TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE)--Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that new data on its Digihaler System will be presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2023 Annual Meeting, being held February 24-27 in San Antonio, Texas. The data includes findings from the CONNECT2 clinical trial program as well as information on patients and healthcare professionals' real-world use of the smart inhaler system. The Digihaler System is the first and only smart inhaler system with built-in sensors that provide objective inhaler event data to help patients and their doctors support asthma management and develop personalized treatment plans.
The data will be featured in five posters, which will highlight:
- Real-world Digihaler System usage patterns for patients
- The relationship between medication adherence and patients’ voluntary responses to a daily self-assessment (DSA) feature
- Barriers, facilitators, and HCP recommendations related to implementation of digital inhaler technology
“The data we are presenting at AAAAI share meaningful insights for doctors and asthma patients about asthma management based on information provided by the Digihaler System,” said Tanisha Hill, Senior Medical Director, Respiratory and Digital Health Medical Lead at Teva. “Understanding trends around adherence and predictors of success in disease management are important to informing more personalized treatment.”
Digihaler is a digital health system comprised of an electronic multi-dose dry powder smart inhaler, connected app, Digital Health Platform cloud solution and dashboard. Digihaler inhalers have built-in flow sensors that detect, record and store objective data showing how often and how well patients use their inhalers, as measured by inspiratory flow. Patients are able to view their data on the Digihaler app, including inhaler use patterns over time, and can share it with a healthcare provider to facilitate dialogue and personalize treatment discussions. Healthcare providers can also monitor the data on a dashboard with patient permission.
As per the U.S. Food and Drug Administration (FDA) approved label, there is no evidence that the use of the app leads to improved clinical outcomes, including safety and efficacy.
CONNECT2
The CONNECT clinical program evaluated the potential impact of Digihaler System on patient-provider interactions, adherence over time, inhaler technique and frequency of short-acting beta agonist (SABA) use. The CONNECT2 trial was conducted to assess the role of both the ProAir® Digihaler (albuterol sulfate) inhalation powder and AirDuo® Digihaler (fluticasone propionate and salmeterol) inhalation powder in the treatment of asthma as part of the Digihaler System.
CONNECT2 was a 24-week open-label, multicenter, randomized, parallel group study that evaluated the impact of this Digihaler System on asthma management compared to standard of care (SoC) in 427 patients with asthma. Participants in the SoC group continued treatment with their current SoC asthma maintenance and reliever medications.
Digihaler integrated inhalers transmit data wirelessly to a smartphone application (App), which allows for inhaler event tracking. The App includes a voluntary, non-respiratory-specific DSA. The DSA includes questions asking how a patient is feeling on a three-point scale ranging from sad to neutral to happy.
The two CONNECT2 analyses that will be presented at AAAAI explore:
- The relationship between SABA use and patient self-assessment responses
- The relationship between medication adherence and patient self-assessment responses
Real-World Digital Health Platform Analysis
The Digihaler Digital Health Platform allows patients to track their inhaler events, and inhaler use, which is recorded as an event when the cap is opened or a patient inhales. The objective data is collected in the App and can be shared with physicians to help them make more informed treatment decisions.
The poster that will be presented at AAAAI explores:
- Real-world usage patterns and data from a digital health platform
Implementation Study
The study was comprised of telephone interviews and web surveys with specialists who prescribed the digital inhaler to at least one of their patients with asthma or chronic obstructive pulmonary disease (COPD). The surveys and semi-structured interviews were used to evaluate barriers and facilitators to implementation from participants. Investigators utilized the consolidated framework for implementation research (CFIR) theoretical framework to better understand how the Digihaler System was used in clinical practice and report recommendations from early adopters of the technology.
The two implementation research posters that will be presented at AAAAI explore:
- Theory-based implementation research to evaluate barriers and facilitators to the implementation of digital inhaler technology in clinical practice
- The real-world implementation of digital inhaler technology in clinical practice
These poster presentations can be accessed by registering for the meeting.
