Abstract: Disclosed are methods and compositions for the treatment of autism spectrum disorder, related disorders and symptoms of such disorders, comprising co-administration of an oxytocin peptide and magnesium ions. Co-administration of an oxytocin peptide and magnesium ions results in a synergistic or enhanced effect on reducing social and communication deficits in a patient suffering from an autism spectrum disorder.

Abstract: The present invention relates to crystalline forms of carbetocin, a method of their manufacture, and pharmaceutical compositions thereof.

Abstract: Disclosed are oxytocin compositions having a therapeutically effective amount of oxytocin, an analog or derivative of oxytocin, or an oxytocin receptor agonist for the treatment of neonatal abstinence syndrome (“NAS”) in a subject. Also disclosed are methods for the treatment of NAS by administering a therapeutically effective amount of oxytocin, an analog or derivative of oxytocin, or an oxytocin receptor agonist to a subject.

Abstract: Provided are methods and compositions for treatment of tinnitus. The method comprises administration of therapeutically effective amount of oxytocin, which may be present with a thickener, and may be delivered to the back of the nasal cavity in a suitable form. Compositions of oxytocin for intranasal delivery and sprayable unit compositions of oxytocin are also provided.

Abstract: The present disclosure includes a method of making an improved carbetocin drug product. The disclosed method for making an improved carbetocin drug product comprises agitating a carbetocin preparation containing an aqueous solution of carbetocin and one or more excipients for a period of time to initiate the formation of aggregate-forming solids and filtering off the aggregates that form before further processing the remaining carbetocin into a final drug product. The present disclosure also relates to an improved carbetocin drug product, wherein the drug product is substantially free of aggregate-forming solids. The disclosed carbetocin drug product can be used for the treatment of a neurodevelopmental disorder, such as Präder-Willi syndrome. Additionally, the disclosed carbetocin drug product shows content uniformity of carbetocin over long periods of time before and after one or more freeze/thaw cycles, provides enhanced convenience and patient compliance, and/or are highly concentrated.

Abstract: The application describes stable aqueous compositions comprising relatively high concentrations of carbetocin and a solubilizer and/or surface active agent. The disclosed carbetocin compositions are effective in the treatment of a neurodevelopmental disorder, such as Präder-Willi syndrome. Additionally, the disclosed carbetocin compositions show improved stability at room temperature and/or under accelerated conditions of stress.

Abstract: Provided herein are peptide formulations comprising polymers as stabilizing agents. The peptide formulations can be more stable for prolonged periods of time at temperatures higher than room temperature when formulated with the polymers. The polymers used in the present invention can decrease the degradation of the constituent peptides of the peptide formulations.

Abstract: Provided herein are peptide formulations comprising polymers as stabilizing agents. The peptide formulations can be more stable for prolonged periods of time at temperatures higher than room temperature when formulated with the polymers. The polymers used in the present invention can decrease the degradation of the constituent peptides of the peptide formulations.

Abstract: Provided herein are peptide formulations comprising polymers as stabilizing agents. The peptide formulations can be more stable for prolonged periods of time at temperatures higher than room temperature when formulated with the polymers. The polymers used in the present invention can decrease the degradation of the constituent peptides of the peptide formulations.

Abstract: Provided herein are peptide formulations comprising polymers as stabilizing agents. The peptide formulations can be more stable for prolonged periods of time at temperatures higher than room temperature when formulated with the polymers. The polymers used in the present invention can decrease the degradation of the constituent peptides of the peptide formulations.

Abstract: A nasal delivery device for and method of delivering a substance, preferably comprising oxytocin, non-peptide agonists thereof and antagonists thereof, preferably as one of a liquid, as a suspension or solution, or a powder to the nasal airway of a subject, preferably the posterior region of the nasal airway, and preferably the upper posterior region of the nasal airway which includes the olfactory bulb and the trigeminal nerve, and preferably in the treatment of neurological conditions and disorders.

Abstract: The present invention provides a method for preparing atosiban acetate. The method comprises the following steps of: synthesizing to obtain linear atosiban; dissolving the linear atosiban in an acetonitrile aqueous solution, adjusting the pH value with ammonia water, adding H2O2 for oxidizing, filtering, purifying, and transferring salt to obtain the atosiban acetate. In the present invention, an appropriate route is provided, the linear atosiban is synthesized by adopting a solid phase method, and the atosiban is obtained by liquid phase oxidation. The method has the advantages of capabilities of solving the problem of insolubility of the linear atosiban, reducing the reaction size to the maximum extent and shortening reaction time, and being high in yield and easy to industrialize.

