By: Janet Woodcock, M.D.
FDA’s approval today of the extended-release opioid pain medicine Hysingla ER (hydrocodone bitartrate) marks additional progress in the fight against the ongoing misuse and abuse of prescription opioids. Hysingla ER’s approval provides prescribers with another option for managing pain severe enough to require daily, around-the-clock, long term opioid treatment in patients for whom alternative treatment options are inadequate, while potentially reducing hydrocodone abuse.
In pre-approval testing, Hysingla ER exhibited properties that we expect will reduce the likelihood users could abuse the drug by chewing the tablet and ingesting it orally, or crushing it into powder for snorting or injecting. This is important because immediate-release combination products containing hydrocodone are among the most frequently abused opioid products. Hysingla ER is the fourth prescription opioid approved with product labeling that is consistent with the FDA’s 2013 guidance on abuse-deterrent opioids. The drug’s abuse-deterrent properties are expected to reduce – but not totally prevent – abuse by these routes.
While Hysingla ER has the same active ingredient (hydrocodone) as Zohydro ER, the only other approved extended-release hydrocodone product, there are important differences between the two. Hysingla ER has approved abuse-deterrent labeling, while Zohydro ER does not. Also, Zohydro ER is taken every 12 hours, and so comes in lower dosage strengths than Hysingla ER, which is taken every 24 hours. FDA has not yet determined whether Hysingla ER will prove to be safer than Zohydro ER.
It’s important to address some potential misperceptions about these extended-release hydrocodone products.
First, it would be misleading to suggest these products are stronger than other opioids on the market. Both Zohydro ER and Hysingla ER contain larger amounts of hydrocodone compared to immediate-release hydrocodone combination products because they need to be taken much less frequently. The range of tablet strengths for Hysingla ER is comparable to the strengths of existing approved extended-release opioids. The highest tablet strength of Hysingla ER, 120 mg, is comparable in potency to the currently marketed highest tablet and capsule strengths of extended-release morphine and hydromorphone products which, like Hysingla ER, are taken once daily.
Second, we do not expect these drugs to increase the number of patients treated with opioids. FDA is monitoring the use of all opioid products carefully and has been monitoring Zohydro ER prescribing since it was approved. In July 2014, Zohydro ER’s sixth month of marketing, there were 3,588 outpatient retail prescriptions dispensed. This represents 0.23% of the 1.6 million extended release, long acting (ER/LA) opioid analgesic prescriptions and only 0.02% of the nearly 18 million prescriptions dispensed for all opioid analgesics during the same month.
As with all extended release opioid medicines, FDA will carefully monitor and assess the use of Hysingla ER over time, and we are requiring the manufacturer to conduct studies to measure the effects of the abuse-deterrent features on abuse in the community.
Third, FDA has heard concerns about whether there is a need for additional prescription opioids. Given what we know about the needs of doctors and patients for additional choices of medicines, we believe having an additional choice of pain medicine like Hysingla ER, the first once daily hydrocodone product, is beneficial overall when treating patients in pain.
This latest approval also marks an important reminder of the limitations of today’s abuse-deterrent formulations. The reality is that opioids with abuse-deterrent properties can still be abused. Currently available abuse-deterrent technologies are important and offer a step in the right direction, but the science in this area is still evolving.
Prescription opioids with abuse-deterrent properties will not completely fix the prescription opioid abuse problem, but they can be part of a comprehensive approach to combat the epidemic. And the development of abuse-deterrent opioids is only one of many elements of FDA’s overall approach, which includes provider and patient education, close monitoring of approved opioids, and review and approval of drugs to treat addiction and prevent overdose. We will continue to work hard to address the serious problem of opioid abuse while providing needed pain medicines for patients.
Janet Woodcock, M.D., is Director of FDA’s Center for Drug Evaluation and Research