Earlier this year, the Food & Drug Administration (FDA) announced an opioid task force that would rework the agency’s approach to the medications. It’s noteworthy because FDA has been under fire for its recent history of approving new, stronger opioids too easily.
Robert Califf, MD, now the agency’s commissioner, spoke at the National Rx Drug Abuse & Heroin Summit in Atlanta and offered Behavioral Healthcare an exclusive update on progress on each of the items in the original plan.
Here is what the FDA has done and is doing through the task force.
1. Abuse deterrent formulations
Abuse deterrence can include adding naloxone to the product so that the effect of the opioids would be nonexistent if the drug was manipulated and injected. For example, OxyContin, which is an extended-release opioid for pain when taken orally, but has been crushed, chewed or snorted by users who wanted to get high. Manufacturer Purdue in 2010 reformulated it, and OxyContin abuse has gone down as a result.
There are concerns, however, that other pharmaceutical companies will not use abuse deterrent best practices and that the FDA won’t require them to. However, abuse deterrent formulations will be on the table in three upcoming new drug application discussions.
On May 5, FDA committees will discuss benzhydrocodone, a prodrug of hydrocodone and acetaminophen, submitted by KemPharm. The proposed indication is for the short-term (up to 14 days) management of acute pain. Then on June 7, the committees will discuss hydrodocone bitartrate extended-release tablets submitted by Teva, with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. On June 8, the committee will discuss oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules, submitted by Pfizer, with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committee will look at claims for abuse deterrence in these products.
2. Pediatric opioids
There are also concerns about pediatric opioids, and the FDA plans to hold a meeting April 12 to provide information on appropriate pediatric development plans for prescription opioid drugs and to discuss the proposed framework for a two-day joint meeting starting September 15. Following the FDA’s presentation, there will be a hearing to provide an opportunity for the public to provide input, including the use of opioids for control of debilitating pain in the pediatric population.
3. Risk assessment
In other moves, the FDA signed a contract last week with the National Academy of Medicine to examine the risk-benefit paradigm for opioids and announced changes to add black box warnings on immediate-release opioid labeling. It also recently issued draft guidance for generic versions of abuse deterrent opioids. There is also a new process to work with the industry to develop over-the-counter versions of naloxone as well as ongoing work to support non-opioid pain management options.