Abstract: The present invention relates to a novel pharmaceutical composition comprising oxytocin and/or one or more fragment(s) and/or variant(s) thereof and at least one non-ionic cellulose ether, such as hydroxypropylmethylcellulose, said pharmaceutical composition having a low pH. The present pharmaceutical composition has been shown to provide an exceptionally suitable environment for oxytocin, as the stability thereof has increased significantly as compared to previous compositions with this molecule. The pharmaceutical composition according to the invention can be used for medical purposes, such as in the treatment of climacteric disorders.

Abstract: Methods and compositions containing oxytocin or an oxytocin analog, such as carbetocin, are provided for the prevention and treatment of autism spectrum disorders, related disorders and symptoms of such disorders. The methods and compositions of this disclosure are effective in the treatment of social withdrawal, eye contact avoidance, repetitive behaviors, anxiety, attention deficit, hyperactivity, depression, loss of speech, verbal communication difficulties, aversion to touch, visual difficulties, comprehension difficulties, and sound and light sensitivity. Additional compositions and methods are provided which employ oxytocin or an oxytocin analog in combination with a secondary or adjunctive therapeutic agent to yield more effective treatment tools against autism spectrum disorders and related disorders.

Abstract: The present invention refers to the use of certain sulfated glycosaminoglycans for treatment or prevention of postpartum haemorrhage. The sulfated glycosaminoglycans have a reduced anticoagulant activity and are administered in combination with at least one uterotonic agent capable of promoting myometrial contractions of the uterus and thereby compress the vessels and cease the bleeding.

Abstract: The present invention refers to the use of certain sulfated glycosaminoglycans for treatment of labor arrest. The sulfated glycosaminoglycans have a reduced anticoagulant activity and are administered in combination with an agent capable of promoting myometrial contractions of the uterus and thereby re-establish effective labor.

Abstract: This disclosure provides methods of using compounds that act to increase oxytocin release, including certain melanocortin receptor agonists, for treating or reducing the severity of psychotherapeutic or social disorders such as autism, and in particular the use of these compounds as an adjunct to psychotherapeutic counseling or behavioral therapy.

Abstract: The present invention relates to compositions and methods for transdermal drug delivery comprising formulating a phosphatidylcholine carrier composition containing the drug and applying the composition to the skin.

Abstract: The present invention relates to a compound which is an agonist of the oxytocin receptor o for use in the treatment of a feeding disorder with early-onset. In a particular embodiment, the agonist of the oxytocin receptor is the oxytocin or an active fragment thereof.

Abstract: This invention relates to drug delivery and in particular to the delivery of biologically active agents in the form of dry powders for inhalation. The invention also relates to methods for preparing such dry powder formulations and methods for their use.

Abstract: The present invention relates to a novel pharmaceutical composition comprising oxytocin and/or one or more fragment(s) and/or variant(s) thereof and at least one non-ionic cellulose ether, such as hydroxypropylmethylcellulose, said pharmaceutical composition having a low pH. The present pharmaceutical composition has been shown to provide an exceptionally suitable environment for oxytocin, as the stability thereof has increased significantly as compared to previous compositions with this molecule. The pharmaceutical composition according to the invention can be used for medical purposes, such as in the treatment of climacteric disorders.

Abstract: As disclosed herein, novel compositions including steroid hormones, such as trimegestone (TMG) and progesterone (P4), provide treatments for term and preterm labor with significant effects on the delay of delivery. Delay and block of delivery occurs when both P4 and TMG are administered late in gestation in pregnant rat and guinea pig animal models. TMG exhibits remarkable drug efficacy, achieving the same inhibition as P4, but at much lower doses. These hereto unknown effects of TMG on the processes of cervical ripening and uterine contraction provide a novel approach for extending pregnancy term, including reducing a likelihood of preterm and/or term labor, along with improved methods of administration. Other diseases and/or conditions may be treated with TMG, such as dysmenorrhea or luteal insufficiency for sustaining pregnancy.

Abstract: A method for preparing polymer microparticles with a reduced initial burst, and the polymer microparticles prepared thereby, the method including: contacting polymer microparticles with an alcohol aqueous solution, the polymer microparticles prepared thereby, and use for drug delivery of the polymer microparticles.

Abstract: A nasal delivery device for and method of delivering a substance, preferably comprising oxytocin, non-peptide agonists thereof and antagonists thereof, preferably as one of a liquid, as a suspension or solution, or a powder, to the nasal airway of a subject, preferably the posterior region of the nasal airway, and preferably the upper posterior region of the nasal airway which includes the olfactory bulb and the trigeminal nerve, and preferably in the treatment of neurological conditions and disorders.

