A clinical trial of STN1014100 ophthalmic solution in healthy adult male volunteers and dry eye patients for single and repeated dose - Phase I/IIa, clinical pharmacology study, exploratory study -

Start Date20 Jan 2023

Sponsor / Collaborator-

JPRN-jRCTs032210543 / RecruitingNot ApplicableIIT

Examination of the usefulness of a dynamic flat-panel detector system for patients with chronic pulmonary obstructive disease under the treatment with Tiotropium/Olodaterol

Start Date26 Aug 2022

Sponsor / Collaborator-

NCT05927155 / CompletedPhase 3IIT

Comparison of Bronchodilation and Oxygenation Patterns Induced by Long-acting β2-agonists and Muscarinic Antagonists in Chronic Obstructive Pulmonary Disease (COPD)

The goal of this clinical trial was to compare the action of long-acting ß2-agonists (LABA-olodaterol) and muscarinic antagonists (LAMA-tiotropium) on tissue oxygenation in COPD considering their impact on proximal and peripheral ventilation and, eventually, on lung capillary volume. The hypothesis was that LABA would have a more peripheral effect than LAMA (due to the opposite gradient of their receptors) and better peripheral ventilation would result in a greater oxygenation.
Before and after LABA (visit 1) and LAMA (visit 2) inhalation, COPD participants were asked to perform single-breath washout and forced oscillation tests, double diffusion technique and spirometry, while transcutaneous oxygenation was continuously recorded.

Start Date15 Jun 2021

Sponsor / Collaborator

Hôpital Erasme

100 Clinical Results associated with Olodaterol Hydrochloride

100 Translational Medicine associated with Olodaterol Hydrochloride

100 Patents (Medical) associated with Olodaterol Hydrochloride

247

Literatures (Medical) associated with Olodaterol Hydrochloride

08 Aug 2024·Expert review of pharmacoeconomics & outcomes research

Improved medication adherence in COPD patients using tiotropium or tiotropium olodaterol with the HealthPrize digital behavior change program

Article

Author: DeKoven, Mitchell ; Firlik, Katrina S ; Shaikh, Asif ; Anupindi, Vamshi Ruthwik ; Hayes, Vincent ; Franchino-Elder, Jessica

OBJECTIVE:

To assess the impact of the HealthPrize RespiPoints™ program on treatment adherence and persistence in adults with chronic obstructive pulmonary disease (COPD).

METHODS:

In this retrospective cohort study, program participants and nonparticipants receiving tiotropium bromide (TIO) or TIO and olodaterol between 1 January 2015-31 March 2020 were propensity score matched (PSM), from the linked database of the HealthPrize patient list and IQVIA PharMetrics® Plus. Treatment adherence, persistence, healthcare resource utilization, and costs were compared. Multivariable logistic regression models assessed the odds of adherence (≥80% proportion of days covered [PDC]), adjusted risk of discontinuation, and adjusted total healthcare costs.

RESULTS:

Program participants (n = 262) demonstrated a 44% greater adherence during followup than nonparticipants (n = 262) (mean [standard deviation] PDC: 0.72 [0.27] vs 0.50 [0.36], p < 0.0001). Participants had higher odds of adherence vs nonparticipants (adjusted odds ratio: 2.51; 95% confidence interval: 1.72-3.66, p < 0.0001) and a lower percentage of participants discontinued their index medication (19.85% vs 33.59%, p = 0.0004). Fewer participants were hospitalized during follow-up (13.74% vs 17.56%, p = 0.23); adjusted total medical costs were 24% lower (p = 0.08). Higher pharmacy costs partially offset lower healthcare costs.

CONCLUSIONS:

Program participants showed improved COPD medication adherence and persistence compared to nonparticipants.

