Intravenous baclofen formulations and treatment methods
Inventors
Cloyd, James C. • Gomez, Adolfo L. • Krach, Linda • Kriel, Robert L. • Schrogie, John • Tucker, Stephen John • Tuohy, Rob
Assignees
Allaysis LLC • University of Minnesota System
Publication Number
US-12295929-B2
Publication Date
2025-05-13
Expiration Date
2036-01-15
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Abstract
An intravenous baclofen solution is disclosed, along with methods of dosing and treatment therewith.
Core Innovation
The invention provides an intravenous baclofen solution and methods for its dosing and administration, particularly for treating or preventing baclofen withdrawal during periods when oral or intrathecal administration of the drug is interrupted. The intravenous solution allows for rapid attainment of therapeutic baclofen concentrations and offers precise and controlled dose titration. This approach is intended as a temporary treatment for patients whose access to oral or intrathecal baclofen is compromised, thus supporting the management of withdrawal or prevention of withdrawal symptoms.
Specifically, the invention discloses methods of discontinuing oral or intrathecal baclofen and administering to the patient a bolus or continuous intravenous infusion of baclofen at defined concentrations and intervals, with subsequent resumption of oral or intrathecal administration once feasible. The intravenous baclofen solution can be prepared in concentrations of up to about 2.0 mg/mL, utilizing normal saline, dextrose solution, Lactated Ringer's solution, or combinations thereof.
The problem addressed by this invention is the inadequacy of current management strategies for baclofen withdrawal, which can occur due to medical events preventing oral or intrathecal administration. Abrupt discontinuation of baclofen may result in severe withdrawal symptoms such as increased muscle tone, spasms, status epilepticus, hallucinations, and potentially life-threatening complications. There is a clinical need for an intravenous formulation to prevent or minimize complications from interrupted therapy.
Claims Coverage
There are three independent claims, each defining inventive features related to methods for treating or preventing baclofen withdrawal using intravenous baclofen solutions.
Bolus intravenous administration of baclofen for withdrawal treatment
A method of treating or preventing baclofen withdrawal in a human subject currently treated with a therapeutically effective amount of oral baclofen, comprising: 1. Discontinuing oral administration of the therapeutic dose. 2. Administering a bolus intravenous dose of solution comprising about 75% of the oral baclofen amount. 3. Repeating the bolus intravenous dose every 6 to 8 hours.
Continuous intravenous infusion for withdrawal treatment
A method of treating or preventing baclofen withdrawal in a human subject currently treated with a therapeutically effective amount of oral baclofen, comprising: 1. Discontinuing oral administration of the therapeutic dose. 2. Administering a continuous intravenous infusion of solution comprising about 75% of the oral baclofen amount over approximately 24 hours.
Continuous intravenous infusion repeated every 24 hours
A method of treating or preventing baclofen withdrawal in a human subject presently being treated with a therapeutically effective amount of oral baclofen, comprising: 1. Discontinuing oral administration of the therapeutic dose. 2. Administering a continuous intravenous infusion of solution comprising about 75% of the oral baclofen amount. 3. Continuing the infusion approximately every 24 hours.
The independent claims define inventive methods centered on the substitution of oral baclofen with precisely dosed intravenous solutions, using bolus or continuous administration protocols, to effectively prevent or treat baclofen withdrawal.
Stated Advantages
Intravenous administration of baclofen permits rapid attainment of necessary drug concentrations and allows accurate and precise dose titration.
The methods enable more efficient and effective treatment of withdrawal symptoms or preventing withdrawal altogether.
Continuous intravenous infusion of baclofen can mimic intrathecal administration and may eliminate or mitigate peaks or troughs in drug levels, reducing the risk or incidence of adverse events associated with intravenous baclofen.
Documented Applications
Temporary treatment of patients with baclofen during periods of medical fluctuation, such as illness, surgery, or medical conditions that interrupt oral or intrathecal administration.
Bridging therapy for patients temporarily unable to take oral or intrathecal baclofen due to events like scheduled or unscheduled surgeries, trauma, gastrointestinal issues, seizures, or hardware failures in intrathecal pumps.
Conversion of oral baclofen dosing to intravenous dosing during temporary discontinuation of oral therapy.
Management and prevention of baclofen withdrawal symptoms including rebound increases in muscle tone, spasms, status epilepticus, hallucinations, neuromalignant syndrome-like conditions, rhabdomyolysis, and multisystem organ failure.
Interested in licensing this patent?