New Data Revealed from a Sponsor Collaboration Focused on Safety of Long-Acting Opiates


Applied Clinical Trials

Forging new partnerships focused on the safety of long-acting opiates is important, as public health questions surrounding drug abuse and addiction have increased, along with regulations governing these products once they reach the market.

Forging new partnerships focused on the safety of long-acting opiates is important, as public health questions surrounding drug abuse and addiction have increased, along with regulations governing these products once they reach the market.

James Young, VP of Global Product Development at Mallinckrodt Pharmaceuticals, believes that extended-release (ER) or long-acting (LA) opioid therapy plays a vital role in medicine, offering a management mechanism for those patients with severe chronic intractable pain who have not gotten relief from other means of treatment. The Institute of Medicine reports that more than 100 million Americans are affected by chronic pain, with some $600 billion spent annually in medical costs and lost productivity. Young noted, while presenting at a Partnerships in Clinical Trials session, that these drugs, however, come with significant baggage-mainly in the potential for abuse. Young explains that the makers of opioid therapy are diligent in their efforts to prevent the misuse of their drugs, but are continually challenged by a faction of consumers that are adept, persistent, and creative in finding ways to abuse treatment. 



Amid concerns over rising abuse levels of ER/LA opiates, the FDA has increasingly engaged with biopharma companies on ways to combat the tide-and further assess the serious risks of misuse, abuse, addiction, overdose, and death associated with their long-term use. Initiatives have included mandating risk evaluation and mitigation strategies (REMS) for recently approved narcotics, as well as heightened post-marketing requirements (PMRs). REMS programs in the context of opiate products can involve sponsor training of physicians on the appropriate use of their drugs; publishing information about the opiate and any safety issues to raise awareness among healthcare providers; and special labeling, with prescribing language that details the misuse and abuse of these drugs.   

Young pointed out that the FDA has recently issued a series of PMRs to new drug application holders for ER/LA opioid analgesic products. This has resulted, he said, in increasing partnership activity between drug sponsors to investigate public health questions related to opiate abuse and the effects of these drugs on society. Young and Mitchell Katz, Head of Medical Research and Drug Safety Operations at Purdue Pharma, shared some of the initial learnings from a nine-company industry collaboration focused on the new PMRs for opiate therapy. Among the key findings Katz outlined was the importance of a centralized, unbiased, and independent facilitator to help mange observational trials across all countries; routine and ongoing collaboration and communication with FDA; and the need for more active and open discussion with all the sponsor groups involved. To those ends, the establishment of a post-marketing committee to work closely with FDA, commissioning CROs and vendors for project management and other functions, and forming a steering committee are critical steps to structuring the partnership. They should all include interdisciplinary experts spanning regulatory affairs, clinical, legal, operations, and medical functions, Katz said.  He noted that when conducting observational studies of ER/LA opiates, the collaboration should also leverage sponsor internal risk management groups, which routinely examine aspects such as prescribing habits and other contributors to potential abuse.

A key to the collaboration’s success will be the ability to manage the complexity of the partnership, which involves 10 observational trials, one clinical trial, and various products, study populations, and schedules. The partners have been laying the foundation for the program for more than 18 months and it is now in the protocol finalization stage. As the project transitions to the execution phase, Young and Katz acknowledge that most of the challenges are likely still to come. Nevertheless, they do believe the partnership-with its overriding goal of advancing public health-is breaking new ground. Just how much will likely come down to, first, answering critical fundamental operational questions: which member holds the investigational new drug application; who provides the regulatory oversight; how will the safety reporting be managed; whose SOPs will be used; and what is the optimal database structure. From there, the implementation and data generation will dictate the collaboration’s ultimate impact in improving the long-term safety of ER/LA opiates for those patients that need them.


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