antibodies (CGRP mAbs) for Migraine: A Large US Administrative Claims Database Study. Authors: Ta J, et al.
  • Persistence to OnabotulinumtoxinA Versus Calcitonin Gene–Related Peptide Monoclonal Antibodies (CGRP mAbs) Among Migraine Patients in a US Electronic Health Record Database. Authors: Tung A, et al.

Results from several studies, including PREDICT, PREEMPT and COMPEL also add to the large body of evidence evaluating the long-term safety and sustained efficacy of BOTOX®. These studies assessed clinically relevant improvements among patients treated with BOTOX®, such as healthcare resource utilization, consecutive headache-free days, persistent response from treatment, headache severity, and health-related quality of life, among others.

UBRELVY™, approved in December of 2019, is a first-to-market, orally-administered CGRP receptor antagonist (or gepant) for the acute treatment of migraine. Key presentations will highlight pivotal studies evaluating the safety, efficacy and tolerability of UBRELVY™:

  • Pharmacokinetics, Safety, and Tolerability of Ubrogepant for the Acute Treatment of Migraine Following Coadministration with Preventive Monoclonal Antibody Treatment. Authors: Jakate A, et al.: This Phase I study demonstrated that UBRELVY™ appears safe and well-tolerated when co-administered with a monoclonal antibody CGRP targeted therapy in a population with migraine. There was no significant change in the pharmacokinetic (PK) profile of UBRELVY™ when co-administered with erenumab or galcanezumab, and there were no safety concerns identified.
  • Efficacy and Safety of Ubrogepant in Participants Taking Concomitant Preventive Medication. Authors: Blumenfeld A, et al.: An analysis of 2246 participants from the ACHIEVE trials demonstrated that concomitant preventive medication use did not impact the efficacy of UBRELVY™ for the acute treatment of migraine, and no safety signal was identified with concomitant use.
  • Ubrogepant is Effective in the Acute Treatment of Migraine with Mild Pain. Authors: Lipton R, et al.: In addition to effectively treating migraine attacks when pain is moderate or severe, UBRELVY™ long-term trial data indicated that treating when pain is mild may significantly improve rates of pain freedom and absence of migraine-associated symptoms.
  • Ubrogepant Does Not Induce Latent Sensitization in a Preclinical Model of Medication Overuse Headache. Authors: Navratilova E, et al.: Preclinical data suggested that repeated treatment with UBRELVY™ is unlikely to produce the neural adaptations that underlie medication overuse headache (MOH).

AbbVie continues to advance its migraine program with atogepant, an investigational small molecule oral CGRP receptor antagonist (or gepant) currently in Phase 3 development specifically designed for the prevention of migraine. Key studies presented during this Congress evaluated the PK, safety and tolerability profiles of the investigational drug in addition to the potential for PK drug-drug interactions (DDIs) between atogepant and other compounds.

Following is the full list of accepted abstracts based on treatment and category, which is also accessible HERE. 

BOTOX® (onabotulinumtoxinA)

  • Pregnancy Outcomes Following Exposure to OnabotulinumtoxinA Update: 29 Years of Safety Observation. Authors: Brin M, et al.
  • Responder Rates to OnabotulinumtoxinA in Patients with Chronic Migraine: A Post Hoc Analysis of the COMPEL Study. Authors: Rothrock J, et al.
  • Benefits of Long-Term OnabotulinumtoxinA Treatment in Chronic Migraine: Results from the COMPEL Study. Authors: Blumenfeld A, et al.
  • Real-World Persistence in Patients Treated with OnabotulinumtoxinA or Calcitonin Gene–Related Peptide Monoclonal Antibodies (CGRP mAbs) for Migraine: A Large US Administrative Claims Database Study. Authors: Ta J, et al.
  • Persistence to OnabotulinumtoxinA Versus Calcitonin Gene–Related Peptide Monoclonal Antibodies (CGRP mAbs) Among Migraine Patients in a US Electronic Health Record Database. Authors: Tung A, et al.
  • Healthcare Resource Utilization and Health-Related Quality of Life in Adult Patients with Chronic Migraine: Results from the PREDICT Study. Authors: Boudreau G, et al.
  • OnabotulinumtoxinA Treatment Improved Health-Related Quality of Life in Adults with Chronic Migraine: Results from a Prospective, Observational Study (PREDICT). Authors: Boudreau G, et al.
  • Sustained Benefits of OnabotulinumtoxinA Treatment in Chronic Migraine: Results from a PREEMPT Pooled Analysis. Authors: Silberstein S, et al.
  • Consecutive Headache-Free Days After Long-term Treatment with OnabotulinumtoxinA in Patients with Chronic Migraine: A Post Hoc Analysis of the Pooled PREEMPT Studies. Authors: Diener H, et al.
  • Sustained Clinical Benefits Following OnabotulinumtoxinA Treatment in Patients with Chronic Migraine: A Post Hoc Analysis of the Pooled PREEMPT Studies. Authors: Dodick D, et al.

