Warsaw Orthopedic, Inc.

Warsaw Orthoperic, Inc.

Josee Roy

William F McKay

Susan J Drapeau

Jeffrey C Marx

Daniel A Shimko

Danielle L Clay

Hai H Trieu

Jeffrey Mendel Gross

Roger E Harrington

John Myers Zanella

Michael J Schendel

Jared T Wilsey

Scott P Noel

Toya Kimble

Andrew J Lowenthal Walsh

Mingfei Chen

Hezi-Yamit Ayala

Carol Sullivan

Victor Kelley

Danielle L Biggs

Jeffery C Marx

Jonathan K Gray

Effective treatments of pain for extended periods of time are provided. Through the administration of an effective amount of clonidine in a drug depot at or near a target site, one can relieve pain caused by diverse sources, including but not limited to spinal disc herniation (i.e. sciatica), spondilothesis, stenosis, discogenic back pain and joint pain. When appropriate drug depot formulations are provided within biodegradable polymers, this pain relief can be continued for at least fourteen days.

Clonidine compounds in a biodegradable polymer

Methods of preparing compositions for preferential distribution of active agents to injury sites are provided. The compositions may comprise a polymer with hydrophilic properties and one or more active agents, such as compounds comprising hydrophilic metal ions. Because the delivery ligand and the active agent are specifically selected so the interactions between them are mainly of an ionic nature. Methods of identifying suitable components for such compositions are also disclosed.

Methods of identifying potential components for targeted drug delivery compositions

The invention provides a method for alleviating discogenic pain by administering a therapeutic agent that disrupts neuronal and/or vascular elements in the disc, which is typically a degenerated disc. Disruption of neuronal elements in the disk includes destroying nerve endings without substantially affecting the central body of the nerve, suppressing activation of the nerve endings, and inhibiting the growth of nerve endings into the disk. Disruption of vascular elements includes causing the vascular extensions to retract from the disk, or suppressing the formation of such extensions. The therapeutic agent may be administered locally via an interbody pump, a bolus or a depot, or may be administered systemically.

Methods for treating back or neck pain caused by NGF using a therapeutic agent comprising REN-1820, ALE-0540 and capsaicin

The invention provides methods and composition developed to be used with imaging techniques and useful for diagnosis and monitoring the pain generator(s) of axial pain with or without radiculopathy and methods for screening therapeutic compounds potentially useful for treating axial pain with or without radiculopathy. Alternatively, degenerated discs can be monitored and treated before occurrence of a pathological pain condition. Pain markers and markers of degeneration include markers of neuronal, vascular, immune and matrix elements.

Compostions and methods for diagnosis of axial pain with or without radiculopathy

Effective treatments of pain for extended periods of time are provided. Through the administration of an effective amount of clonidine and a gamma-aminobutyric acid compound at or near a target site, one can relieve pain caused by diverse sources, including but not limited to spinal disc herniation (i.e. sciatica), spondilothesis, stenosis, discogenic back pain and joint pain, as well as pain that is incidental to surgery. When appropriate formulations are provided within biodegradable polymers, this relief can be continued for at least three days. In some embodiments, the relief can be for at least twenty-five days, at least fifty days, at least one hundred days, at least one hundred and thirty-five days or at least one hundred and eighty days.

Clonidine and GABA compounds in a biodegradable polymer carrier

The invention provides compositions, kits, and methods for treatment of neuronal injury. In one embodiment, the composition comprises a biomembrane sealing agent, such as PEG, and a bioactive agent, such as a magnesium compound. The biomembrane sealing agent and/or the bioactive agent an intravenous administration, an intramuscular administration, an intrathecal administration, a subcutaneous administration, an epidural administration, a parenteral administration, a direct application onto or adjacent to a site of the pathological condition, and any combinations thereof. Alternatively, the biomembrane sealing agent and/or the bioactive agent may be delivered from a pump or an implant.

Compositions comprising biomembrane sealing agent for treatment of neuronal injury, and methods of use

Methods for treating back or neck pain caused by NGF using a therapeutic agent consisting of ReN-1820, ALE-0540 and capsaicin

Compositions and methods for diagnosis of axial pain with or without radiculopathy

Disclosed are compositions and methods for the preservation, storage, and transport of living biological tissues, organs, and populations of isolated cells. In particular, the disclosed compositions and processes permit mammalian cells, tissues, and organs to be harvested from suitable donor animals, stored for prolonged periods, and transported to the site of recipient implantation, all without significant loss of cell viability, biological activity, and/or tissue integrity.

Compositions and methods for enhancing the viability of animal cells, tissues, and organ explants

Pharmaceutical removal of neuronal extensions from a degenerating disc

The invention provides methods and kits for treatment of pain or inflammation. In one embodiment, the kit comprises a biomembrane sealing agent, such as PEG, and a bioactive agent, such as a magnesium compound. The biomembrane sealing agent and/or the bioactive agent an intravenous administration, an intramuscular administration, an intrathecal administration, a subcutaneous administration, an epidural administration, a parenteral administration, an intra-articular administration, a direct application onto or adjacent to a site of the pathological condition, and any combinations thereof. Alternatively, the biomembrane sealing agent and/or the bioactive agent may be delivered from a pump or an implant.

Method of treating traumatic brain or spinal cord injury with biomembrane sealing agent and magnesium compounds

In the present invention, Applicants demonstrate the effect of a biomembrane sealing agent on the development of chronic pain following tissue injury as well as acute pain in a model of acute inflammation. Applicants demonstrate the ability of this class of agents referred to as 'biomembrane sealing agents' to reduce the severity of hyperalgesia and allodynia following mechanical insult to the nervous system as well as their ability to reduce acute pain in a model of acute inflammation. Applicant describes the use of injectable or depot formulations of biomembrane sealing agent(s) for prophylactic treatment such as they could be administered after the insult (i.e. post-injury or post-surgery) but before the onset of acute or chronic pain. Alternatively, biomembrane sealing agents could be used to reduce the severity of acute or chronic pain after onset.

Compositions and methods for treating pain

Compositions are provided for preferential distribution of active agents to injury sites. Such compositions may comprise a ligand with hydrophilic properties and one or more active agents, such as compounds comprising hydrophilic metal ions. Because the delivery ligand and the active agent are specifically selected so the interactions between them are mainly of an ionic nature so that binding of the active agent to the delivery ligand and release of the active agent into the target site are not dependent on enzymatic activity. Methods of using such compositions are also disclosed.

Compositions and methods for preferential distribution of active agents to injury sites

Methods of treating hemorrhage are provided, comprising diagnosing one or more hemorrhaging or potentially hemorrhaging vessels in a patient and administering to the patient a therapeutically effective amount of a composition comprising a vessel closing compound at a concentration between about 0.1% and about 45%. The vessel closing compound may comprise a polymer with hydrophilic properties, such as polyethylene glycol (PEG). The composition may also comprise one or more active agent such as a blood flow modifier with a potential to form ionic bonds with the vessel closing agent.

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Memphis, TN, United States of America

Josee Roy