Abstract: The present invention relates to compositions and methods for transdermal drug delivery comprising formulating a phosphatidylcholine carrier composition containing the drug and applying the composition to the skin.

Abstract: A method of delivering a drug composition comprises providing a carrier having a phosphatidylcholine component and a drug entrapped therein, and applying the composition to the skin for transdermal delivery of the drug, wherein the composition is stable at room temperature.

Abstract: A pharmaceutical controlled release composition in solid dosage form is provided which comprises (I) a water-swell able linear polymer obtainable by reacting together: (a) a polyethylene oxide; (b) a C5 to C20 diol; and (c) a diisocyanate; and (II) a releasable pharmaceutically active agent.

Abstract: The disclosure provides a method for enhancing memory of a subject, lowering blood glucose levels in a subject, and treating schizophrenia, the methods comprise intranasally administering to the subject an amount of a oxytocin peptide or analogue thereof having a beneficial effect.

Abstract: The present invention relates to methods for the treatment of headache and headache disorders. The methods comprise administration of an oxytocin peptide for the treatment of primary and secondary headaches or trigeminal neuralgia.

Abstract: Peptide analogues of oxytocin are described together with methods of treating conditions ameliorated by modulating oxytocin receptor. The peptide analogues are seleno or telluro peptide analogues. Methods of synthesis of selenocysteine, tellurocysteine and oxytocin analogues are also described.

Abstract: The invention discloses a pharmaceutical composition containing oxytocin and melatonin in amounts therapeutically effective for inducing labor in a pregnant human patient. Preferably, the oxytocin content is reduced to mitigate unwanted side effects and the melatonin content synergistically enhances the oxytocin's labor-inducing effectiveness. Also disclosed is a pharmaceutical composition for treatment of a pregnant human patient experiencing pre-term labor characterized by early expression of melatonin receptors in myometrial cells, the composition containing one or more agents which interfere with melatonin binding to said receptors.

Abstract: The present invention is directed to a derivative selected from oxytocin, an oxytocin derivative, and an oxytocin agonist useful for the treatment of a disorder selected from obesity and insulin resistance and related methods and pharmaceutical formulations. In particular, the invention relates to a derivative selected from oxytocin, an oxytocin derivative, and an oxytocin agonist useful in the treatment of metabolic syndrome.

Abstract: The invention provides a method of treating a psychiatric or medical disorder in a mammalian subject, the method comprising administering to the subject an effective amount of an oxytocin receptor agonist (e.g., oxytocin). Optionally, the oxytocin receptor agonist is delivered by intranasal administration. Further provided is a method of increasing social cognition, increasing social functioning, increasing empathy, increasing trust of others, reducing paranoia and/or reducing hostility in a subject with a psychotic disorder, a mood disorder characterized by psychotic features, a personality disorder or a pervasive developmental disorder, the method comprising administering to the subject an effective amount of an oxytocin receptor agonist.

Abstract: The present invention relates to methods for the treatment of headache and headache disorders. The methods comprise administration of an oxytocin peptide for the treatment of primary and secondary headaches or trigeminal neuralgia.

Abstract: The present invention provides methods for the therapy and prevention of problem drinking in alcohol-dependent and non-dependent subjects and those at risk of developing problem drinking behavior, and compositions of matter comprising oxytocin or an analog or derivative thereof or an agonist or partial agonist of an oxytocin receptor that are useful in preventing or treating problem drinking.

Abstract: The invention discloses particulate complexes composed of chitosan, poly-glutamic acid, and at least one bioactive agent, wherein equal moles of the positively charged chitosan and the negatively charged poly-glutamic acid substrate form an electrostatic network enabling improved loading the bioactive agent.

Abstract: The present invention relates to methods of treating for treating stuttering or other speech impediments that are not related to psychiatric disorders or autism using oxytocin or its analogs.

Abstract: The present invention provides methods of forming a solid, biodegradable implant in-situ in a body by administering a liquid pharmaceutical composition comprising an effective amount of a biocompatible, water-insoluble, biodegradable polymer and an effective amount of a therapeutic peptide covalently modified with one or more lipophilic or amphiphilic moieties, which are dissolved or dispersed in a biocompatible, water-soluble organic solvent. This invention also provides related compositions and methods.

Abstract: The present invention relates to methods for the treatment or prevention of trigeminal nerve-associated pain, in particular chronic, acute and procedural-related pain. The methods comprise administration of analgesic agents to the trigeminal nerve system which results in analgesia to the facial or head region.

