内容紹介
Outcomes of an Independent Clinical Study to Compare Branded and Generic Formulations of Sustained-Release Oxycodone
Summary
To evaluate the potential for the adoption of a generic formulation of sustained-release oxycodone(Oxycodone SR Capsules), an independent clinical study was planned to accurately evaluate the efficacy and safety during a 9-day period. After a 3-day pretreatment period, the generic formulation was administered to patients with progressive cancer, who had been treated with a branded formulation(OxyContin® Tablets)of the drug for 5 days at the same dose. This was followed by a 1-day observation period. Drug administration to 3 patients with pulmonary cancer achieved the primary(dose, pain level, and adverse drug reactions)and secondary(rescue dose frequency and quality of life)endpoints, as well as safety goals. The merits of adopting a different dosage form were also noted. Independent data collection using an appropriate evaluation method consequently promoted the understanding of generic opioids in the clinical setting.
要旨
オキシコドン徐放剤の後発品(オキシコドン徐放カプセル)採用審議に当たり,有効性と安全性を正確に評価するため自主臨床試験を計画した。同剤の先発品(オキシコンチン®錠)を使用している進行癌患者を対象に,前治療期3日間を経て同一用量の後発品を5日間投与,後観察期1日の計9日間で有効性と安全性を評価した。入院中の肺癌患者3例に対して同剤を投与した結果,主要評価項目(投与量・疼痛の強度・有害事象)および副次的評価項目(レスキュー使用回数・生活の質),安全性いずれも同等であること,剤型の違いによるメリットもあることが判明した。適切な評価方法を定めて自院のデータを得たことにより,オピオイドの後発品に対する現場の理解が深まったと考えられる。
目次
Summary
To evaluate the potential for the adoption of a generic formulation of sustained-release oxycodone(Oxycodone SR Capsules), an independent clinical study was planned to accurately evaluate the efficacy and safety during a 9-day period. After a 3-day pretreatment period, the generic formulation was administered to patients with progressive cancer, who had been treated with a branded formulation(OxyContin® Tablets)of the drug for 5 days at the same dose. This was followed by a 1-day observation period. Drug administration to 3 patients with pulmonary cancer achieved the primary(dose, pain level, and adverse drug reactions)and secondary(rescue dose frequency and quality of life)endpoints, as well as safety goals. The merits of adopting a different dosage form were also noted. Independent data collection using an appropriate evaluation method consequently promoted the understanding of generic opioids in the clinical setting.
要旨
オキシコドン徐放剤の後発品(オキシコドン徐放カプセル)採用審議に当たり,有効性と安全性を正確に評価するため自主臨床試験を計画した。同剤の先発品(オキシコンチン®錠)を使用している進行癌患者を対象に,前治療期3日間を経て同一用量の後発品を5日間投与,後観察期1日の計9日間で有効性と安全性を評価した。入院中の肺癌患者3例に対して同剤を投与した結果,主要評価項目(投与量・疼痛の強度・有害事象)および副次的評価項目(レスキュー使用回数・生活の質),安全性いずれも同等であること,剤型の違いによるメリットもあることが判明した。適切な評価方法を定めて自院のデータを得たことにより,オピオイドの後発品に対する現場の理解が深まったと考えられる。