01 Aug 2024·CHIRALITY

The Development of One New Normal Phase Liquid Chromatography Method and Thermodynamic Investigation of Olodaterol Hydrochloride Enantiomer

Article

Author: Wang, Zhongqing ; Qiu, Meiyan ; Luan, Baolei ; Rao, Wanbing ; Cai, Shaoyu ; Zhang, Chenxia

ABSTRACT:

In order to improve and replace the enantiomer method outlined in the olodaterol hydrochloride draft monograph (From the European Pharmacopoeia forum), one new, simple, and fast enantioselective normal phase high‐performance liquid chromatography chiral method was developed on polysaccharide‐based Chiral MX (2) (4.6 × 250 mm, 5 μm) column. n‐Hexane, ethanol, and diethylamine in the ratio of 40:60:0.1 (V/V/V) were selected as mobile phase at a flow rate of 0.8 mL/min, and the detection was performed on a photodiode array detector at 225 nm with 5 μL injection volume. The column temperature was set at 40°C for better peak shape and sensitivity. The analysis time can be shortened to 15 min, whereas the resolution between enantiomer and olodaterol was found to be even more than 10.0, which was far better than that obtained with the reported method in this draft monograph. The developed chiral method was validated in accordance with ICH Q2 (R1), including specificity, LOD&LOQ, precision, linearity, accuracy, and robustness. Thereby, the proposed method was demonstrated to be suitable for the determination of enantiomer in olodaterol hydrochloride bulk drug and drug product. Besides, the thermodynamic parameters were evaluated on the basis of Van't Hoff plots that was used to explain correlative chiral recognition mechanisms with the chiral stationary phase.

01 Aug 2024·BMJ Open Respiratory Research

Dynamic chest radiographic evaluation of the effects of tiotropium/olodaterol combination therapy in chronic obstructive pulmonary disease: the EMBODY study protocol for an open-label, prospective, single-centre, non-controlled, comparative study

Article

Author: Kamata, Tomoko ; Matsushita, Kazuyuki ; Fujii, Shota ; Urano, Akira ; Yokota, Hajime ; Kawata, Naoko ; Uno, Takashi ; Katsumata, Megumi ; Ono, Kojiro ; Suzuki, Yuri ; Suzuki, Eiko ; Ota, Joji ; Okumura, Kenichiro ; Masuda, Yoshitada ; Ozawa, Yoshihito ; Nishiyama, Akira ; Abe, Eriko ; Sakao, Seiichiro ; Imamoto, Takuro ; Suzuki, Takuji ; Tatsumi, Koichiro ; Okamoto, Kentaro ; Ikari, Jun

Introduction:

To date, there is limited evidence on the effects of bronchodilators on respiratory dynamics in chronic obstructive pulmonary disease (COPD). Dynamic chest radiography (DCR) is a novel radiographic modality that provides real-time, objective and quantifiable kinetic data, including changes in the lung area (Rs), tracheal diameter, diaphragmatic kinetics and pulmonary ventilation during respiration, at a lower radiation dose than that used by fluoroscopic or CT imaging. However, the therapeutic effect of dual bronchodilators on respiratory kinetics, such as chest wall dynamics and respiratory muscle function, has not yet been prospectively evaluated using DCR.

Aim:

This study aims to evaluate the effects of bronchodilator therapy on respiratory kinetics in patients with COPD using DCR.

Methods and analysis:

This is an open-label, prospective, single-centre, non-controlled, comparative study. A total of 35 patients with COPD, aged 40–85 years, with a forced expiratory volume in the first second of 30–80%, will be enrolled. After a 2–4 weeks washout period, patients will receive tiotropium/olodaterol therapy for 6 weeks. Treatment effects will be evaluated based on DCR findings, pulmonary function test results and patient-related outcomes obtained before and after treatment. The primary endpoint is the change in Rs after therapy. The secondary endpoints include differences in other DCR parameters (diaphragmatic kinetics, tracheal diameter change and maximum pixel value change rate), pulmonary function test results and patient-related outcomes between pre-therapy and post-therapy values. All adverse events will be reported.

Ethics and dissemination:

Ethical approval for this study was obtained from the Ethics Committee of Chiba University Hospital. The results of this trial will be published in a peer-reviewed journal.

Trial registration number:

jRCTs032210543.