Abstract: The present invention relates to methods for the treatment of headache and headache disorders. The methods comprise administration of an oxytocin peptide for the treatment of primary and secondary headaches or trigeminal neuralgia.

Abstract: The present invention relates to oxytocin receptor agonist compounds, pharmaceutical compositions comprising the same, use of such compounds for the manufacture of a medicament for treatment of inter alia, abdominal pain, irritable bowel syndrome (IBS), autism, erectile dysfunction, female sexual dysfunction, labor induction and maintenance, lactation induction and maintenance, postpartum hemorrhage, Post Traumatic Stress Disorder (PTSD), pain, anxiety and other conditions, as well as to methods for the treatment of such conditions, wherein such compounds are administered.

Abstract: The present invention relates to the use of novel compounds for the manufacture of a medicament for treatment of, inter alia, conditions associated with critical care sepsis, septic shock, hepatorenal syndrome type I, hypertension induced by endstage venal disease, severe burns, thermal injury as well as to a method for treatment of the conditions by administering the compounds. The compounds used are represented by the general formula (1), as further defined in the specification.

Abstract: The present invention describes a method of inducing lactation in non-human mammals by using a single administrations of an estrogen compound, a dopaminergic antagonist, and oxytocin. For example, the estrogen compound may be a long acting composition and is administered at least one week before the dopaminergic antagonist. However, the oxytocin administration may be given the day after the dopaminergic antagonist, after which lactation may begin immediately. Preferred compounds may comprise a non-17? estradiol and domperidone. Such an injection protocol has resulted in the production of commercially viable volumes of milk from transgenic pigs.

Abstract: Methods and compositions containing oxytocin or an oxytocin analog, such as carbetocin, are provided for the prevention and treatment of autism spectrum disorders, related disorders and symptoms of such disorders. The methods and compositions of this disclosure are effective in the treatment of social withdrawal, eye contact avoidance, repetitive behaviors, anxiety, attention deficit, hyperactivity, depression, loss of speech, verbal communication difficulties, aversion to touch, visual difficulties, comprehension difficulties, and sound and light sensitivity. Additional compositions and methods are provided which employ oxytocin or an oxytocin analog in combination with a secondary or adjunctive therapeutic agent to yield more effective treatment tools against autism spectrum disorders and related disorders.

Abstract: Nano-sized particles are provided comprising at least one multi-headed amphiphilic compound, in which at least one headgroup of said multi-headed amphiphilic compound is selectively cleavable or contains a selectively cleavable group, and at least one biologically active agent, which is both encapsulated within the nano-particle and non-covalently associated thereto.

Abstract: The present invention relates to methods for the treatment of headache and headache disorders. The methods comprise administration of an oxytocin peptide for the treatment of primary and secondary headaches or trigeminal neuralgia.

Abstract: The present invention relates to methods for the treatment of headache and headache disorders. The methods comprise administration of an oxytocin peptide for the treatment of primary and secondary headaches or trigeminal neuralgia.

Abstract: Methods for treating neurodegenerative disorders, including Parkinson's disease, are provided. The methods comprise administrating a therapeutically effective amount of oxytocin or oxytocin analogs to alleviate one or more symptoms of Parkinson's disease. Methods for determining the effectiveness of oxytocin therapy by itself or in addition to one or more adjunctive therapies in alleviating one or more symptoms of Parkinson's disease are also discussed.

Abstract: The present invention relates biomedically useful compositions containing bioactive agents and biodegradable carbohydrate polyethers that exhibit reverse thermogelation properties in aqueous media. The microstructure structure and properties of the carbohydrate polyethers can be conveniently controlled with respect to functionality, molecular weight, polydispersity index, microstructure and tertiary structure, they can be customized for use in a variety of biomedical applications including drug delivery, cell delivery, surgical procedures and the like.

Abstract: The invention described herein provides an oral solid transmucosal dosage form that enhances transmucosal permeation of biologically active polypeptides across oral mucosal tissue and provides relatively rapid efficacious therapeutic onset thereof. Dosage forms prepared according to the invention can enhance transmucosal absorption of polypeptides in therapeutic serum concentrations to the recipient. The invention provides a solid dosage form for oral transmucosal absorption of a biologically active polypeptide, wherein the dosage form comprises a pharmaceutical composition comprising: a therapeutically active polypeptide; a bile salt; and an effervescent excipient component, which can comprise an effervescent couple and optionally a pH adjusting substance. The invention includes a method of administering a biologically active polypeptide, as well as a method of enhancing transmucosal absorption of a biologically active polypeptide.