FDA Approves New Extended-Release, Abuse-Resistant Hydrocodone Product

The US Food and Drug Administration (FDA) today 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.

Manufactured by Purdue Pharma LP using the Resistec proprietary extended-release solid oral platform, Hysingla is the first and only hydrocodone product to be recognized by the FDA as having abuse-deterrent properties that are expected to deter misuse and abuse via chewing, snorting and injection. However, according to Purdue, abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible.

The announcement from Purdue notes that “Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, Hysingla ER should be reserved for use in patients for whom alternative treatment options (eg, non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Hysingla ER is not indicated as an as-needed analgesic. Hysingla ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, known or suspected paralytic ileus and gastrointestinal obstruction, and hypersensitivity to any component of Hysingla ER or the active ingredient, hydrocodone bitartrate.”

Hysingla will be available in dosage strengths of 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg.

Charles E. Argoff, MD, Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Center at Albany Medical Center in New York, said, “The burden of chronic pain and the abuse of prescription medications are both pressing societal problems… Opioids are an essential tool in our arsenal of medical treatments options, so greater availability and use of opioid analgesics with abuse-deterrent properties has the potential to help alleviate suffering among people with chronic pain while reducing the abuse of these medications. Furthermore, this product gives treatment providers the option to use hydrocodone without acetaminophen if they are concerned that their patients may be taking too much acetaminophen on a daily basis.”

According to the FDA, 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. The tablet is difficult to crush, break or dissolve. It also forms a viscous hydrogel (thick gel) and cannot be easily prepared for injection.” Although the FDA has determined that the physical and chemical properties of Hysingla ER “are expected to make abuse by these routes difficult,” the agency has cautioned that abuse of Hysingla ER by these routes is still possible.

Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said “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 US… 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.”

The FDA approved Hysingla ER based on safety and efficacy data from a clinical trial of 905 people with chronic low back pain; data from studies conducted in laboratories and in people demonstrated the abuse-deterrent features of Hysingla ER for certain types of abuse.

The most common side effects associated with treatment Hysingla ER are constipation, nausea, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence.

As a condition of approval, 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. Hysingla ER is also part of the ER/LA Opioid Analgesics REMS program.