FDA fights opioid abuse with industry guidance

Development of drugs that cannot be snorted or injected may cut levels of misuse, watchdog advises.

The US Food and Drug Administration (FDA) has approved brexpiprazole (Otsuka Pharmaceutical’s Rexulti) for the treatment of adults with schizophrenia. In the image, Building 66 of the FDA

Measures to limit the abuse of, or risk of overdose from, opioid drugs have been issued by the US Food and Drug Administration (FDA) in guidance for the pharmaceutical industry.

While opioid drugs are an important tool in treating chronic pain, levels of opioid abuse in the United States have risen in line with a three-fold increase in their prescription over the past 20 years. The 2013 National Survey on Drug Use and Health estimated that almost one in 10, or 24.6 million, Americans aged 12 years or older were illicit drug users, with 4.5 million (1.7%) using prescription pain relievers. Opioid analgesics have been linked with more deaths than cocaine and heroin put together.

The FDA advice, ‘Guidance for industry: abuse-deterrent opioids — evaluation and labelling’, encourages companies to develop drugs with inbuilt abuse deterrents. This approach will allow the drugs to be used as prescribed, but make them harder to abuse, for example formulations that cannot be injected or snorted. The guidance includes recommendations on which studies to carry out to demonstrate abuse-deterrent properties, and how they should be performed and evaluated. It also includes advice on which labelling claims may be approved.

“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” says FDA commissioner Margaret Hamburg. “We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”

The challenge is to create a balance between the importance of pain relief and reductions in opioid misuse and abuse. Opioid medications must remain easy to use for carers or patients who are often elderly, disabled by chronic pain conditions or who have life-limiting conditions such as cancer.

It is also important that chronic pain remains an attractive and cost-effective therapeutic area for drug developers. One industry representative, who preferred not to be named, says he is concerned that focusing on prevention of abuse will make it more difficult for companies to get beneficial products to the market.

“There is a move already to reduce narcotic usage for pain,” he says. “I would rather see more education for both patients and physicians, and better protocols for dispensing and distribution.”

The American Pharmacists Association (APhA) had also expressed concerns about the potential for a reduction in access to opioid analgesics. In its response to a consultation on the FDA’s draft guidance, it urged the FDA to retain opioid analgesics in current formulations and argued that these still have a place in settings where abuse and diversion is less likely, such as hospitals, palliative care facilities and long-term care facilities. The APhA also wants the FDA to work with state boards of medicine and pharmacy to help them develop guidance for practitioners on when it is appropriate to prescribe and dispense formulations which have the potential to be abused and when new formulations are required.

Last updated
The Pharmaceutical Journal, PJ, 18 April 2015, Vol 294, No 7858;294(7858):DOI:10.1211/PJ.2015.20068298

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