Long-term efficacy, safety and tolerability of Remoxy for the management of chronic pain

Abstract

Historically, chronic pain generally went under-treated for a variety of objective and subjective reasons, including difficulty to objectively diagnose and manage over a long period of time, potential serious adverse effects of commonly available medications, and patient, healthcare and societal concerns over opioid medications. More recently, in an effort to redress the under-treatment of pain, the number of prescriptions of opioid analgesics has risen dramatically. However, paralleling the increased legitimate use has been a concomitant increase in opioid abuse, misuse and diversion. Pharmaceutical companies have responded by developing a variety of opioid formulations designed to deter abuse by making the products more difficult to tamper with. One such product is Remoxy^®, an extended-release formulation of the strong opioid oxycodone. We review the efficacy, safety and tolerability of this formulation based on the available published literature.

Keywords:

• abuse
• abuse-deterrent
• chronic pain
• opioid
• oxycodone
• Remoxy

Financial & competing interests disclosure

J Pergolizzi is a senior partner in NEMA Research Inc., and has served as a consultant for Johnson & Johnson, Purdue Pharma LP, Baxter International Inc., Endo Pharmaceuticals Inc., Collegium Pharmaceutical, and Iroko. R Taylor Jr is an employee of NEMA Research. G Zampogna is a medical fellow at NEMA Research. RB Raffa is a speaker, consultant, and/or basic science investigator for several pharmaceutical companies involved in analgesics research but receives no royalty (cash or otherwise) from the sale of any product. The authors have 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.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Opioids are generally the go-to analgesic for moderate-to-severe pain; however, there are patient, healthcare and societal concerns over opioid use.

• Increase in opioid abuse, misuse and diversion has paralleled the increase in opioid prescriptions in the USA.

• Pharmaceutical companies have responded to the increase in opioid abuse, misuse and diversion by developing opioid formulations that have an increased resistance to tampering.

• A novel tamper-resistant extended-release oxycodone, branded as Remoxy^®, is currently in clinical development.

• Two Phase III trials have demonstrated Remoxy’s effectiveness in reducing pain intensity and improving quality of life when compared with placebo.

• Long-term safety (12 months) has been demonstrated for Remoxy in a Phase III study; adverse events were typical of those of other opioids.

• Abuse potential for Remoxy was significantly different when compared with currently available oxycodone products in small clinical studies, a reduction in drug liking as well as drug high and good effects.

• Larger, real-life epidemiological and clinical studies may be needed to compare abuse and misuse to other opioids in the same class.