OBJECTIVES The atypical antipsychotic quetiapine is a first-line treatment for schizophrenia. This non-interventional study (NCT01212575) evaluated the clinical use of its two formulations, extended release (XR) and immediate release (IR), in outpatients with schizophrenia spectrum disorder. METHODS Patients who had received at least one dose of quetiapine XR and/or IR were included. A dosage...

OBJECTIVE To determine the impact of immediate release Ritalin, given three times a day, on sleep quality and quantity in medication-naïve, newly diagnosed children with attention-deficit/hyperactivity disorder (ADHD). METHODS Children (aged 6-12) rigorously diagnosed with ADHD (n = 21) underwent multiple measurement assessments (i.e., actigraphy, sleep diary, and questionnaires) during a 1-w...

On 14 th March, 2006, The Road to Guantánamo (Whitecross, 1 Winterbottom) became the first film ever to be released simultaneously in cinemas, on broadcast television, on DVD and over the internet for streaming or downloading. This unprecedented adoption of a „day-date‟ release schedule by the film‟s British distributor is a sign that, as a consequence of shifts in film-viewing practices, the c...

Ropinirole is a dopamine agonist, approved for use to treat symptoms of early and advanced Parkinson's disease, is now available in a 24-hour formulation in addition to the immediate release version. This review discusses the mode of action of ropinirole and compares the pharmacokinetics of both formulations. Pivotal studies leading to the approval of both preparations are reviewed in terms of ...

The combined peak U.S. annual sales potential (excluding disease modification) for the PD indications alone is estimated to be in the range of $1.8bn to $2.7bn , (source Michael J Fox Foundation 2011). Datamonitor market research with PD specialists in the U.S., EU, China and India show that dipraglurant has an attractive product profile and can capture over $1 billion in annual revenues if ful...

Extended-release (XR) formulations enable less frequent dosing vs. conventional (e.g., immediate release (IR)) formulations. Regulatory registration of such formulations typically requires pharmacokinetic (PK) and clinical efficacy data. Here we illustrate a model-informed, exposure-response (E-R) approach to translate controlled trial data from one formulation to another without a phase III tr...

Melatonin is increasingly used for the treatment of sleep disorders. Surge-sustained formulations consisting of combined immediate release and controlled release dosing may mimic the endogenous melatonin physiologic profile. However, relatively little is known about the pharmacokinetic properties of low-dose (<0.5mg) and high-dose (>2mg) melatonin in a combined immediate release/controlled rele...