We are developing nalbuphine ER to treat serious neurologically mediated conditions by targeting the central and peripheral nervous systems. Nalbuphine ER is an oral, extended-release formulation of nalbuphine, which has a long history of efficacy and safety, having been approved for more than 20 years in the United States and Europe as a subcutaneous injection for relief of moderate to severe pain in the hospital setting. Our novel oral formulation has the potential to unlock new market opportunities and significantly improve the quality of life of patients who currently have few treatment options.
Nalbuphine has a unique mechanism of action, acting as both an antagonist (blocker) to the bodyâs mu opioid receptor and as an agonist (activator) to the kappa opioid receptor. The kappa and mu opioid receptors are known to be critical mediators of the urges to scratch and cough, as well as of certain movement disorders. Nalbuphineâs mechanism of action also mitigates the risk of abuse associated with mu opioid agonists because it blocks the mu opioid receptor. Nalbuphine is currently the only opioid approved for marketing that is not a controlled substance in the United States or Europe.
We are developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF), and levodopa-induced dyskinesia (LID) in patients with Parkinsonâs disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Our pivotal Phase 2b/3 clinical trial of nalbuphine ER (PRISM) is currently enrolling patients with severe pruritus associated with prurigo nodularis (PN). In addition, we initiated a Phase 2 clinical trial of nalbuphine ER for the treatment of chronic cough in patients with IPF and we are preparing to initiate a Phase 2 clinical trial of nalbuphine ER for the treatment of LID in patients with Parkinsonâs disease.
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