Awareness and treatment of alcohol dependence in Japan: results from internet-based surveys in persons, family, physicians and society.

Aims: To understand current awareness of, and views on, treatment of alcohol dependence in Japan.

Methods: (a) Nationwide internet-based survey of 520 individuals, consisting of 52 diagnosed alcohol-dependent (AD) persons, 154 potentially alcohol-dependent (ADP) persons, 104 family members and 106 friends/colleagues of AD persons, and 104 general individuals, derived from a consumer panel where the response rate was 64.3%.

Drug reformulations and repositioning in the pharmaceutical industry and their impact on market access: regulatory implications.

Background: Repurposing has become a mainstream strategy in drug development, but it faces multiple challenges, amongst them the increasing and ever changing regulatory framework. This is the second study of a series of three-part publication project with the ultimate goal of understanding the market access rationale and conditions attributed to drug repurposing in the United States and in Europe. The aim of the current study to evaluate the regulatory path associated with each type of repurposing strategy according to the previously proposed nomenclature in the first article of this series.

Drug repurposing in pharmaceutical industry and its impact on market access: market access implications.

Background: Drug repurposing is a group of development strategies employed in order to overcome some of the hurdles innate to drug research and development. Drug repurposing includes drug repositioning, reformulation and combination.

Objective: This study aimed to identify the determinants of successful market access outcome for drug repurposing in the United States of America (USA) and in Europe.

Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: reassessment of nomenclature.

Background: Medicinal products that have been developed and approved for one disease may be the object of additional clinical development in other disease areas or of additional pharmaceutical development for new and different formulations. The newly developed products can be named as repositioned or reformulated products, respectively. Market access of repositioned or reformulated products in Europe and the United States is an interesting object of study as it may provide clarity about which parameters are assessed and considered to bring added value, other than the molecule itself.

Cost effectiveness of rasagiline and pramipexole as treatment strategies in early Parkinson's disease in the UK setting: an economic Markov model evaluation.

Background: Levodopa is the most effective treatment for the symptoms of Parkinson's disease (PD). However, after an initial period of benefit, several limitations become apparent, including motor complications such as dyskinesia. Dyskinesia can severely affect patients' quality of life and increases healthcare resource use.

Evaluation of patients on sertindole treatment after failure of other antipsychotics: a retrospective analysis.

Background: Use of the atypical antipsychotic sertindole was suspended for four years due to safety concerns. During the suspension, the regulatory authorities required further studies, including this one, to be conducted. The purpose of this study was to determine if a subset of patients with psychotic illness exists which particularly benefits from sertindole treatment after failure of other antipsychotic drugs, including atypical antipsychotics.