|FDA CDER Director Janet Woodcock|
The FDA has faced a firestorm of criticism since approving Zogenix's ($ZGNX) superstrength painkiller Zohydro last year, drawing outcry from lawmakers and industry groups concerned with the drug's all-hydrocodone formula with no features to deter addicts from abusing it. Now the FDA has approved Hysingla, a painkiller Purdue Pharma hopes will poach Zohydro's market share and sidestep the furor that has engulfed that drug.
The agency based its approval on a clinical trial of 905 individuals with chronic low back pain and additional data from studies which demonstrated that Hysingla prevented abuse including oral, snorting and injection, the FDA said in a statement. Regulators are also calling for postmarketing studies to further investigate the drug's abuse-deterrent features in certain patient groups.
"We are proud to offer healthcare professionals and chronic pain patients another treatment option," Purdue Pharma CEO Mark Timney said in a statement. "Hysingla ER is the third product in our pain management portfolio to receive an FDA label describing its abuse-deterrent characteristics. These innovations are an important step forward in helping meet patients' needs while also working to deter misuse and abuse."
Like Zohydro, Hysingla contains an extended-release formula of hydrocodone designed for long-term use. But unlike its predecessor, Hysingla is taken every 24 hours rather than every 12 hours like Zohydro.
And while abuse of Hysingla is still possible, the agency is touting the drug's formula as a way to address prescription drug abuse in the U.S., Director of FDA's Center for Drug Evaluation and Research Janet Woodcock said in an FDA blog post. Hysingla and Zohydro contain larger amounts of hydrocodone than other products because they need to be taken less frequently, and the range of strengths for Hysingla is comparable to that of existing extended-release drugs.
Woodcock also noted in her blog post that the FDA does not expect drugs like Hysingla or Zohydro to increase the number of patients treated with opioids, and that the agency plans to monitor prescriptions closely. Zohydro chalked up 3,588 outpatient retail prescriptions dispensed in its first 6 months of marketing, representing only 0.02% of the nearly 18 million prescriptions dispensed for all opioid analgesics during the same month, Woodcock said.
"Preventing prescription opioid abuse is a top public health priority for the FDA, and encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain," she said in a statement.
|FDA Commissioner Margaret Hamburg|
As soon as the FDA approved Zohydro in October 2013, FDA Commissioner Margaret Hamburg came under attack by law enforcement, politicians and anti-addiction groups, some calling for her resignation. They said the approval was bad policy destined to lead to more prescription drug abuse and deadly overdoses. The governor of Massachusetts tried banning Zohydro there but was rebuffed by a federal judge who said the governor lacked that authority.
Meanwhile, Zogenix is responding to the public outcry with a new, modified version of Zohydro. In October, the company applied for FDA approval for a capsule formulation of the drug designed to make it difficult for addicts to abuse it by snorting or injecting it. Zogenix expects the FDA to decide on the new version of the drug in the first quarter of 2015. Pfizer ($PFE) and ($TEVA) are also developing painkillers that could provide some competition to Zogenix and Purdue Pharma's products.
- here's the FDA release
- read the FDA blog post
- here's Purdue Pharma's statement