Abstract: Methods of using botulinum toxin based pharmaceuticals are disclosed. The methods cause vasodilatation and decreased flow resistance of certain vascular beds for the purpose of increasing blood flow to a region in order to positively impact deterioration from a number of diseases.

Abstract: A pharmaceutical composition of botulinum toxin and an adjuvant is disclosed. The composition is formulated for topical administration to deliver a therapeutically effective dose of botulinum toxin to an area of a subject suffering from inflammation. The botulinum toxin composition reduces a symptom of inflammation without producing substantial muscle weakness. The composition may optionally contain additional anti-inflammatory agents, such as steroidal or non-steroidal agents.

Abstract: An extended duration pharmaceutical composition including a botulinum neurotoxin, an adhesive agent, and a stabilizing macromolecule. The composition effectively has all the properties to cause chemodenervation through a facial muscle, or other muscle, that predecessor botulinum toxin preparations have had as well as agents which create a fibrotic adhesion on the under surface of facial muscles (or other muscles) to the facial bone (or other bones) so that the facial bone tethers the under surface of the facial muscle, thereby causing fibrosis to the underlying fat pad. The composition can be used to treat various disorders. Methods of modifying facial contour for functional or cosmetic purposes in a human patient are disclosed which involve injecting a therapeutically effective amount of the disclosed compositions. A method of quantifying the extended duration of the compositions is also disclosed.

Abstract: The invention provides methods for treating primary disorders of mood and affect, including depressive disorders, anxiety and sleep disorders and CNS disorders comprising the administration of a neurotoxin.

Abstract: The present invention provides methods for treating sinus-evoked headaches using botulinum toxin injected or applied in multiple subcutaneous locations over divisions of the trigeminal nerve in soft tissues and dermatomes overlying the corresponding effected sinuses implicated in the etiology of the pain.

Abstract: The present invention provides improved formulations of botulinum toxin that increase delivery of the botulinum toxin to neural and associated tissues and exhibit a higher specific neurotoxicity and higher potency (in LD50 Units) than available formulations of botulinum toxins. These improved formulations enable physicians to treat a wide variety of pathological conditions with a lower toxin load that reduces the risk of inducing an immune response against the toxin and its associated proteins that may ultimately lead to the development of toxin resistance. These benefits are particularly important in the treatment of conditions that require high-dose or chronic administration of botulinum toxin. Additionally, the decreased in LD50 Unit doses of inventive formulations allows for controlled administration limits diffusion. The present invention also provides methods of treating neuromuscular diseases and pain, using low-dose botulinum toxin.

Abstract: This invention relates to a composition of botulinum based pharmaceuticals used for therapeutic and cosmetic treatment. This invention offers an improvement on the prior art by eliminating the potential of blood-borne contamination with botulinum based pharmaceuticals. Recombinant serum albumin is taught for use in the place of human serum albumin as a stabilizing or enhancing agent.

Abstract: Botulinum toxin, a well know systemic poison, produces favorable therapeutic effect by virtue of regionally attaching to nerves within the myoneural junction and possibly other tissues in a target region of a particular tissue. The present invention provides compositions of botulinum toxin and a sequestration agent that increase sequestration and delivery of the botulinum toxin to neural and associated tissues, as compared with available formulations of botulinum toxins, and thereby produce a beneficial clinical effect. The sequestration agents of the present invention include proteins, lipids and carbohydrates. A preferred composition of the present invention comprises a botulinum toxin and an albumin. The present invention also provides methods of treating neuromuscular diseases and pain using the disclosed compositions and methods of making the disclosed compositions.

Abstract: Devices, methods and kits are disclosed for preparing and administering less-painful formulations of Botulinum toxin. The devices, methods and kits of the present invention are comprised of or use an acidic formulation of Botulinum toxin, or, in certain embodiments, a freeze- or flash-dried composition of Botulinum toxin, having a long shelf-life which is subsequently mixed with an acid-neutralizing solution and, optionally a sequestration agent prior to administration to a patient in need thereof. The pH-neutralized formulation of Botulinum toxin is pharmaceutically acceptable for administration to a patient and is significantly less painful than acidic formulations of Botulinum toxin or formulations of Botulinum toxin having unnecessary antigens.

Abstract: An extended duration pharmaceutical composition including a botulinum neurotoxin, an adhesive agent, and a stabilizing macromolecule. The composition effectively has all the properties to cause chemodenervation through a facial muscle, or other muscle, that predecessor botulinum toxin preparations have had as well as agents which create a fibrotic adhesion on the under surface of facial muscles (or other muscles) to the facial bone (or other bones) so that the facial bone tethers the under surface of the facial muscle, thereby causing fibrosis to the underlying fat pad. The composition can be used to treat various disorders. Methods of modifying facial contour for functional or cosmetic purposes in a human patient are disclosed which involve injecting a therapeutically effective amount of the disclosed compositions. A method of quantifying the extended duration of the compositions is also disclosed.