News (Medical) associated with Olodaterol Hydrochloride

01 Jun 2024

·www.prnewswire.com

Boehringer Ingelheim's COPD and asthma inhalers are now available for $35 a month for eligible patients

Boehringer's first-of-its-kind program automatically reduces the costs of its COPD and asthma inhalers at the pharmacy counter for vast majority of eligible patients Program provides predictable, affordable and consistent costs for as many patients as possible, including uninsured patients and those with high co-pays RIDGEFIELD, Conn., June 1, 2024 /PRNewswire/ -- Boehringer Ingelheim's new program to cap out-of-pocket costs at $35 per month for eligible patientsi for the company's inhalers is now available. With this program, patients who have had difficulty navigating the current healthcare system will now be able to afford the Boehringer inhalers they need. "Ensuring equitable access to life-saving medications is not just a commitment—it's our responsibility," said Jean-Michel Boers, President and CEO, Boehringer Ingelheim USA Corporation. "This program and its $35 cost to patients applies to our entire portfolio of inhalers, making them affordable to all eligible patients, including the most vulnerable patients, such as those who are uninsured or underinsured. While we recognize this is just one solution, we see it as a stepping-stone in our ongoing commitment to ensure the healthcare system is fairer and simpler for all patients." Starting today, the reduced out-of-pocket cost will be automatically applied at participating retail pharmacies for eligible patients with commercial insurance. More than 90% of pharmacies across the country are participating in the program, making the change seamless and automatic for most patients. There are no forms to fill out or websites to go to—the discount happens electronically with no action required. All other eligible patients, including those whose pharmacies do not participate and those without insurance, can visit to enroll for a savings card to present at pharmacies to receive the same $35 cap of out-of-pocket costs. The program applies to all Boehringer Ingelheim inhalers, including: Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol Combivent® Respimat® (ipratropium bromide and albuterol) Inhalation Spray Spiriva® HandiHaler® (tiotropium bromide inhalation powder) Spiriva® Respimat® 1.25 mcg (tiotropium bromide) Inhalation Spray Spiriva® Respimat® 2.5 mcg (tiotropium bromide) Inhalation Spray Stiolto® Respimat® (tiotropium bromide and olodaterol) Inhalation Spray Striverdi® Respimat® (olodaterol) Inhalation Spray The program builds on Boehringer's long-standing commitment to supporting patients. The company provides savings cards for most of its products, which help patients meet the co-payments required by their insurance companies. In addition, the company provides medicine for free to eligible patients through the Boehringer Cares Foundation. About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at . iTerms and conditions apply. Government restrictions exclude people enrolled in federal government insurance programs from co-pay support. ATROVENT HFA (ipratropium bromide HFA) INHALATION AEROSOL Indication for Use ATROVENT HFA (ipratropium bromide HFA) Inhalation Aerosol is a prescription maintenance treatment for bronchospasm (airway narrowing) in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Important Safety Information Do not use ATROVENT HFA if you are allergic to ipratropium or any of the ingredients in ATROVENT HFA or to atropine or similar drugs. ATROVENT HFA is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems. Allergic reactions may occur, including itching, swelling of the face, lips, tongue, or throat (involving difficulty in breathing or swallowing), rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Some of these may be serious. If you experience any of these symptoms, stop taking ATROVENT HFA at once and call your doctor or get emergency help. ATROVENT HFA can cause the narrowing of the airways to get worse (paradoxical bronchospasm) which may be life threatening. If this happens, stop taking ATROVENT HFA at once and call your doctor or get emergency help. ATROVENT HFA may increase eye pressure which may cause or worsen some types of glaucoma. Do not get the spray into your eyes. The spray may cause eye pain or discomfort, blurred vision, enlarged pupils, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking ATROVENT HFA and call your doctor right away. Dizziness and blurred vision may occur with ATROVENT HFA. Should you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or machinery. ATROVENT HFA may cause difficulty with urination. Symptoms may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking ATROVENT HFA and call your doctor right away. The most common side effects reported with use of ATROVENT HFA were bronchitis, COPD flare-up (exacerbation), shortness of breath and headache. Tell your doctor about all medicines you are taking, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with ATROVENT HFA can increase side effects. Please see full Prescribing Information including Instructions for Use. