Collegium Pharmaceutical, Inc.

Health Solutions, L.l.c.

Michael Heffernan

Roman V Rariy

Jane C Hirsh

Srinivas G Rao

Shubha Chungi

Michael A Rothman

Timothy Manning Swager

Stephen L Buchwald

Dixon Newbold

Pharmaceutical compositions are provided for the pharmacological treatment of breathing disorders and, more specifically, to compositions containing agents having serotonin receptor modulating activity for the alleviation of sleep apnea (central and obstructive) and other sleep-related breathing disorders wherein the active ingredients are released such as to extend effective blood plasma concentrations across the period of sleep.

Pharmaceutical compositions for sleep disorders

A milnacipran formulation that provides delayed and extended release of milnacipran has been developed. The formulation comprises milnacipran or a salt thereof; an extended release excipient, and a delayed release excipient. The formulation provides, upon administration to a human subject, a Tof 4-10 hours.

Modified release compositions of milnacipran

The present invention relates generally to the enantiomers of para-hydroxy-milnacipran or congeners thereof. Biological assays revealed that racemic para-hydroxy-milnacipran is approximately equipotent in inhibiting serotonin and norepinephrine uptake (IC=28.6 nM for norepinephrine, IC=21.7 nM for serotonin). Interestingly, (+)-para-hydroxy-milnacipran is a more potent inhibitor of norepinephrine uptake than serotonin uptake (IC=10.3 nM for norepinephrine, IC=22 nM for serotonin). In contrast, (&#x2212;)-para-hydroxy-milnacipran is a more potent inhibitor of serotonin uptake compared to norepinephrin uptake (IC=88.5 nM for norepinephrine, IC=40.3 nM for serotonin). The invention also relates to salts and prodrug forms of the aforementioned compounds. In certain embodiments, the compounds of the present invention and a pharmaceutically acceptable excipient are combined to prepare a formulation for administration to a patient. Finally, the present invention relates to methods of treating mammals suffering from various afflictions, e.g., depression, chronic pain, or fibromyalgia, comprising administering to a mammal in need thereof a therapeutically effective amount of a compound of the present invention.

Stereoisomers of p-hydroxy-milnacipran, and methods of use thereof

A device and method for encouraging proper timing compliance in accordance with a medication prescription regimen. The device is preprogrammed so as to be tailored for the particular prescription regimen to be complied with. Appropriate circuitry is provided in order to generate a dosage signal, which dosage signal persists and changes in an easily recognizable manner until compliance with that dosage requirement is indicated by interacting with the device. Also included is circuitry for prompting compliance with refill requirements of the prescription. The device includes a casing which can have members for facilitating stand-up display or hang-up display of the device.

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Hingham, MA, United States of America

Michael Heffernan