Trevi Therapeutics has been granted a patent for a method of treating chronic cough and idiopathic pulmonary fibrosis (IPF) cough using nalbuphine compositions. The method involves orally administering nalbuphine or a pharmaceutically acceptable salt or ester to provide a therapeutic effect in patients. GlobalData’s report on Trevi Therapeutics gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on Trevi Therapeutics, nanoparticle drug conjugates was a key innovation area identified from patents. Trevi Therapeutics's grant share as of June 2023 was 1%. Grant share is based on the ratio of number of grants to total number of patents.

Treating idiopathic pulmonary fibrosis (ipf) cough

Source: United States Patent and Trademark Office (USPTO). Credit: Trevi Therapeutics Inc

A recently granted patent (Publication Number: US11660296B2) discloses a method for treating idiopathic pulmonary fibrosis (IPF) cough. The method involves orally administering nalbuphine or a pharmaceutically acceptable salt or ester thereof to a patient in need.

The patent claims specify various aspects of the method. Claim 2 states that the IPF cough being treated is chronic cough. Claims 3 and 4 describe the desired mean AUCtau (area under the concentration-time curve) in the patient, ranging from about 40 ng·hr/mL to about 800 ng·hr/mL or about 40 ng·hr/mL to about 200 ng·hr/mL, respectively. Similarly, claims 5 and 6 specify the desired mean Cmax (maximum concentration) in the patient, ranging from about 5 ng/mL to about 85 ng/mL or about 6.28 ng/mL to about 82.78 ng/mL, respectively.

The patent also provides information on the dosage of nalbuphine or its equivalent amount in the form of nalbuphine free base. Claims 7 to 14 outline different total daily doses and frequencies of administration, ranging from about 27 mg to about 324 mg of nalbuphine free base. The method can involve once-daily or twice-daily administration, with varying doses depending on the patient's condition.

The duration of treatment is addressed in claims 15 and 16, which state that the administering can be for at least 1 week or for longer periods such as 8 weeks, 10 weeks, 12 weeks, 24 weeks, or 52 weeks.

The patent also covers the process of titrating the dose of nalbuphine to achieve a steady state in the patient. Claims 17 to 21 describe different titration methods, including initial doses and incremental dose adjustments.

Claims 22 and 23 highlight the desired reduction in cough frequency after treatment, with at least a 30% or 50% reduction in daytime cough frequency compared to before treatment.

The patent further mentions that nalbuphine or its pharmaceutically acceptable salt or ester can be in the form of nalbuphine hydrochloride or an extended-release oral dosage form. Additionally, the method can involve administering nalbuphine in combination with other therapeutic agents such as nintedanib and pirfenidone.

In conclusion, the granted patent discloses a method for treating IPF cough using nalbuphine or its pharmaceutically acceptable forms. The method involves specific dosages, administration frequencies, and treatment durations, with the goal of reducing cough frequency in IPF patients.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies