Minerva Neurosciences, Inc.

Nadine Noel

Masahiro Okuyama

Remy Henri Luthringer

Sandra Werner

Jay Saoud

Emmanuelle Georgi

Hans Maag

Florent Schmitt

Remy Luthringer

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.

Gastro-resistant controlled release oral dosage forms

The present disclosure relates to compounds of Formula (I): and their prodrugs, solvates, pharmaceutically acceptable salts, pharmaceutical compositions, methods of use, and methods of their preparation. The compounds disclosed herein are useful for modulating Sigma receptors and have antiviral activity, and may also be useful in the treatment and/or prevention of pain disorders, neurological disorders (e.g., Parkinson's disease and Alzheimer's disease), and cancer.

Sigma ligand compounds and uses thereof

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.

Methods of using a phenoxypropylamine compound to treat pain

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.2HO. Pharmaceutical compositions comprising Form (A) of Compound (I).HCl.2HO and related methods of treatment are also disclosed.

Compositions and methods for treating schizophrenia

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)&#x2022;HC1&#x2022;2HO. Pharmaceutical compositions comprising Form (A) of Compound (I)&#x2022;HC1&#x2022;2HO and related methods of treatment are also disclosed.

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Gildwiller, France

Nadine Noel