ER opioid analgesic with abuse-deterrent properties approved by FDA

November 21, 2014

An extended-release (ER) opioid analgesic, hydrocodone bitartrate (Hysingla ER, Purdue Pharma) has been approved by FDA for the management of pain severe enough to require daily, 24-hour, long-term opioid treatment. Alternative treatment options must also have been found to be inadequate.

An extended-release (ER) opioid analgesic, hydrocodone bitartrate (Hysingla ER, Purdue Pharma) has been approved by FDA for the management of pain severe enough to require daily, 24-hour, long-term opioid treatment. Alternative treatment options must also have been found to be inadequate.

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This opioid medication is not approved for as-needed pain relief. Individuals for whom alternative treatment options are not effective or tolerated, or would be inadequate to provide a sufficient level of pain management are the only ones to whom hydrocodone bitartrate ER should be prescribed because of the risks for abuse, misuse, and addiction.

The approved labeling describes this opioid’s abuse-deterrent properties, which meet the 2013 draft guidance for industry by FDA, Abuse-Deterrent Opioids – Evaluation and Labeling. FDA has recognized hydrocodone bitartrate ER as the first and only hydrocodone product that has these properties to help deter misuse and abuse of the drug by chewing, snorting, or injecting it.

Properties of the drug that are expected to reduce such abuse include it being difficult to crush, break, or dissolve the tablet. Injection is specifically less easy to do with the drug because it forms a viscous hydrogel, or thick gel, making it difficult to prepare for this route. Nevertheless, even these forms of abuse are not totally preventable. It also is cautioned that abuse of hydrocodone bitartrate ER is still possible via intravenous, intranasal, and oral routes.

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“While the science of abuse deterrence is still evolving,” explained Janet Woodcock, MD, the director of FDA’s Center for Drug Evaluation and Research, “the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the US.”

A clinical trial including 905 persons with chronic low back pain was undertaken to evaluate the safety and effectiveness of hydrocodone bitartrate ER. Its abuse-deterrent features were shown in data gathered from studies conducted in laboratories and in individuals.

The manufacturer plans to launch hydrocodone bitartrate ER in the United States in early 2015. Dosage strengths will include 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, and 120 mg, with a dosage schedule of once every 24 hours.

Healthcare professionals prescribing opioid analgesics are encouraged by FDA to review and consider all available information in their decision-making process.

FDA has required the manufacturer to undertake postmarketing surveillance studies in order to determine the extent of the drug’s impact on reducing abuse and diversion in the community

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