Findings from the first clinical trial program comparing the use of Teva’s Digihaler® System to standard of care in asthma management will be presented across six abstracts
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that new findings from the CONNECT clinical trial program assessing the use of the Digihaler System compared to standard of care (SoC) in asthma management will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2022 Annual Scientific meeting, being held November 10-14 in Louisville, Kentucky.
The data will be featured in six posters, three of which will highlight results from the CONNECT1 clinical trial evaluating the ProAir® Digihaler (albuterol sulfate) inhalation powder with a built-in electronic sensor in asthma management versus SoC. Three additional posters will share the first data from the CONNECT2 clinical trial assessing the joint use of the ProAir Digihaler and the AirDuo® Digihaler (fluticasone propionate and salmeterol) inhalation powder with a built-in sensor in asthma management versus SoC.
“We are looking forward to presenting six abstracts from our novel CONNECT clinical program assessing the use of the Digihaler System in asthma management and the potential impact of these digital health tools on patient-provider interactions, adherence over time, inhaler technique and frequency of SABA use,” said Randall Brown, MD MPH, Global Lead, Digital Health, Immunology and Respiratory Medical Affairs at Teva. “This is the first clinical trial program to evaluate the Digihaler System and its potential to support asthma management for patients with uncontrolled asthma compared to standard of care.”
The Digihaler is a digital health system comprised of an electronic multidose dry powder smart inhaler, connected app, Digital Health Platform cloud solution and dashboard that tracks reliever inhaler usage and inhalation quality as measured by inspiratory flow to aid in clinical decision-making. 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.
Initial findings from the CONNECT1 trial were recently presented at the European Respiratory Society (ERS) International Congress 2022, highlighting the impact of the ProAir Digihaler System on asthma management compared to standard of care (SoC), and the full CONNECT1 results were published in the Journal of Allergy and Clinical Immunology: In Practice following the ERS presentations.
The three CONNECT1 data sets that will be presented at ACAAI will highlight:
- The impact the ProAir Digihaler System had on average weekly and daily SABA use
- An exploratory assessment of use of the ProAir Digihaler System and inhaler technique maintained over 12 weeks
- Patients’ and clinical staff’s usability experience with the ProAir Digihaler System
The CONNECT2 trial was conducted to assess the role of both the ProAir and AirDuo Digihalers in the treatment of asthma. CONNECT2 was a 24-week open-label, multicenter, randomized, parallel group study that evaluated the ProAir Digihaler and AirDuo Digihaler and their impact on asthma management compared to SoC in 427 patients with asthma. Participants in the SoC group continued treatment with their current SoC asthma maintenance and reliever medications.
The three CONNECT2 data sets that will be presented at ACAAI explore:
- The impact of using the Digihaler System on asthma control
- The frequency and type of interactions between patients and physicians undertaken for asthma management prompted by the use of the Digihaler System
- How using the Digihaler System may impact adherence to maintenance treatment
These poster presentations can be accessed by registering for the meeting.
Teva-sponsored data to be presented includes:
#P097 Effectiveness Of A Maintenance and Reliever Digital System To Improve Asthma Control (CONNECT2)
Date/Time: Friday, November 11th, 3:45 PM – 4:00 PM
#P098 Data From A Maintenance And Reliever Digital System Support Patient–Clinician Interactions In Asthma (CONNECT2)
Date/Time: Friday, November 11th, 4:00 PM – 4:15 PM
#P100 Objective Measurement Of Adherence To Asthma Treatment With A Maintenance and Reliever Digital System (CONNECT2)
Date/Time: Friday, November 11th, 4:15 PM – 4:30 PM
#P096 Short-acting Beta2-agonist Use Reduction Among Patients With Uncontrolled Asthma Using A Reliever Digital System (CONNECT1)
Date/Time: Friday, November 11th, 4:30 PM – 4:45 PM
#P099 Inhaler Technique Maintenance In Patients With Uncontrolled Asthma Using A Reliever Digital System (CONNECT1)
Date/Time: Friday, November 11th, 4:45 PM – 5:00 PM
#P101 Usability Scores Of A Reliever Digital System In Patients With Uncontrolled Asthma (CONNECT1)
Date/Time: Friday, November 11th, 5:00 PM – 5:15 PM
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
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.
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.
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
- 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.
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:
- swelling of your face, mouth, and tongue
- breathing problems
Effects on heart
- increased blood pressure
- a fast or irregular heartbeat
- chest pain
Effects on nervous system
- 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)
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
- 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.
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 specialty 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 specialty 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 specialty products, 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; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; 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 Quarterly Report on Form 10-Q for the third quarter of 2022 and in our Annual Report on Form 10-K for the year ended December 31, 2021, 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.
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