Purdue's Hysingla (single-entity hydrocodone) Receives FDA Approval
The U.S. Food and Drug Administration has approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to "treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate."
This is the second extended-release hydrocodone product approved by the FDA. The first, Zohydro, was approved October 13, 2013, but did not contain abuse-deterrant properties. Hysingla was designed to be abuse-deterrant by making the tablet difficult to crush, break or dissolve, noted the agency in a press release announcing the drug's approval.1
"Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected," wrote the agency. As noted, the tablet is difficult to crush, break or dissolve forming a viscous hydrogel (thick gel) that cannot be easily prepared for injection. The FDA has determined that these properties of Hysingla ER "make abuse by these routes difficult." However, abuse of Hysingla ER by these routes is still possible.
“While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the U.S.,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “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.”
Like most extended release opioids, Hysingla ER is not approved for, and should not be used for, as-needed pain relief. Given Hysingla ER’s risks for abuse, misuse and addiction, it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management, noted the agency
As a single-entity opioid, Hysingla ER does not carry the serious liver toxicity risks associated with hydrocodone combination products containing acetaminophen. The FDA encourages health care professionals to review and consider all available information as part of their decision-making when prescribing opioid analgesics.
According to the FDA, Hysingla ER will be available in 20, 30, 40, 60, 80, 100 and 120 milligrams (mg) of hydrocodone to be taken every 24 hours. While Hysingla ER contains larger amounts of hydrocodone compared to immediate-release hydrocodone combination products, the range of tablet strengths of Hysingla ER is comparable to existing approved ER opioids, said the agency.
The safety and effectiveness of Hysingla ER were evaluated in a clinical trial of 905 people with chronic low back pain. Additional data from studies conducted in laboratories and in people demonstrated the abuse-deterrent features of Hysingla ER for certain types of abuse (oral, snorting and injection). The most common side effects of Hysingla ER are constipation, nausea, fatigue, upper respiratory tract infection, dizziness, headache and drowsiness (somnolence).
The FDA is requiring postmarketing studies of Hysingla ER to assess the effects of the abuse-deterrent features on the risk for abuse of Hysingla ER and the consequences of that abuse in the community. In addition, Hysingla ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/LA opioids.
Hysingla ER is manufactured by Stamford-based Purdue Pharma L.P.