Methods of treating respiratory depression modulated by a non-opioid agent
Inventors
PERGOLIZZI, Joseph • Miller, Thomas • Schweikert, Alfred
Assignees
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Publication Number
US-12138267-B2
Publication Date
2024-11-12
Expiration Date
Abstract
Disclosed in certain embodiments is a method of treating respiratory depression modulated by a non-opioid agent comprising administering, to a patient in need thereof, an effective amount of a compound selected from Formula (I) as disclosed herein.
Core Innovation
The invention relates to treating respiratory depression caused by a non-opioid agent, including propofol, by administering an effective amount of a compound of Formula (I) and pharmaceutically acceptable salts thereof to a patient in need thereof. The disclosure characterizes the approach as specific to respiratory depression arising from non-opioid central nervous system depressants and includes embodiments defined by extensive structural variable definitions for Formula (I).
The disclosed embodiments include alkynyl-substituted variants of the compound and pharmaceutically acceptable salts, together with pharmaceutical composition concepts. The disclosure further describes treatment associated with restored ventilatory sufficiency and restored ventilator sufficiency, including potential mitigation of ventilatory degradation and improvements in hypoxic and hypercapnic ventilatory responsiveness.
The disclosure distinguishes the proposed activity from opioid antagonists such as naloxone by asserting functional distinctions, while still addressing clinical monitoring endpoints using ventilatory and blood-gas related measures. Reported measures include minute ventilation, tidal volume, respiratory rate, end-tidal CO2, and SpO2, along with pharmacokinetic-related metrics such as Cmax, AUCinf, and terminal half-life, and referenced ventilation responses in the figures.
Claims Coverage
The independent claim covers treating respiratory depression caused by a non-opioid agent, propofol, by administering an effective amount of a compound of Formula (I) or a pharmaceutically effective salt. The dependent claims specify six inventive features using clinical criteria, sedation conditions, hypoxemic and hypercapnic events, and a broad list of permitted administration routes.
Treating respiratory depression caused by a non-opioid agent with propofol
Administering, to a patient in need thereof, an effective amount of the compound, or a pharmaceutically effective salt thereof, wherein the non-opioid agent is propofol.
Restored ventilatory sufficiency
The patient exhibits restored ventilatory sufficiency.
Restored ventilator sufficiency under normal, low, or high sedation
The patient exhibits restored ventilator sufficiency under normal, low, or high sedation.
Increased ventilatory responsiveness during hypoxemic events
The patient exhibits increased ventilatory responsiveness during hypoxemic events.
Increased ventilatory responsiveness to hypercapnic events
The patient exhibits increased ventilatory responsiveness to hypercapnic events.
Route of administration selected from a listed set
The route of administration is chosen from the listed set of administration routes.
Overall, the claim set centers on administering a compound or pharmaceutically effective salt for treating propofol-associated respiratory depression, with dependent coverage specifying restored ventilatory or ventilator sufficiency, increased ventilatory responsiveness during hypoxemic and hypercapnic events, and administration by multiple listed routes.
Stated Advantages
Restored ventilatory sufficiency and restored ventilator sufficiency.
Increased hypoxic and hypercapnic ventilatory responsiveness.
Avoidance or minimization of ventilatory degradation.
Potential improvements in SpO2 and blood-gas measures.
Documented Applications
Treatment of respiratory depression caused by non-opioid central nervous system depressants, wherein the non-opioid agent is propofol.
Treatment evaluated using clinical endpoints including restored ventilatory sufficiency or ventilator sufficiency and increased ventilatory responsiveness to hypoxemic and hypercapnic events.
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