The Food and Drug Administration is set to consider painkillers that can’t be easily abused, but the growing technology likely won’t be a catchall to end the opioid epidemic.
A panel of experts on Thursday is set to debate whether to recommend approval of two new drugs: an extended-release oxycodone painkiller from Collegium Pharmaceuticals and an immediate-release oxycodone drug from Purdue Pharmaceuticals.
Both have abuse-deterrent features that ensure the painkiller cannot be crushed and snorted or administered intravenously, which are methods that give addicts a quicker high. However, the drug can still be abused orally.
Health officials believe abuse-deterrent painkillers can help stem the tide of opioid abuse, which has soared in the U.S.
For the past 15 years, the number of prescription painkillers prescribed and sold in the U.S. has quadrupled, but there hasn’t been a change in the amount of pain that Americans report, according to the Centers for Disease Control and Prevention.
The FDA advisers will look at both drugs’ safety and effectiveness data and make a recommendation on whether the FDA should approve them. The agency does not have to follow the recommendation, but it usually does. A decision on the two drugs is expected by the end of the year.
If the drugs get approved, they would bring the number of abuse-deterrent painkillers on the market to six.
Currently four opioid painkillers with abuse-deterrent features are on the market. All of them are extended-release and have been approved in the past few years.
The agency has made a concerted effort recently to spur the development of such painkillers. Earlier this year the FDA released a final regulatory guidance on how to prove to the agency that a drug’s abuse-deterrent formulation works.
The moves come amid pressure from lawmakers over the agency’s handling of prescription painkillers, a growing public health issue. In 2013, the FDA approved the painkiller Zohydro without abuse-deterrent features. The decision sparked a massive outcry from Congress as lawmakers were concerned the agency would be adding to the opioid epidemic.
The House 2016 spending bill for the agency withheld $20 million in funding unless the FDA finalized the regulatory guidance by June.
But even if more abuse-deterrent drugs hit the market, patients may have trouble affording them.
A big problem is that the drugs are more expensive than low-cost generics that don’t contain abuse-deterrent features.
A June study from Avalere Health found that Medicare coverage tends to favor low-cost generic opioids rather than pricier brand-name abuse-deterrent painkillers.
For instance, in 2013 popular painkiller Oxycontin became abuse-deterrent. The drug’s coverage rate in Medicare Part D, the program’s prescription drug plan, dropped from 61 percent in 2012 to 33 percent this year, Avalere said.
A two-month supply of Oxycontin 20 mg is estimated to cost $316, according to the website Healthcare Bluebook, which offers an average fair price of drug prices. A generic version is about $100 cheaper.
Several states are trying to make sure that insurers and health plans adopt the drugs.
The Illinois Senate introduced legislation to require public health plans and insurers to cover abuse-deterrent opioids. It also prohibits an insurer from requiring a patient to first use an opioid without abuse-deterrent protections before switching to one with such protections.
Several other states, such as Connecticut, are considering similar laws.
Another issue is whether the drugs are prescribed appropriately.
For patients with non-cancer pain, “opioids are more likely to harm than help,” said Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing.
He noted that a broad indication for the drugs could be a problem, as extended-release opioids shouldn’t be used for chronic non-cancer pain.
If doctors continue to inappropriately prescribe long-acting opioids for issues such as lower back pain, “then the opioid crisis will not get any better,” he said.
