Kits and methods for treating post traumatic stress disorder (PTSD) and hot flashes
Inventors
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Assignees
MemberCAD TherapeuticsCAD TherapeuticsCAD Therapeutics is a privately-held U.S.-based biotechnology company advancing an investigational, fixed-dose bupivacaine and clonidine formulation administered via stellate ganglion block. The company's primary focus is on addressing the physiological dimension of post-traumatic stress disorder (PTSD) through a pivotal Phase III candidate program, with expansion potential to other indications such as vasomotor symptoms. The development strategy utilizes a 505(b)(2) regulatory pathway and is supported by an issued and pending intellectual property estate.
CAD Therapeutics is a privately-held U.S.-based biotechnology company advancing an investigational, fixed-dose bupivacaine and clonidine formulation administered via stellate ganglion block. The company's primary focus is on addressing the physiological dimension of post-traumatic stress disorder (PTSD) through a pivotal Phase III candidate program, with expansion potential to other indications such as vasomotor symptoms. The development strategy utilizes a 505(b)(2) regulatory pathway and is supported by an issued and pending intellectual property estate.
Publication Number
US-8987327-B1
Publication Date
2015-03-24
Expiration Date
Abstract
The present invention is directed to kits and methods for the treatment of a patient suffering from post-traumatic stress disorder (PTSD) and/or hot flashes by an administration of a mixture produced by a combination of a long acting local anesthetic combined with clonidine. The combination of the two pharmaceuticals produces a significant increase in duration and speed of onset of sympathetic blockade, increased intensity of the sympathetic blockage as well as the reduction of local anesthetic absorption locally. The combination significantly improves the efficacy, speed of onset and block intensity of a right sided cervical sympathetic ganglion injection (RCSGI) leading to increased length of resolution of PTSD and hot flashes as well as reducing the potential for complications related to absorption of the local anesthetic.
Core Innovation
The invention relates to treatment and related kit compositions for a medical condition selected from the group consisting of post-traumatic stress disorder and hot flashes. The treatment comprises administering an injection at a cervical sympathetic ganglion, and the injection includes a local anesthetic and clonidine.
The disclosure states that the mixture of long-acting local anesthetic and injectable clonidine administered at a right sided cervical sympathetic ganglion injection provides increased duration and speed or intensity of sympathetic blockade compared with local anesthetic alone. The disclosure further states that clonidine inclusion reduces local anesthetic absorption and improves efficacy and clinical resolution while reducing complications.
The disclosure provides a mechanistic discussion linking stellate ganglion or cervical sympathetic ganglion pathways to PTSD-associated brain regions including amygdala and hypothalamus. The disclosure describes a nerve growth factor (NGF)norepinephrine (NE) cascade to support the treatment concept, and it also describes illustrative case examples including PTSD cases and a menopausal hot flashes case showing faster and stronger effects when clonidine is included.
Claims Coverage
The partial content provides one independent claim with an injection-based method for treating post-traumatic stress disorder or hot flashes by administering a local anesthetic and clonidine at a cervical sympathetic ganglion. Dependent features specify particular long-acting local anesthetics, mixing into a solution, cervical injection variants, dosage range constraints, and kit-related components and documentation.
Treating post-traumatic stress disorder and hot flashes with local anesthetic and clonidine at a cervical sympathetic ganglion
A method for treating a patient with a medical condition selected from post-traumatic stress disorder and hot flashes by administering an injection of a local anesthetic and clonidine, where the injection is administered at a cervical sympathetic ganglion.
Across the independent claim and its refinements disclosed in the partial content, the core inventive approach is to treat post-traumatic stress disorder and/or hot flashes using an injection at a cervical sympathetic ganglion that combines a local anesthetic with clonidine. Dependent features disclosed include selection of specific long-acting local anesthetics, combination into a solution, cervical targeting variants, dosage range constraints, and kit packaging and manual content.
Stated Advantages
Increased duration of sympathetic blockade.
Increased speed and/or intensity of sympathetic blockade.
Reduced local anesthetic absorption.
Improved efficacy and clinical resolution.
Reduced complications.
Documented Applications
Treatment of a patient with post-traumatic stress disorder using an injection of a local anesthetic and clonidine administered at a cervical sympathetic ganglion, including illustrative PTSD pediatric and adult survivor case examples.
Treatment of hot flashes using an injection of a local anesthetic and clonidine administered at a cervical sympathetic ganglion, including an illustrative menopausal hot flashes case example.
Kit use for administering the injection and for including a manual for pre- and post-injection screening to diagnose PTSD and hot flashes.
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