Abstract: Chalazia and hordeola are the most common lesions occurring in the human eyelid, and often recurrences are managed by surgical intervention to remove fatty inclusions within the lid with associated inflammatory reaction. The present invention provides non-surgical methods of treating chalazia, hordeola and cutaneous infections comprising the administration of compositions comprising botulinum toxin. The present invention provides methods that effectively block meibum secretion from the meibomian glands, reduce sebaceous bacterial culture media on skin, and sebaceous secretion from the glands of Zeis. Decreased production of meibum and associated fatty substances resulting from the methods of the present invention, decrease gland blockage and tissue inspissations, resulting in reduced recurrence of chalazia, hordeola and related inflammatory reactions and lesions.

Abstract: The present invention provides improved formulations of botulinum toxin that increase delivery of the botulinum toxin to neural and associated tissues and exhibit a higher specific neurotoxicity and higher potency (in LD50 Units) than available formulations of botulinum toxins. These improved formulations enable physicians to treat a wide variety of pathological conditions with a lower toxin load that reduces the risk of inducing an immune response against the toxin and its associated proteins that may ultimately lead to the development of toxin resistance. These benefits are particularly important in the treatment of conditions that require high-dose or chronic administration of botulinum toxin. Additionally, the decreased in LD50 Unit doses of inventive formulations allows for controlled administration limits diffusion. The present invention also provides methods of treating neuromuscular diseases and pain, using low-dose botulinum toxin.

Abstract: Botulinum toxin has been shown to be useful for the treatment of pain when administered for cervical dystonia. Given efficacy for pain relief in regional dystonia, further expanded applications have included myofascial pain, muscle tension headaches, and other forms of headache syndromes. The application in headache practice has expanded to migraine as well as certain secondary headache syndromes. Although multiple case reports involving the use of botulinum toxin have shown promise in its utility for the treatment of primary pain syndromes, to date, controlled trials have failed to consistently and more definitively prove utility. Described herein is a method for selection of patients with headache syndromes more likely to respond to botulinum administration.

Abstract: Pharmaceutical application of a chemodenervating agent, particularly botulinum toxin, reduces inflammatory response and serves as an anti-inflammatory agent without systemic side effects and with long duration action, on the order of 12-24 weeks. In one embodiment, the effective dosage for allergy provoked inflammation reduction is an order of magnitude less than dosages associated with treatment of regional movement diseases, since the agent works to reduce inflammation by reducing histamine and other preformed mediator releases associated with mast cell degranulation.

Abstract: This invention relates to a composition of botulinum based pharmaceuticals used for therapeutic and cosmetic treatment. This invention offers an improvement on the prior art by eliminating the potential of blood-borne contamination with botulinum based pharmaceuticals. Recombinant serum albumin is taught for use in the place of human serum albumin as a stabilizing or enhancing agent.

Abstract: Chalazia and hordeola are the most common lesions occurring in the human eyelid, and often recurrences are managed by surgical intervention to remove fatty inclusions within the lid with associated inflammatory reaction. The present invention provides non-surgical methods of treating chalazia, hordeola and cutaneous infections comprising the administration of compositions comprising botulinum toxin. The present invention provides methods that effectively block meibum secretion from the meibomian glands, reduce sebaceous bacterial culture media on skin, and sebaceous secretion from the glands of Zeis. Decreased production of meibum and associated fatty substances resulting from the methods of the present invention, decrease gland blockage and tissue inspissations, resulting in reduced recurrence of chalazia, hordeola and related inflammatory reactions and lesions.

Abstract: Pharmaceutical applications of a chemodenervating agent reduce pain by altering release of pain and inflammation-mediating autocoids, with a duration of action between 12-24 weeks. The limiting factor in dosing for this application is weakness and paralysis created by higher doses of the chemodenervating pharmaceutical. This weakness and paralysis is mediated by action of the neurotoxin component of the chemodenervating pharmaceutical. The invention described herein represents a novel mechanism and pharmaceutical formulation which eliminates the neurotoxin component of the chemodenervating pharmaceutical, while retaining the cytotoxin component which provides an essential bioeffect for the relief of pain and inflammation. The invention allows for improvement in administering the pharmaceutical agent for the reduction of pain and/or inflammation without causing muscular weakness and paralysis.