A clinical trial in the U.K. is recruiting people with idiopathic pulmonary fibrosis (IPF) to test Trevi Therapeutics’ nalbuphine extended release tablets to treat chronic cough, the company announced.
Nalbuphine extended release (ER) acts in two ways: the small molecule blocks the mu opioid receptor, while it activates the kappa opioid receptor. Opioid receptors are believed to play an important role in the control of respiration and cough.
The Phase 2 CANAL trial (NCT04030026) is testing the safety, tolerability, and efficacy of nalbuphine ER versus a placebo to treat chronic cough in up to 56 patients with IPF.
The trial is recruiting participants across several clinical sites in the United Kingdom. Information on enrollment is found on the trial’s page.
Participants will be randomly assigned to a three-week treatment with nalbuphine ER followed by three weeks on a placebo, or vice-versa, with one week of “washout” in between. A washout is a period of time during a clinical study when a participant is taken off the therapy being test (or other medication) so as to eliminate any residual effects of the treatment.
Nalbuphine ER will be given at a dose of 27 mg once daily, increasing to 54 mg twice-a-day over a five-day period, and then maintained at this dose for four days. Doses will subsequently be escalated and maintained at 108 mg twice-a-day over one week, and then to 162 mg twice-a-day over six days.
The trial’s main outcome (endpoint) is to assess a patient’s response to treatment, namely the mean daytime cough frequency at day 22, compared with the placebo. Daytime was defined as the period during the day when a person is awake.
Trevi is “actively enrolling the cough study in idiopathic pulmonary fibrosis patients in the U.K., and expect to report top-line data in the second half of 2020,” Jennifer L. Good, president and CEO of Trevi Therapeutics, said in a press release.
Top-line data is expected by June 2020.
Nalbuphine ER is also being tested for other conditions, including prurigo nodularis, a rare skin disease that causes hard, itchy lumps to form on the skin.
Nalbuphine has been approved and marketed as an injectable for more than 20 years, in both the United States and Europe, for in-hospital relief of moderate to severe pain. It is currently the only opioid approved for such indications that is not classified as a controlled substance.
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