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-9603843-B2
Publication Date
2017-03-28
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 document discloses treating a patient having a condition, other than pain, that is responsive to a cervical sympathetic ganglion blockade by administering an injection of a local anesthetic and an alpha-2-adrenergic agonist. The injection is administered in a sequential order by first administering the injection at at least one of cervical vertebrae 6 and cervical vertebrae 7, followed by administering the injection at cervical vertebrae 3. In an embodiment specifically directed to post-traumatic stress disorder (PTSD), the injection includes bupivacaine and clonidine.
The approach is described in the context of cervical sympathetic ganglion blockade and relates to the stellate ganglion connections to the amygdala and hypothalamus. The document further supports a mechanism involving nerve growth factor (NGF) neurite outgrowth and a norepinephrine cascade, with modulation by local anesthetic and enhancement of sympathetic blockade via clonidine.
The document also discloses kit aspects for carrying out the treatment, including options for a kit with a single vial mixture or separate vials, sterile syringes, and optional inserts or devices. Example case reports are described, including pediatric and adult responses, with outcomes assessed using a Post-Traumatic Stress Disorder Checklist (PCL).
Claims Coverage
The partial claims provided include two independent claims. Across these claims, there are 3 main inventive elements: treating a non-pain condition responsive to cervical sympathetic ganglion blockade, administering an injection containing a local anesthetic and an alpha-2-adrenergic agonist in a specified sequential vertebral order, and a specific PTSD embodiment using bupivacaine and clonidine with the same sequential vertebral order.
Sequential cervical vertebrae injection order for non-pain responsive conditions
Administering an injection of a local anesthetic and an alpha-2-adrenergic agonist by first administering at least one of cervical vertebrae 6 and cervical vertebrae 7, followed by administering the injection at cervical vertebrae 3.
Cervical sympathetic ganglion blockade with local anesthetic plus alpha-2-adrenergic agonist
Providing a method for treating a patient having a condition, other than pain, that is responsive to a cervical sympathetic ganglion blockade, by administering an injection of a local anesthetic and an alpha-2-adrenergic agonist.
PTSD treatment with bupivacaine and clonidine using staged cervical vertebrae targeting
Treating a patient suffering from post-traumatic stress disorder (PTSD) by administering an injection of bupivacaine and clonidine, where the injection is first administered at at least one of cervical vertebrae 6 and cervical vertebrae 7 and followed by administering the injection at cervical vertebrae 3.
The claim set provided centers on staged administration at cervical vertebrae 6/7 followed by cervical vertebra 3, using an injection containing a local anesthetic and an alpha-2-adrenergic agonist for conditions responsive to cervical sympathetic ganglion blockade, including a PTSD-specific embodiment with bupivacaine and clonidine.
Stated Advantages
Increased duration and faster onset of sympathetic blockade.
Increased block intensity.
Reduced local anesthetic absorption.
Improved efficacy and/or relief duration for PTSD and hot flashes.
Reduced risk of local-anesthetic absorption-related complications.
Documented Applications
Treating post-traumatic stress disorder (PTSD).
Treating hot flashes.
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