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1‑800‑FDA‑1088. (9/16) CL-AT-0017 Combivent Respimat (ipratropium bromide and albuterol) Inhalation Spray Indication for Use COMBIVENT RESPIMAT (ipratropium bromide and albuterol) is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm (airway narrowing) and who require a second bronchodilator. Important Safety Information Do not use COMBIVENT RESPIMAT if you are allergic to any of the ingredients in COMBIVENT RESPIMAT or to atropine or other similar drugs. COMBIVENT RESPIMAT can cause the narrowing of the airways to get worse (paradoxical bronchospasm) which may be life threatening. If this happens, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help. COMBIVENT RESPIMAT can cause serious heart-related side effects, such as palpitations, chest pain, rapid heart rate, high blood pressure, tremor, or nervousness. Call your doctor if you experience any of these symptoms. Avoid spraying COMBIVENT RESPIMAT into your eyes. COMBIVENT RESPIMAT may increase eye pressure which may cause or worsen some types of glaucoma. If you have sudden vision changes, eye pain or visual halos, stop taking COMBIVENT RESPIMAT and call your doctor right away. COMBIVENT RESPIMAT may cause difficulty with urination. Dizziness and blurred vision may occur with COMBIVENT RESPIMAT. Should you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or other machines. Do not use COMBIVENT RESPIMAT more often than your doctor has directed. Deaths have been reported with similar inhaled medicines in asthma patients who use the medicine too much. Seek medical attention if your treatment with COMBIVENT RESPIMAT becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual. Allergic reactions may occur, including itching, swelling of the face, lips, tongue, or throat (involving difficulty in breathing or swallowing), rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Some of these may be serious. If you experience any of these symptoms, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help. Tell your doctor about all your medical conditions, especially if you have narrow-angle glaucoma, prostate or urinary problems, a history of heart conditions (such as irregular heartbeat, high blood pressure), thyroid disorder, or diabetes. Also tell your doctor if you are pregnant or nursing. Tell your doctor about all medicines you are taking, especially heart medications or drugs to treat depression. The most common side effects reported with use of COMBIVENT RESPIMAT include infection of the ears, nose, and throat, runny nose, cough, bronchitis, headache, and shortness of breath. Click here for full Prescribing Information and Patient Instructions for Use. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. CL-CBR-100003 10.31.2018 SPIRIVA RESPIMAT (tiotropium bromide) Inhalation Spray and SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) Indications SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HANDIHALER are long-term, once-daily, prescription maintenance medicines used to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis and emphysema. SPIRIVA RESPIMAT and SPIRIVA HANDIHALER also reduce the likelihood of flare-ups (COPD exacerbations). SPIRIVA RESPIMAT, 1.25 mcg, is a long-term, once-daily, prescription maintenance treatment of asthma for people 6 years and older. SPIRIVA is not a treatment for sudden symptoms of asthma or COPD. Important Safety Information for SPIRIVA RESPIMAT Do not use SPIRIVA RESPIMAT or SPIRIVA HANDIHALER if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in these medicines. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER are not rescue medicines and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue, or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and seek emergency medical care. Before using SPIRIVA HANDIHALER, tell your doctor if you have a severe allergy to milk proteins. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause your breathing to suddenly get worse (bronchospasm). If this happens, use your rescue inhaler, stop taking SPIRIVA, and call your doctor right away or seek emergency medical care. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can increase the pressure in your eyes (acute narrow-angle glaucoma) which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away. Dizziness and blurred vision may occur with SPIRIVA RESPIMAT or SPIRIVA HANDIHALER. If you experience these symptoms, use caution when engaging in activities such as driving a car, or operating appliances or machinery. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away. The most common side effects reported with SPIRIVA RESPIMAT in patients with COPD include sore throat, cough, dry mouth, and sinus infection. The most common side effects with SPIRIVA RESPIMAT in adult patients with asthma were sore throat, headache, bronchitis, and sinus infection. The side effect profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma. The most common side effects reported with SPIRIVA HANDIHALER in patients with COPD include upper respiratory tract infection, dry mouth, sinus infection, sore throat, non-specific chest pain, urinary tract infection, indigestion, runny nose, constipation, increased heart rate, and blurred vision. Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through your mouth using the HANDIHALER device. Do not spray SPIRIVA RESPIMAT into your eyes, as this may cause blurring of vision and pupil dilation. Tell your doctor about all your medical conditions including kidney problems, glaucoma, enlarged prostate, problems passing urine, or blockage in your bladder. Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with SPIRIVA can increase side effects. Do not use SPIRIVA RESPIMAT and SPIRIVA HANDIHALER together. