Cough Reduction in IPF With Nalbuphine ER

Exclusion Criteria

• •Currently on continuous oxygen therapy for longer than 16 hours at any level or delivered by any modality. Intermittent oxygen use of any duration over any given 24-hour period is allowed.
• •Inadequate swallow reflex as assessed by the ability to sip 3 fluid oz (or 89 mL) of water without coughing or choking.
• •Upper or lower respiratory tract infection in the last 8 weeks prior to the baseline visit.
• •Clinical history of aspiration pneumonitis.
• •Diagnosis of sleep apnea.
• •Abnormal kidney or liver functions based on Screening lab results.
• •Known hypersensitivity to nalbuphine or to NAL ER excipients
• •History of major psychiatric disorder.
• •History of substance abuse.
• •Significant medical condition or other factors that may interfere with the participant's ability to successfully complete the study.
• •Pregnant or lactating female participant.
• •Known intolerance (gastrointestinal, central nervous system symptoms), hypersensitivity, drug allergy following the use of an opioid drug.
• •Use of opiates is prohibited within 14 days prior to the baseline visit.
• •Use of benzodiazepines are prohibited within 14 days prior to the baseline visit and for the duration of the study.
• •Monoamine oxidase inhibitors (MAOIs) including methylene blue (methylthioninium chloride) and the antibiotic linezolid are prohibited within 14 days prior to the baseline visit and for the duration of the study.
• •Use of oral corticosteroid cough treatment is prohibited within 4 weeks prior to the baseline visit and for the duration of the study.
• •Exposure to any investigational medication, including placebo, is prohibited within 4 weeks prior to the baseline visit and for the duration of the study.
• •Medications prescribed as cough suppressants are prohibited unless on a stable dose 14-days prior to the baseline visit and are expected to remain on that dose for the duration of the study.
• •Use of medications that affect serotonergic neurotransmission and that when used concomitantly with opioids can increase the risk of serotonin syndrome are prohibited unless on a stable dose 14-days prior to the baseline visit and are expected to remain on that dose for the duration of the study.
• •Anti-fibrotic medications are prohibited unless on a stable dose for 8 weeks prior to the baseline visit and are expected to remain on that dose for the duration of the study.
• •Strong inhibitors/inducers of the P450 Isozymes are prohibited unless on a stable dose for 14-days prior to baseline visit and are expected to remain on that dose for the duration of the study.
• •Use of a medication having a "known risk" of Torsade de Pointes (categorized as "KR" on the Credible Meds® website.) 4 weeks prior to Baseline.
• •Use of unstable doses of medications associated with a potential risk of QT prolongation but not clearly associated with Torsade de Pointes within 4 weeks of screening.