Purdue Pharma L.P.

The invention relates to tinostamustine for use in the treatment of multiple myeloma. Tinostamustine may cause side effects when administered to a patient, and it is desirable to minimise such effects. The present invention defines an improved treatment, wherein the dose of tinostamustine administered is varied based on the patient's platelet count.

There is provided tinostamustine or a pharmaceutically acceptable salt thereof for use in the treatment of T-cell prolymphocytic leukemia (T-PLL) in a patient in need thereof.

Disclosed in certain embodiments is a method of treating or preventing an opioid-induced adverse pharmacodynamic response comprising administering to a patient in need thereof an effective amount of buprenorphine.

In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.

Provided herein are novel crystalline forms of a crystalline compound of Formula (I), which modulates the ORL-1 receptor. The crystalline compounds of Formula (1), compositions thereof, and methods of using thereof that are described herein are particularly useful for treatment, prevention, and management of several sleep disorders.

There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.

The disclosure relates to methods for treating or preventing a sleep disorder by administering a compound of formula (1) (1), or a compound of formula (1A), (1B), (1C), (1D)), (1E), or (1F) to an animal in need of such treatment. In certain embodiments, such compounds effectively treat or prevent a sleep disorder in the animal, while producing reduced side effects compared to previously available compounds.

The disclosure provides a method of treating or preventing overactive bladder syndrome (OBS) in a human subject (with normal renal function, mild renal impairment, or mild to moderate renal impairment) in need of such treatment, comprising administering to the human subject a therapeutically effective amount of a compound of the formula (I) or a pharmaceutically acceptable salt thereof. In one embodiment, the method comprises administering the compound of formula (IA).

There is provided tinostamustine or a pharmaceutically acceptable salt thereof for use in the treatment of sarcoma in a patient in need thereof.

Disclosed in certain embodiments is a solid oral dosage form comprising a heat-labile gelling agent; a thermal stabilizer; and a drug susceptible to abuse.