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Click here for full Prescribing Information and Patient Instructions for Use for SPIRIVA RESPIMAT. Click here for full Prescribing Information and Patient Instructions for Use for SPIRIVA HANDIHALER. CL-SVR-0048 2.15.2017 STIOLTO RESPIMAT (tiotropium bromide and olodaterol) Inhalation Spray APPROVED USE FOR STIOLTO RESPIMAT STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, 2 puffs 1 time each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. STIOLTO is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. STIOLTO is not for asthma. Important Safety Information for STIOLTO RESPIMAT Do not use STIOLTO if you have asthma. People with asthma who take long-acting beta2-agonist (LABA) medicines, such as olodaterol, (one of the medicines in STIOLTO), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death. Do not use STIOLTO if you are allergic to tiotropium, ipratropium, atropine or similar drugs, olodaterol, or any ingredient in STIOLTO. Call your healthcare provider or get emergency medical care if you experience symptoms of a serious allergic reaction including: rash, hives, itching, swelling of the face, lips, tongue, throat, and difficulties in breathing or swallowing. Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STIOLTO. Do not use STIOLTO more often than prescribed by your doctor. Do not use STIOLTO with other LABAs or anticholinergics. Do not use STIOLTO for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. Tell your doctor about all your medical conditions including heart problems, high blood pressure, seizures, thyroid problems, diabetes, kidney problems, glaucoma, enlarged prostate, and problems passing urine. STIOLTO can cause serious side effects, including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, tremor, headache, nervousness, high blood sugar, or low blood potassium that may cause muscle weakness or abnormal heart rhythm. If any of these happens, stop taking STIOLTO and seek immediate medical help. STIOLTO can cause new or worsening eye problems including narrow-angle glaucoma, and can increase the pressure in your eyes, which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking STIOLTO and call your doctor right away. STIOLTO can cause new or worsened urinary retention. Symptoms of urinary retention may include difficulty passing urine, painful urination, urinating frequently, or urinating in a weak stream or drips. If you have any of these symptoms, stop taking STIOLTO and call your doctor right away. The most common side effects of STIOLTO are runny nose, cough, and back pain. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, eye drops, vitamins, and herbal supplements. STIOLTO and certain other medicines may affect each other. STIOLTO is for oral inhalation only. The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler. Do not spray STIOLTO into your eyes. Your vision may become blurred and your pupils may become larger (dilated). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Read the step-by-step patient Instructions for Use for STIOLTO RESPIMAT before you use your inhaler. Please see accompanying full Prescribing Information, Patient Information, and Instructions for Use for STIOLTO RESPIMAT. CL-STO-100022 6.5.2019 STRIVERDI® RESPIMAT® (olodaterol) Inhalation Spray APPROVED USE for STRIVERDI RESPIMAT Striverdi® Respimat® (olodaterol) Inhalation Spray is a prescription medicine used long term, 2 puffs, 1 time each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. STRIVERDI RESPIMAT is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. Striverdi is not for asthma. Important Safety Information for STRIVERDI RESPIMAT Do not use STRIVERDI if you have asthma. People with asthma who take long‐acting beta2‐agonist (LABA) medicines, such as STRIVERDI RESPIMAT, without also using a medicine called an inhaled corticosteroid (ICS), have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death. Get emergency medical care if your breathing problems worsen quickly or you use your rescue medicine but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STRIVERDI. Do not use STRIVERDI RESPIMAT more often than prescribed for you by your doctor. Do not use STRIVERDI RESPIMAT with other LABAs. Do not use STRIVERDI for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. Tell your doctor about all of your medical conditions, including heart problems, high blood pressure, seizures, thyroid problems, and diabetes. STRIVERDI RESPIMAT can cause serious side effects including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, tremor, headache, nervousness, high blood sugar, or low blood potassium that may cause muscle weakness or abnormal heart rhythm. If any of these happen, stop taking STRIVERDI and seek immediate medical help. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction including: rash, hives, itching, swelling of the face, lips, tongue, throat, and difficulties in breathing or swallowing. The most common side effects are runny nose, sore throat, upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain, and joint pain. Tell your doctor about all the medicines you take, including prescription and non‐prescription medicines, vitamins, and herbal supplements. STRIVERDI and certain other medicines may affect each other. STRIVERDI is for oral inhalation only. The STRIVERDI cartridge is only intended for use with the STRIVERDI RESPIMAT inhaler. Do not spray STRIVERDI into your eyes. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1 ‐ 800 ‐ FDA ‐ 1088. Read the step-by-step patient Instructions for Use for STRIVERDI RESPIMAT before you use your inhaler. Please see accompanying full Prescribing Information, including Patient Information, and Instructions for Use for STRIVERDI RESPIMAT. CL-STRR-100001 6.5.2019 Media Contact Michele Baer Human Pharma Communications [email protected] Boehringer Ingelheim 900 Ridgebury Road Ridgefield CT 06877 More information boehringer-ingelheim.com/us ISC-MPR-US 103150 - 05/24 SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

