Abstract: The present disclosure relates to methods of treating pain, fibromyalgia, neuropathy, chemotherapy-induced pain, promoting an antihyperalgesic effect, and reducing sensitivity to pain, in a subject in need of such treatment comprising the administration of a therapeutically effective amount of Compound I, or a pharmaceutically acceptable salt, solvate, or prodrug thereof.

Abstract: This disclosure relates to gastro-resistant, controlled release dosage forms comprising Compound (I): or a pharmaceutically acceptable salt and/or solvate thereof, the pharmacokinetic properties of these dosage forms, and the preparation of the same. The novel dosage forms disclosed herein are useful in reducing the risk of QT prolongation in a subject and in treating a disorder in a subject in need thereof, e.g., a subject diagnosed with schizophrenia, for example, in treating the negative symptoms in a subject diagnosed with schizophrenia having the CYP2D6 EM genotype.

Abstract: The present application relates to the use of roluperidone, i.e., Compound (I): and salts, solvates, pharmaceutical compositions, and dosage forms thereof, for use in methods of treating negative symptoms and disorders (e.g., autism disorders, amblyopia, personality disorders, traumatic brain injury), as well as increasing neuroplasticity and promoting neuroprotection in subjects in need thereof.

Abstract: The disclosure provides a novel polymorph of Compound (I): 2-((1-(2-(4-Fluorophenyl)-2-oxoethyl)piperidin-4-yl)methyl)isoindolin-1-one monohydrochloride dihydrate, i.e., Form (A) of Compound (I).HCl.2H2O. Pharmaceutical compositions comprising Form (A) of Compound (I).HCl.2H2O and related methods of treatment are also disclosed.

Abstract: Disclosed herein are compositions and methods for treating depression using compositions comprising a compound of formula I. Disclosed herein are compositions and methods for treating depression using compositions comprising phenoxypropylamine compounds and derivatives having selective affinity for and antagonistic activity against the 5-HT1A receptor, as well as 5-HT reuptake inhibitory activity. In addition, compositions and methods for treating depression using compositions comprising a compound of formula II are disclosed. Methods of treating or diminishing at least one symptom of depression in a human subject with a composition comprising a compound of the formula (I) or formula (II), or a pharmaceutically acceptable salt, hydrate, or solvate thereof, are also disclosed.

Abstract: The disclosure provides a novel polymorph of Compound (I): 2-((1-(2-(4-Fluorophenyl)-2-oxoethyl)piperidin-4-yl)methyl)isoindolin-1-one monohydrochloride dihydrate, i.e., Form (A) of Compound (I).HCl.2H2O. Pharmaceutical compositions comprising Form (A) of Compound (I).HCl.2H2O and related methods of treatment are also disclosed.

Abstract: Disclosed herein are compositions and methods for treating schizophrenia and symptoms of schizophrenia, including negative symptoms of schizophrenia.

Abstract: The disclosure provides a novel polymorph of Compound (I): 2-((1-(2-(4-Fluorophenyl)-2-oxoethyl)piperidin-4-yl) methyl)isoindolin-1-one monohydrochloride dihydrate, i.e., Form (A) of Compound (I)•HC1•2H2O. Pharmaceutical compositions comprising Form (A) of Compound (I)•HC1•2H2O and related methods of treatment are also disclosed.

Abstract: The disclosure provides a novel polymorph of Compound (I): 2-((1-(2-(4-Fluorophenyl)-2-oxoethyl)piperidin-4-yl)methyl)isoindolin-1-one monohydrochloride dihydrate, i.e., Form (A) of Compound (I).HCl.2H2O. Pharmaceutical compositions comprising Form (A) of Compound (I).HCl.2H2O and related methods of treatment are also disclosed.

Abstract: Disclosed herein are compositions and methods for treating depression using compositions comprising a compound of formula I. Disclosed herein are compositions and methods for treating depression using compositions comprising phenoxypropylamine compounds and derivatives having selective affinity for and antagonistic activity against the 5-HT1A receptor, as well as 5-HT reuptake inhibitory activity. In addition, compositions and methods for treating depression using compositions comprising a compound of formula II are disclosed. Methods of treating or diminishing at least one symptom of depression in a human subject with a composition comprising a compound of the formula (I) or formula (II), or a pharmaceutically acceptable salt, hydrate, or solvate thereof, are also disclosed.