The FDA commissioner, Dr. Scott Gottlieb, has made the opioid crisis a priority in his time at the agency. Yesterday, the regulatory body issued guidance to help promote the development of generic opioids designed to prevent abuse.
To date, the FDA has approved 10 of these products, called abuse-deterrent opioids. But, as Gottlieb noted in a statement, uptake by physicians has been slow.
“The reason for their more limited use is likely multifold. We know there can be a learning curve that comes with new technologies. Some prescribers may not be aware of the existence of these drugs, or may be uncertain of when to prescribe the abuse-deterrent versions,” he said.
“But we also know a significant barrier to use can be price. Because these new formulations are currently only available as brand-name products, they’re inherently more expensive than the numerous non-abuse deterrent formulations that are also available in generic formulations.”
The FDA commissioner said he believes that promoting the development of opioids that are harder to manipulate and abuse will have meaningful benefits for the public, especially for people suffering from chronic pain.
“But to transition this market more quickly to the ADFs, and consider permanently withdrawing the older formulations that lack abuse-deterrent features in the event these products were judged to be less safe ‒ there are a number of factors we must consider. One of the factors that the FDA would consider relates to generic access. We must have the potential to improve access to the newer formulations, for appropriately selected and monitored patients, through the introduction of generic competitors,” he explained.
In the FDA’s guidance, the agency recommended that companies conduct studies showing that a generic drug is no less abuse-deterrent than its brand-name counterpart.
“We’re also taking additional steps beyond the new guidance to help developers of generic ADFs navigate the regulatory path to market as quickly as possible and make the review process more efficient and predictable,” he added. “In addition, we’re also taking a flexible, adaptive approach to the evaluation and labeling of ADF opioids.”
The commissioner encouraged generic drug developers to meet with the FDA before submitting their applications to talk through scientific and regulatory issues.
Gottlieb cautioned that the science behind abuse deterrence is still new and that prescribers need to understand that these drugs do not prevent addiction. The FDA is conducting a study, he said, to evaluate if labeling the drugs as “abuse-deterrent” is an accurate way to communicate their benefits.
In July, Endo Pharmaceuticals (NSDQ:ENDP) voluntarily pulled its Opana ER painkiller from the market after the FDA asked the company to pull the plug on the opioid, arguing that the benefits of the abuse-deterrent drug no longer outweigh the risks.
The request from the FDA marked the first time the federal regulatory watchdog urged a company to remove an opioid due to concerns of abuse.
Endo’s Opana ER won FDA approval in 2006 for the management of moderate-to-severe pain. Six years later, the company reformulated Opana ER with the intent to make it harder for people to snort or inject it.
But a review of postmarketing data showed that the reformulation may have encouraged users to shift from snorting Opana to injecting the painkiller by mixing it with large volumes of solvent.
The painkiller was even linked to a 2015 HIV outbreak in Indiana after people addicted to opioids shared needles while injecting Opana.
“This final guidance is one piece of the FDA’s ongoing work aimed at finding solutions to combat the opioid crisis. This effort must include treatments for those who are already addicted,” Gottlieb said. “That’s why we are also focusing new efforts on the development and promotion of medication-assisted treatments for addiction. As we balance the need to effectively treat pain with the public health emergency related to opioid addiction, we must find creative ways to prevent new cases of abuse and addiction.”
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