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FDA releases guidance on how to prevent abuse of opioid painkillers

Explains to companies best ways to make tamper-resistant drugs

FDA headquarters White Oak

The US Food and Drug Administration has taken a step forward in tackling abuse of opioid-based painkillers by producing industry guidance on how to produce drugs that are resistant to misuse.

The draft guidance is designed to support pharma companies planning to launch new formulations of opioid products, and contains information about the type of studies necessary to demonstrate a drug has abuse-deterrent properties.

Details on how these studies will be evaluated by the FDA and potential labelling claims are also included in its Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling.

FDA commissioner Dr Maragaret Hamburg said abuse of prescription opioids – which are used in the treatment of acute and chronic pain – is a “major public health challenge” for the US and more action needs to be done to address it.

Such abuse, which includes crushing drugs to be snorted through the noise or dissolving the opioid so it can be injected, can lead to injuries and deaths, said the FDA, and the creation of guidelines for their manufacture will help cut down this misuse.

“Our nation is in the midst of a prescription drug abuse epidemic,” said Gil Kerlikowske, director of the US' National Drug Control Policy.

“While there are no silver bullet solutions to this public health and safety challenge, abuse-deterrent formulations of powerful prescription opioids can make a difference in addressing this epidemic.”

The guidance comes one month after an FDA advisory committee voted against the approval of opioid-containing Zohydro from Zogenix due in part to its potential for abuse.

At the time, the panel said that any decision about the drug's final approval should wait until the FDA adds a requirement for tamper-resistant formulations in painkillers. Zogenix is currently working on an abuse-deterrent formulation of its drug.

Other companies making efforts in the production of abuse-resistant opioids include Endo, which has already released an extended release version of the oxymorphone Opana that is designed to protect against being tampered with.

The FDA is now seeking public comment on its draft guidance and is also encouraging “additional scientific and clinical research that will advance the development and assessment of abuse-deterrent technologies”.

A finalised document is then planned following a public meeting to discuss any comments raised during the 60-day consultation period.

10th January 2013

From: Regulatory

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