Drug Approval

01 May 2024

·www.fiercepharma.com

FTC targets Novo's Ozempic, others in crackdown on 300-plus 'junk' patent listings in FDA database

Federal Trade Commission Chair Lina Khan argued that pharma companies are using "bogus patent listings" in the FDA Orange Book to "block competition and inflate the cost of prescription drugs." The U.S. Federal Trade Commission (FTC) is not done with its crackdown on what it views as improper listing of patents with the FDA. After an initial round of challenges launched in November against more than 100 patents by nine drugmakers, the FTC is back targeting another 300-plus patent listings by eight pharma firms in the FDA’s Orange Book. The FTC argues those patents for altogether 20 brand-name products are “junk” listings that could be used by pharma companies to stymie competition and inflate drug prices. AstraZeneca, Boehringer Ingelheim, GSK and Teva once again found themselves in the crosshairs of the U.S. antitrust watchdog. But the most high-profile products involved in this wave of disputes, as spelled out by the FTC, are perhaps Novo Nordisk’s GLP-1 drugs Ozempic, Saxenda and Victoza. In response to a Fierce Pharma request for comment, Novo said it’s reviewing the warning letter received from the FTC. The antitrust agency in a Tuesday release mistakenly identified Ozempic as a weight loss drug when it’s only approved by the FDA to control Type 2 diabetes. Novo’s Wegovy, which contains the same GLP-1 receptor agonist semaglutide as Ozempic, is approved for obesity. The two brands, while both coming in an injectable pen administered weekly, are available in different maintenance dose strengths. The FDA Orange Book records branded drug patents that serve as reference for generic drug developers. The FTC argued that by putting up sham patents, biopharma companies have exploited a policy that blocks the FDA from approving a generic drug for 30 months if an originator timely files an infringement lawsuit against a generic over a patent listed in the Orange Book. The FTC first warned in September that it would scrutinize improperly listed drug patents in the FDA database. Then, in November, it challenged more than 100 patents for several drug products that deploys special delivery devices, such as an inhaler or an injector. In response, GSK, Amneal’s Impax Laboratories and Kaleo have delisted some patents. GSK also voluntarily removed certain patents that were not challenged by the FTC. Earlier this year, Boehringer Ingelheim, AZ and GSK all committed to capping their inhalers’ monthly out-of-pocket costs at $35. This time around, the FTC is once again eyeing some drug-device combos. Besides the Novo drugs, AstraZeneca’s Bydureon pen for diabetes is also part of the FTC’s challenge. Four GSK inhalers using the Ellipta device, such as the chronic obstructive pulmonary disease and asthma therapies Breo and Trelegy, were included. A GSK spokesperson confirmed receipt of the new warning letter and said the company will do its own analysis as the law requires. Previously, GSK retracted four of five patents flagged by the FTC from the Orange Book back in November. “Once complete, we will respond to the FDA and FTC in accordance with the FDA’s process,” the GSK spokesperson said of the latest review. For Novartis, its COPD drugs Seebri and Utibron landed on the FTC’s radar. Boehringer saw patents for its Striverdi and Stiolto inhalations using the Respimat technology under the agency’s microscope. In a statement shared with Fierce Pharma, Boehringer said it has “never wrongfully submitted patents for listing in the Orange Book—not for any of our inhaler products or any other products in our portfolio.” The company believes its patents in the FDA database are “valid, enforceable and properly listed.” “Drug-and-device combination products are complex and costly to develop and manufacture, and we file patents to protect our investment in innovations like these that benefit people and improve their lives.” Teva had the most patents implicated among the drugmakers, with about 60 patents targeted across five brands using the Respiclick, Digihaler or Redihaler platforms between it and its Norton Waterford subsidiary. The company did not immediately reply to a request for comment. Covis Pharma and Amphastar Pharmaceuticals round out the eight companies, The FTC is currently challenging the patents under the FDA’s regulatory dispute process, but the antitrust agency warned that it retains the right to take any further action. The FTC has yet to bring any additional sanctions against companies that have refused to remove patents in the agency’s first round of scrutiny.

