Oxycodone Extended-Release Using Gel-Cap Technology to Resist Alteration and Abuse for the Treatment of Moderate-To-Severe Pain

Abstract

SUMMARY Abuse of commercial oxycodone extended-release is common, fueling motivation by drug developers to investigate new formulations intended to resist alteration and abuse without compromising effective around-the-clock analgesia. An oral formulation of oxycodone extended-release that uses gel-cap technology as a tamper-resistant barrier is currently in development. Gel-cap oxycodone extended-release met the primary end point of significantly improved mean pain intensity scores compared with placebo in a Phase III, placebo-controlled trial. In studies of abuse liability, preliminary results indicate the formulation could be less attractive to would-be abusers. Unanswered questions include whether less real-world abuse and increased safety would follow product launch and how this and other formulations aimed at reducing abuse potential might affect adherent patients.

Financial & competing interests disclosure

LR Webster has served as a consultant and on the advisory boards for AlphaBioCom, American Board of Pain Medicine, AstraZeneca, Boston Scientific, Cephalon Inc., Covidien Mallinckrodt, Janssen Pharmaceutical KK, Nevro Corporation, Pharmacofore Inc. and Theravance. She has received research grants from Adolor Corp., Alkermes Inc., Allergan Inc., Astellas, AstraZeneca, Bayer Healthcare, BioDelivery Systems International, Boston Scientific, Cephalon, Collegium Pharmaceuticals, Covidien, Eisai, Elan Pharmaceuticals, Gilead Sciences, GlaxoSmithKline, King Pharmaceuticals, Meagan Medical, Medtronic, Nektar Therapeutics, NeurogesX Inc, Shionogi USA Inc., St. Renatus, SuCampo Pharma Americas USA, TEVA Pharmaceuticals (Sub-I), Theravance Inc., Vertex and Xanodyne Pharmaceuticals. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

B Dove, of Lifetree Clinical Research in Salt Lake City, UT, USA, provided medical writing and editorial assistance for this article.

Notes

Data taken from [2,3].

Additional information

Funding

LR Webster has served as a consultant and on the advisory boards for AlphaBioCom, American Board of Pain Medicine, AstraZeneca, Boston Scientific, Cephalon Inc., Covidien Mallinckrodt, Janssen Pharmaceutical KK, Nevro Corporation, Pharmacofore Inc. and Theravance. She has received research grants from Adolor Corp., Alkermes Inc., Allergan Inc., Astellas, AstraZeneca, Bayer Healthcare, BioDelivery Systems International, Boston Scientific, Cephalon, Collegium Pharmaceuticals, Covidien, Eisai, Elan Pharmaceuticals, Gilead Sciences, GlaxoSmithKline, King Pharmaceuticals, Meagan Medical, Medtronic, Nektar Therapeutics, NeurogesX Inc, Shionogi USA Inc., St. Renatus, SuCampo Pharma Americas USA, TEVA Pharmaceuticals (Sub-I), Theravance Inc., Vertex and Xanodyne Pharmaceuticals. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. B Dove, of Lifetree Clinical Research in Salt Lake City, UT, USA, provided medical writing and editorial assistance for this article.