The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)

Exclusion Criteria

• •Clinical diagnosis of sleep apnea and/or use of continuous positive airway pressure (CPAP).
• •Upper or lower respiratory tract infection or change in pulmonary status in the 4 weeks prior to the Screening visit or during the Screening or PBO Run-in periods.
• •History of bronchiectasis, chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF), or other significant respiratory disorder that might affect cough.
• •History of uncontrolled asthma defined as one of the following:
• •* ≥1 clinically significant exacerbation in the last 6 months, OR
• •* ≥2 clinically significant exacerbations in the past 12 months (a clinically significant asthma exacerbation is defined as requiring the use of systemic corticosteroids).
• •Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or nicotine vaper.
• •Individuals who have stopped smoking or vaping within the past 6 months, or those with \>20 pack-year smoking history.
• •Current active tuberculosis or nontuberculous mycobacterial infection, a history of latent untreated tuberculosis, or a history of incompletely treated tuberculosis.
• •Speech therapy/physiotherapy for RCC starting within 4 weeks of Baseline or during the study. Speech therapy/physiotherapy is acceptable if the participant has started the therapy more than 4 weeks prior to the Baseline visit AND plans to continue the therapy through the Titration and Fixed-dose Treatment Period.
• •Known intolerance \[gastrointestinal, central nervous system (CNS) symptoms\], hypersensitivity, or drug allergy considered to be related to an opioid drug or known hypersensitivity to nalbuphine or to NAL ER excipients.