Patent InfringementPatent Expiration

18 Mar 2024

·firstwordpharma.com

AstraZeneca to cap inhaler costs, following BI’s lead – and US investigation

AstraZeneca said Monday it’s capping out-of-pocket costs for US patients who use its asthma and chronic obstructive pulmonary disease (COPD) inhalers at $35 a month. The cost savings programme follows a similar move from Boehringer Ingelheim, who earlier this month set the same out-of-pocket limit on its inhalers. Both large pharmas may have been prompted to enact the payment cap after the US Senate launched an investigation into the high cost of inhaled respiratory medicines compared with other countries, such as the UK, Germany, and France. In January, the Senate Health, Education, Labor and Pensions committee sent letters to AstraZeneca and Boehringer Ingelheim, as well as GSK and Teva, requesting documentation on “internal decisions that ensure their inhalers do not face competition and can continue to bring in massive revenues.”According to the committee, inhalers from the four drugmakers can cost patients between $200 and $600 per month.The payment caps from Boehringer and AstraZeneca go into effect in June and will affect the UK pharma’s Airsupra (albuterol and budesonide), Bevespi aerosphere (glycopyrrolate and formoterol fumarate), Breztri aerosphere (budesonide, glycopyrrolate, and formoterol fumarate) and Symbicort (budesonide and formoterol fumarate dihydrate). AstraZeneca also announced that it has lowered the list price of Symbicort “substantially.”“We remain dedicated to addressing the need for affordability of our medicines, but the system is complex and we cannot do it alone,” CEO Pascal Soriot said in a statement. “It is critical that Congress bring together key stakeholders to help reform the healthcare system so patients can afford the medicines they need, not just today, but for the future.”Boehringer’s affected inhalers include Atrovent HFA (ipratropium bromide), Combivent Respimat (ipratropium bromide/albuterol) and Spiriva HandiHaler (tiotropium bromide), Spiriva Respimat (tiotropium bromide), Stiolto Respimat (tiotropium bromide/olodaterol) and Striverdi Respimat (olodaterol).

Drug Approval

100 Deals associated with Olodaterol Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D10020	Olodaterol Hydrochloride	R03AC19	DB09080

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	SG	Boehringer Ingelheim GmbH	24 Feb 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Xerophthalmia	Phase 2	JP	Santen Pharmaceutical Co., Ltd.	07 Feb 2023
Persistent asthma	Phase 2	US	Boehringer Ingelheim GmbH	01 Mar 2011
Persistent asthma	Phase 2	AT	Boehringer Ingelheim GmbH	01 Mar 2011
Persistent asthma	Phase 2	DE	Boehringer Ingelheim GmbH	01 Mar 2011
Persistent asthma	Phase 2	HU	Boehringer Ingelheim GmbH	01 Mar 2011
Persistent asthma	Phase 2	SK	Boehringer Ingelheim GmbH	01 Mar 2011
Persistent asthma	Phase 2	SI	Boehringer Ingelheim GmbH	01 Mar 2011
Asthma	Phase 2	FR	Boehringer Ingelheim GmbH	01 May 2007
Intermittent asthma	Phase 2	CA	Boehringer Ingelheim GmbH	01 Jan 2006
Liver Diseases	Phase 1	-	Boehringer Ingelheim GmbH	01 Jul 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


