Theravance Biopharma, Inc. Announces Enrollment of First Patient in YUPELRI® Phase 4 Study
"YUPELRI, discovered and developed by Theravance, is one of the key pillars of value creation for the go-forward organization. We, and our partner Viatris, believe we have just scratched the surface of YUPELRI's contribution to the COPD community," said Rick E Winningham, Chief Executive Officer. "The enrollment of the first patient in the Phase 4 PIFR-2 study demonstrates, through continued investment in controlled clinical studies, our commitment to provide healthcare professionals with the evidence needed to design personalized treatment plans in order to make better informed decisions for their COPD patients."
About the PIFR-2 Study
This study (NCT05165485) is a randomized, double-blind, parallel-group study, comparing improvements in lung function in adults with severe to very severe COPD and suboptimal inspiratory flow rate following once-daily treatment over 12 weeks with either YUPELRI (revefenacin) inhalation solution delivered via standard jet nebulizer or SPIRIVA® (tiotropium) delivered via a dry powder inhaler (Spiriva® HandiHaler®) (n=366).
The Company expects to report top-line results in first quarter 2023.
YUPELRI® (revefenacin) inhalation solution is a once-daily nebulized long-acting muscarinic antagonist (LAMA) approved for the maintenance treatment of COPD in the US. LAMAs are recognized by international COPD treatment guidelines as a cornerstone of maintenance therapy for COPD, regardless of severity of disease. Our market research indicates there is an enduring population of COPD patients in the US that either need or prefer nebulized delivery for maintenance therapy. The stability of revefenacin in both metered dose inhaler and dry powder inhaler ("MDI/DPI") formulations suggests that revefenacin could also serve as a foundation for novel handheld combination products.
Important Safety Information
What is YUPELRI®?
- YUPELRI is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD), a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.
- It is an anticholinergic medicine which helps the muscles around the airway in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath.
- It is used long-term as 1 vial of YUPELRI, 1 time each day inhaled through your nebulizer to improve symptoms of COPD for better breathing.
Who should not use YUPELRI?
- Do not use YUPELRI if you have sudden breathing problems. Always have a rescue inhaler with you.
- Do not use YUPELRI if you have had an allergic reaction to revefenacin, or any of the other ingredients in YUPELRI (sodium chloride, citric acid, sodium citrate).
- Do not use in children. It is not known if YUPELRI is safe and effective in children.
Before using YUPELRI, tell your healthcare provider about all your medical conditions, including if you:
- have eye problems such as glaucoma. YUPELRI may make your glaucoma worse.
- have prostate or bladder problems, or problems passing urine. YUPELRI may make these problems worse.
- have liver problems.
- are allergic to any of the ingredients in YUPELRI, or any other medicines.
- are pregnant or planning to become pregnant. It is not known if YUPELRI may harm your unborn baby.
- are breastfeeding. It is not known if the medicine in YUPELRI passes into your breast milk and if it can harm your baby.
Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. YUPELRI and certain other medicines may interact with each other. This may cause serious side effects.
Especially tell your healthcare provider if you take:
- Other anticholinergics (including tiotropium, ipratropium, aclidinium, umeclidinium, glycopyrrolate)
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
What are the possible side effects with YUPELRI?
YUPELRI can cause serious side effects, including:
- Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using YUPELRI and call your healthcare provider right away.
- New or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms may include:
- Red eyes
- Blurred vision
- Seeing halos or bright colors around lights
- Eye pain or discomfort
- Nausea or vomiting
- Urinary retention. People who take YUPELRI may develop new or worse urinary retention. Symptoms of urinary retention may include:
- difficulty urinating
- urinating frequently
- urination in a weak stream or drips
- painful urination
If you have any of these symptoms, call your healthcare provider right away before taking another dose.
- Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
- severe itching
- swelling of your face, mouth, and tongue
- difficulty breathing or swallowing
If you have any of these symptoms, stop taking YUPELRI, and call your healthcare provider right away before taking another dose.
Common side effects of YUPELRI include:
- Runny nose
- Upper respiratory tract infection
- Back pain
Tell your healthcare provider if you get any side effects that bother you or that do not go away. These are not all the possible side effects with YUPELRI. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I use YUPELRI?
Read the step by step instructions for using YUPELRI at the end of this Patient Information Leaflet
- YUPELRI is only for use with a nebulizer.
- Do not use YUPELRI more often than prescribed.
- Do not mix YUPELRI with other medicines in your nebulizer.
- Do not use other medicines that contain an anticholinergic for any reason.
- Do not stop using YUPELRI, even if you are feeling better, unless your healthcare provider tells you to because your symptoms might get worse.
- Call your healthcare provider or get emergency medical care right away if
- your breathing problems get worse.
- you need to use your rescue inhaler medicine more often than usual.
- your rescue inhaler medicine does not relieve your symptoms.
This summary does not include all the information about YUPELRI and is not meant to take the place of a discussion with your healthcare provider about your treatment.
In pursuit of its purpose, Theravance Biopharma leverages decades of respiratory expertise to discover and develop transformational medicines that make a difference. These efforts have led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Its respiratory pipeline of internally discovered programs is targeted to address significant patient respiratory needs.
Theravance Biopharma has an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY.
For more information, please visit www.theravance.com.
YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris Company. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.
This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events.
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