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-9616054-B2
Publication Date
2017-04-11
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 disclosed invention provides an injectable composition comprising a combination of bupivacaine and clonidine for administration by injection to a cervical sympathetic ganglion. The composition is described as a mixture suitable for cervical sympathetic ganglion delivery.
The disclosure addresses treating post-traumatic stress disorder and/or hot flashes using right-sided cervical sympathetic ganglion injection delivered to a cervical sympathetic ganglion. The approach is framed as enhancing and prolonging sympathetic blockade, with faster onset and reduced local anesthetic absorption relative to local anesthetic alone.
The disclosure further provides mechanistic background linking stellate/stellate-to-amygdala/hypothalamus pathways and a proposed NGF→NE stress cascade. It also compares the approach to prior “Chicago Block” using local anesthetic alone and includes case-study style outcomes suggesting added benefit of clonidine.
Claims Coverage
The claims coverage centers on an injectable composition that combines bupivacaine and clonidine and specifies administration by injection to a cervical sympathetic ganglion. Dependent claim refinements add cervical sympathetic ganglion targeting, dose and volume constraints, formulation constraints, and therapeutic treatment of post-traumatic stress disorder and/or hot flashes.
Injectable bupivacaine and clonidine combination for cervical sympathetic ganglion injection
An injectable composition comprising a combination of bupivacaine and clonidine, wherein the composition is administered to a patient via an injection to a cervical sympathetic ganglion.
Cervical sympathetic ganglion dose volume constraint
A composition wherein a dose has a volume of from 2 to 50 cc.
Bupivacaine 0.5% with clonidine amount in at least a 12 mL solution
A composition includes at least a 12 mL solution of bupivacaine 0.5% containing 50 mcg of clonidine.
Bupivacaine concentration range in solution
A composition includes a range from 0.005 µg/cc to 40 µg/cc of bupivacaine.
Preservative-free 0.9% saline vehicle
The preservative free sterile saline solution is a preservative free 0.9% saline solution.
Effective dose for treating PTSD and/or hot flashes
The composition includes an effective dose of a bupivacaine and clonidine combination formulation to treat at least one of post-traumatic stress disorder and hot flashes.
Overall, the independent claim is directed to an injectable bupivacaine-and-clonidine composition administered by injection to a cervical sympathetic ganglion, while the dependent claims refine the inventive features with dose volume, solution volume and component amounts, bupivacaine concentration ranges, a preservative-free 0.9% saline vehicle, and effectiveness for treating post-traumatic stress disorder and/or hot flashes.
Stated Advantages
Enhanced and longer sympathetic blockade.
Faster onset.
Reduced local anesthetic absorption.
Documented Applications
Treating post-traumatic stress disorder (PTSD) via right-sided cervical sympathetic ganglion injection (RCSGI) delivering a bupivacaine and clonidine mixture to a cervical sympathetic ganglion.
Treating hot flashes via right-sided cervical sympathetic ganglion injection (RCSGI) delivering a bupivacaine and clonidine mixture to a cervical sympathetic ganglion.
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