TONADO®/DYNAGITO® (Pubmed \| Adv Ther)	Phase 3	Pulmonary Disease, Chronic Obstructive	9,942	Tiotropium/olodaterol 5/5 µg	kihcziynut(csjwbihefy) = utzmihvzqk stvwdedjez (wkwsfkfyfj )	Positive	10 Aug 2020
				Tiotropium 5 µg	kihcziynut(csjwbihefy) = bzvfmtvnyq stvwdedjez (wkwsfkfyfj )
NCT02006732 \| NCT01431287 (Pubmed \| Adv Ther)	Phase 3	Pulmonary Disease, Chronic Obstructive First line	1,078	Tiotropium/Olodaterol 5/5 µg	geulfdbxcg(hspulugidn) = ktmhytlcsf lbroxnnttq (tjvqlorkbw, 0.033 - 0.079)	-	15 Jul 2020
NCT03240575 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	302	Tiotropium+Olodaterol (Tiotropium+Olodaterol (5μg/5μg) - Main Study)	vxjkydjwrv(clasyffdcu) = owmkzngmdp wozspywpsk (rkzaakeaak, qelyrrnrcz - abvytdzrms) View more	-	16 Apr 2020
				Fluticasone Propionate+Salmeterol (Fluticasone Propionate+Salmeterol (500μg/100μg) - Main Study)	vxjkydjwrv(clasyffdcu) = wvjvlmsngg wozspywpsk (rkzaakeaak, tcanuqrybc - guqymebafb) View more
TONADO 1, TONADO 2 (Pubmed \| Int J Chron Obstruct Pulmon Dis)	Not Applicable	Pulmonary Disease, Chronic Obstructive	506	tiotropium/olodaterol 5/5 µg combination therapy	nudnbwgnyv(nhfdijkkxe) = qngfkpvtru pcbtvvpgut (dvkxxbiakd )	-	01 Jan 2020
				tiotropium 5 µg	nudnbwgnyv(nhfdijkkxe) = ompjhasvzo pcbtvvpgut (dvkxxbiakd )
ERS2019	Not Applicable	Pulmonary Disease, Chronic Obstructive	78	Tiotropium	wncfwjahsa(xpqtfkjgxs) = lxkrslxuls visaqwwysn (vrkglvjsjx ) View more	Positive	28 Sep 2019
				Tiotropium/olodaterol	wncfwjahsa(xpqtfkjgxs) = imrxzstxdw visaqwwysn (vrkglvjsjx ) View more
NCT03055988 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive \| Stiffness	76	Salmeterol FDC+Fluticasone Propionate (Fluticasone Propionate + Salmeterol FDC (F+S 1000/100))	ylivwrjgcr(tjxvzwpnvf) = qrccircbqn tlsotezmpw (ulakoowznm, hvfklkmcnt - ouosidldvg) View more	-	16 Aug 2019
				Tiotropium+Olodaterol (Tiotropium + Olodaterol FDC (T+O 5/5))	ylivwrjgcr(tjxvzwpnvf) = vbfqkudcll tlsotezmpw (ulakoowznm, ojhpbzkutb - bdomvknguc) View more
NCT02629965 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	184	Tiotropium (Tiotropium 5 μg)	xnvttwhumm(ajirsrjgza) = cjanyguvhr rrdcamdrjd (ollpimnjnn, oeqtjxitge - incxwbghwj) View more	-	06 Jun 2019
				Tiotropium+Olodaterol (Tiotropium + Olodaterol 5/5 μg)	xnvttwhumm(ajirsrjgza) = yoppisckxy rrdcamdrjd (ollpimnjnn, ksclnlopyq - vditzkdbyq) View more
NCT02969317 (CTgov)	Phase 1	Pulmonary Disease, Chronic Obstructive	12	Tiotropium+Olodaterol	ignedwpvre(zdtpbxnxns) = umxlfxppfl rlpzzwpygz (imahwvwxvj, zkqihfgzdn - sdgtoavnpe) View more	-	29 Mar 2019
NCT02296138 (DYNAGITO, CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	7,903	Tiotropium (Tiotropium 5 Microgram (μg))	kodxdsunqg(nblmqdwail) = etlkofusal rbpdjtliqw (ygfqlcejhh, ekzjavpgwk - gualsoddfg) View more	-	04 Jun 2018
				Tiotropium+Olodaterol (Tiotropium (5 μg) + Olodaterol (5 μg))	kodxdsunqg(nblmqdwail) = xzsebgwggf rbpdjtliqw (ygfqlcejhh, kizlkodcjg - oagzsuecuy) View more
NCT01040130 \| NCT01040793 (Pubmed \| Respir Res)	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Olodaterol 5 μg	pcuphhajzu(gvsgrezuxx) = uhbdbgzqdx tqnfettlpc (dcdawgxlas ) View more	-	06 Jul 2016
				Olodaterol 10 μg	pcuphhajzu(gvsgrezuxx) = eepnacxlkj tqnfettlpc (dcdawgxlas ) View more

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