UBRELVY™ (ubrogepant)

  • Ubrogepant Does Not Induce Latent Sensitization in a Preclinical Model of Medication Overuse Headache. Authors: Navratilova E, et al.
  • Efficacy and Safety of Ubrogepant in Participants Taking Concomitant Preventive Medication. Authors: Blumenfeld A, et al.
  • Pharmacokinetics, Safety, and Tolerability of Ubrogepant for the Acute Treatment of Migraine Following Coadministration with Preventive Monoclonal Antibody Treatment. Authors: Jakate A, et al.
  • Ubrogepant is Effective in the Acute Treatment of Migraine with Mild Pain. Authors: Lipton R, et al.
  • Safety and Tolerability of Ubrogepant within Various Demographic and Clinical Characteristic Subgroups. Authors: Ailani J, et al.
  • Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy from ACHIEVE I and ACHIEVE II Phase 3 Trials. Authors: Hutchinson S, et al.
  • Improved Functionality, Satisfaction, and Global Impression of Change with Ubrogepant for the Acute Treatment of Migraine in Triptan Insufficient Responders. Authors: Lipton R, et al.

Atogepant

  • Single Therapeutic Doses of Atogepant Are Not Associated with a Clinically Relevant Drug-Drug Interaction When Coadministered with Acetaminophen or Naproxen. Authors: Boinpally R, et al.
  • Pharmacokinetics and Safety of Single-Dose Atogepant in Participants with Hepatic Impairment. Authors: Boinpally R, et al.
  • Multiple, Once-Daily, Oral Doses of 170 mg Atogepant for 28 Days Are Safe and Well Tolerated with No Clinically Significant Effect on Alanine Aminotransferase in Healthy Adults. Authors: Min K, et al.
  • Coadministration of Single Therapeutic Oral Doses of Atogepant and Sumatriptan Produces No Clinically Relevant Drug-Drug Interactions. Authors: Boinpally R, et al.
  • A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults. Authors: Boinpally R, et al.

Migraine

  • Assessing Barriers to Care in Episodic and Chronic Migraine: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Buse D, et al.
  • Gastrointestinal Comorbidities Representing a Relative Contraindication to NSAID Use: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Buse D, et al.
  • Acute Treatment Management Gaps in People with Migraine: Results of the CaMEO Study. Authors: Buse D, et al.
  • Operationalization of Triptan Labels to Identify Migraine Patients with Cardiovascular Contraindications and Warnings Using Real-world Claims Data. Authors: Dodick D, et al.
  • Exploring the Boundaries Between Episodic and Chronic Migraine: Results from the CaMEO Study. Authors: Lipton R, et al.

BOTOX® Indications 

 BOTOX® is a prescription medicine that is injected into muscles and used:

  • To prevent headaches in adults with Chronic Migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
  • To treat certain types of eye muscle problems (Strabismus) or abnormal spasm of the eyelids (Blepharospasm) in people 12 years and older

It is not known whether BOTOX® is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

 It is not known whether BOTOX® is safe or effective for other types of muscle spasms.

IMPORTANT SAFETY INFORMATION

BOTOX® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine, blepharospasm, or strabismus.

BOTOX® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX®. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Do not receive BOTOX® if you: are allergic to any of its ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

The dose of BOTOX® is not the same as, or comparable to, any other botulinum toxin product.

Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX® should be discontinued.

Tell your doctor about all your muscle or nerve conditions such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX®.

Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX® for their blepharospasm, especially in people with certain nerve disorders. BOTOX® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.

Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX® for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX®.

Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX® include: dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; drooping eyebrows.

For more information refer to the Medication Guide or talk with your doctor.

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.

Please see BOTOX® full Product Information, including Boxed Warning and Medication Guide.

UBRELVY™ Indication
UBRELVYTM (ubrogepant) is indicated for the acute treatment of migraine with or without aura in adults. UBRELVY is not indicated for the preventive treatment of migraine.

IMPORTANT SAFETY INFORMATION 
Contraindication: Concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin). 
Adverse Reactions: The most common adverse reactions were nausea (4%) and somnolence (3%).

Please see link to full Prescribing Information.

About Atogepant
Atogepant is an orally-administered, CGRP receptor antagonist specifically in development for the preventive treatment of migraine. With multiple dose strengths, dosing flexibility, and rapid onset without titration, atogepant is an ideal candidate for preventive treatment. 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 and selective CGRP receptor antagonists confer clinical benefit in migraine.

About AbbVie
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, FacebookLinkedIn or Instagram.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

SOURCE AbbVie

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Julie.Ciardiello@allergan.com or Heather Katt
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Investors
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