Disclosed herein are compositions for supporting bladder health and/or treating, ameliorating, preventing, or reducing overactive bladder or the symptoms associated therewith. The compositions disclosed herein comprise a beta-adrenergic receptor agonist and at least one muscarinic receptor antagonist. Also described herein are methods utilizing the aforementioned compositions.

Disclosed herein are compositions for supporting bladder health and/or treating, ameliorating, preventing, or reducing overactive bladder or the symptoms associated therewith. The compositions disclosed herein comprise a beta-adrenergic receptor agonist and at least one muscarinic receptor antagonist. Also described herein are methods utilizing the aforementioned compositions.

Embodiments of the present invention are directed to a plurality of substantially spherical microspheres comprising at least one API substantially dispersed in at least one polymer and a lyoprotectant on an outside surface of the plurality of substantially spherical microspheres, wherein the plurality of substantially spherical microspheres have a D99[num] particle diameter of less than about 10 m; a D90[num] circularity value of from about 0.8 to about 1.0; and comprise API in a weight of about 20 to about 40 wt. % of the polymer. Other embodiments relate to injectable compositions comprising such microspheres and methods of treating a number of conditions by administering such injectable compositions to a subject.

Compounds and methods for treating diseases mediated by a P2X.sub.3 and/or a P2X.sub.2/3 receptor antagonist, the methods comprising administering to a subject in need thereof an effective amount of a compound of formula (I):

##STR00001##

or a pharmaceutically acceptable salt, solvate or prodrug thereof, wherein X is O, D, Y, R.sup.1, R.sup.2, R.sup.3, R.sup.4, R.sup.5, R.sup.6, R.sup.1 and R.sup.8 are as defined herein.

The present invention provides co-crystals of glycopyrronium bromide with lactose. The glycopyrronium bromide and lactose in the novel co-crystals are present in a stoichiometric ratio of from about 1:2 to 2:1. These are characterized by XRD and DSC. Processes for preparing the novel co-crystals are also provided. The co-crystals are also disclosed for use as a medicament, in particular, for treatment of respiratory complaints, such as chronic pulmonary obstructive disease (COPD), bronchitis and asthma. Pharmaceutical compositions comprising the co-crystals as active ingredient are also presented.

Compounds and methods for treating diseases mediated by a P2X.sub.3 and/or a P2X.sub.2/3 receptor antagonist, the methods comprising administering to a subject in need thereof an effective amount of a compound of formula (I):

##STR00001##

or a pharmaceutically acceptable salt, solvate or prodrug thereof, wherein X is O, D, Y, R.sup.1, R.sup.2, R.sup.3, R.sup.4, R.sup.5, R.sup.6, R.sup.7 and R.sup.8 are as defined herein.

Sustained release oral dosage forms of a gabapentin prodrug, 1-{[-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane acetic acid, are disclosed. The dosage forms are useful for treating or preventing diseases and disorders for which gabapentin is therapeutically effective.

Provided herein are 3,3-disubstituted 19-nor-steroidal compounds according to Formula (I): and pharmaceutical compositions thereof. Such compounds are contemplated useful for the prevention and treatment of a variety of CNS-related conditions, for example, treatment of sleep disorders, mood disorders, schizophrenia spectrum disorders, disorders of memory and/or cognition, movement disorders, personality disorders, autism spectrum disorders, pain, traumatic brain injury, vascular diseases, substance abuse disorders and/or withdrawal syndromes, tinnitus, and status epilepticus. ##STR00001##

Compositions and methods for treating one or more symptoms one or more symptoms such as reduced sexual desire and fecal compaction are provided. Accordingly, the disclosed composition can be administered to subjects in need thereof, including patients with multiple sclerosis, particularly in patients in which multiple sclerosis symptoms are exacerbated in the premenstrual time period/during the menstrual period. The compositions are unit dosage forms including pharmaceutically acceptable salts of a BPC peptide. The unit dosage forms can be formulated for enteral, parenteral, or topical administration. Also provided herein are methods of increasing sexual desire or reducing fecal compaction in a subject in need thereof. In one embodiment, the compositions disclosed herein are used to alleviate one or more symptoms in patients with multiple sclerosis, particularly in patients in which multiple sclerosis symptoms are exacerbated in the premenstrual time period. The disclosed dosage forms can be administered orally or parenterally.

Provided herein are 3,3-disubstituted 19-nor-steroidal compounds according to Formula (1): and pharmaceutical compositions thereof. Such compounds are contemplated useful for the prevention and treatment of a variety of CNS-related conditions, for example, treatment of sleep disorders, mood disorders, schizophrenia spectrum disorders, disorders of memory and/or cognition, movement disorders, personality disorders, autism spectrum disorders, pain, traumatic brain injury, vascular diseases, substance abuse disorders and/or withdrawal syndromes, tinnitus, and status epilepticus.

##STR00001##