Opioid Drug Abuse Will be Tackled through New Delivery Methods and Post-Marketing Studies

Monday 18 February 2013, Amsterdam

The opioid pain management market will continue to evolve over the coming years with new products and post-marketing studies that aim to reduce the risk of abuse, states a new report by healthcare experts.

The new report explores the future of abuse-resistant formulations, which have become a vital feature in today’s healthcare environment, due to the fact that patients experiencing moderate or severe pain are treated almost exclusively with opioid analgesics.

We note that in the US, Germany, the UK, France, Italy, Spain, and Japan, 352 opioid-based products are currently approved to treat a range of painful conditions, based upon 16 different opioid compounds.

However, while both the Food and Drug Administration (FDA) and European Medicines Agency (EMA) set strict regulatory requirements for marketed opioid analgesics, physician associations have also become more vocal about raising public awareness of opioid abuse. Physicians are forced to exercise a high degree of caution when prescribing opioid medications, and for this reason the prescription volume of opioids in the US may eventually reach a plateau.

In order to tackle this problem, many companies are working to develop abuse-resistant formulations of Extended-Release (ER) opioid analgesics. Embeda (morphine sulfate and naltrexone hydrochloride), launched in the US in 2009 as the first opioid product designed to be abuse-resistant, and a whole range of abuse-resistant reformulations of existing products have now hit the market.

Rigorous regulations are in place to control the opioid drug market, and, in the US, almost every marketing approval for an ER opioid launched recently has been accompanied by a Risk Evaluation and Mitigation Strategy (REMS), which demands that license holders provide physician training and raise patient awareness regarding the risks of opioid abuse. Many orally administered ER products also require post-marketing studies to examine the efficacy of abuse-resistant formulations.

For instance, post-marketing data for Embeda has so far has shown the drug has a safety profile comparable to the standard ER morphine formulation, and a possible degree of abuse resistance. Though it will take several years yet for a substantial amount of post-marketing data to be collected and analysed, Embeda’s initial reports are a positive beginning in the effort to curb opioid abuse.

Orally administered ER opioids remain the dominant product formulation at present, but transdermal patch products may represent a future market hit. Although their current high pricing and analgesic effects are a deterrent for some physicians, their ease of application, long-lasting analgesic effects, and inherent protection against abuse may yet see the alternate administration method take over the pain relief market in the coming year