Teva-sponsored data to be presented includes:
#P37 Real-World Inhaler Usage Patterns Obtained from a Digital Health Platform
Session: Poster Presentations and Case Study Posters
Date/Time: Friday, February 24th, 3:15 PM – 4:15 PM
#P487 Relationship Between SABA Use and Self-Assessment Responses in Patients with Asthma
Session: Poster Presentations and Case Study Posters
Date/Time: Sunday, February 26th, 9:45 AM – 10:45 AM
#P488 Relationship Between Medication Adherence and Self-Assessment Responses in Patients with Asthma
Session: Poster Presentations and Case Study Posters
Date/Time: Sunday, February 26th, 9:45 AM – 10:45 AM
#P504 Use of Theory-Based Implementation Research to Evaluate Barriers and Facilitators to Implementation of a Novel Digital Inhaler Technology in Clinical Practice
Session: Poster Presentations and Case Study Posters
Date/Time: Sunday, February 26th, 9:45 AM – 10:45 AM
#P511 Implementation of a Novel Digital Inhaler Technology in Real-World Clinical Practice: Experiences and Recommendations from Early Adopters
Session: Poster Presentations and Case Study Posters
Date/Time: Sunday, February 26th, 9:45 AM – 10:45 AM
ProAir Digihaler Indications and Usage
ProAir Digihaler (albuterol sulfate) Inhalation Powder is a prescription medicine used in people ≥4 years of age for the treatment or prevention of bronchospasm in people who have reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
Important Safety Information About ProAir Digihaler
- Contraindications: ProAir Digihaler (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose
- Paradoxical Bronchospasm: ProAir Digihaler can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir Digihaler and institute alternative therapy if paradoxical bronchospasm occurs
- Deterioration of Asthma: Need for more doses of ProAir Digihaler than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment, such as possible need for anti-inflammatory treatment, e.g., corticosteroids
- Use of Anti-Inflammatory Agents: ProAir Digihaler alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids
- Cardiovascular Effects: ProAir Digihaler, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued. ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
- Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma
- Hypersensitivity Reactions including Anaphylaxis: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of therapies containing lactose, an inactive ingredient in ProAir Digihaler
- Coexisting Conditions: ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines
- Hypokalemia: As with other beta-agonists, ProAir Digihaler may produce significant hypokalemia in some patients. The decrease is usually transient, not requiring supplementation
- Most common adverse reactions (≥1% and >placebo) are back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis, oropharyngeal pain and vomiting
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Drug Interactions: Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler
- Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers
- Diuretics: Caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics (such as loop or thiazide diuretics). Consider monitoring potassium levels
- Digoxin: Carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and ProAir Digihaler
- Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: ProAir Digihaler should be administered with extreme caution to patients being treated with these agents, or within 2 weeks of discontinuation of these agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy
Please read the full Prescribing Information.
AirDuo Digihaler Indications and Usage
- AirDuo Digihaler is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older.
- AirDuo Digihaler is not used to relieve sudden breathing problems from asthma and won't replace a rescue inhaler.
AirDuo Digihaler contains a built-in electronic module that records and stores information about inhaler events. AirDuo Digihaler may be used with, and transmits information to, a mobile App.
AirDuo Digihaler does not need to be connected to the app in order for you to take your medicine.
Important Safety Information About AirDuo Digihaler
- AirDuo Digihaler contains salmeterol. Long-acting beta2-agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AirDuo Digihaler contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
- Do not use AirDuo Digihaler to treat sudden breathing problems from asthma. Always have a rescue inhaler with you to treat sudden symptoms.
- Do not use AirDuo Digihaler if you have a severe allergy to milk proteins or if you are allergic to any of the ingredients in the product. Ask your healthcare provider if you are not sure.
- Do not use AirDuo Digihaler more often than prescribed.
- Do not take AirDuo Digihaler with other medicines that contain a LABA for any reason.
- Tell your healthcare provider about all the medicines you take and about all of your health conditions.
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AirDuo Digihaler can cause serious side effects, including:
- Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using AirDuo Digihaler to help reduce your chance of getting thrush.
- Weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur.
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Reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as AirDuo Digihaler). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
- feeling tired
- lack of energy
- weakness
- nausea and vomiting
- low blood pressure
- Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using AirDuo Digihaler and call your healthcare provider right away.
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Serious allergic reactions. Stop using AirDuo Digihaler and call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
- rash
- hives
- swelling of your face, mouth, and tongue
- breathing problems
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Effects on heart
- increased blood pressure
- a fast or irregular heartbeat
- chest pain
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Effects on nervous system
- tremor
- nervousness
- Bone thinning or weakness (osteoporosis)
- Slowed growth in children. A child's growth should be checked often.
- Eye problems including glaucoma and cataracts. You should have regular eye exams while using AirDuo Digihaler.
- Changes in laboratory blood values (sugar, potassium, certain types of white blood cells)
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Common side effects of AirDuo Digihaler include:
- Infection of nose and throat (nasopharyngitis)
- thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
- back pain
- headache
- cough
- These are not all the possible side effects of AirDuo Digihaler. Call your healthcare provider for medical advice about side effects.
- 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 full Prescribing Information for AirDuo Digihaler.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative and biopharmaceutical products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of our digihaler products family, including ProAir Digihaler and AirDuo Digihaler; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our innovative medicines, including AUSTEDO®, AJOVY® and COPAXONE®, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
