Hysingla ER by Purdue Pharma LP
The FDA has approved Purdue Pharma LP’s Hysingla ER (hydrocodone bitartrate) extendedrelease tablets CII for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The approval carries 2 limitations: 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 extendedrelease opioid formulations, Hysingla ER should be reserved for patients in whom alternative treatment options are ineffective, not tolerated, or would otherwise be inadequate to provide sufficient pain management, and Hysingla ER is not indicated as an as-needed medication. Hysingla ER also carries a boxed warning (see Contraindications, Warnings and Precautions).1
The overuse of acetaminophen has been reported as a leading cause of acute liver failure in the United States. Because Hysingla ER does not contain acetaminophen, it does not carry the liver toxicity risks associated with other acetaminophen-containing hydrocodone products.2,3
Hysingla ER utilizes Purdue’s Resistec formulation, which uses polymers and processing to confer tablet hardness and causes the tablet to form a viscous hydrogel when dissolved. Although these properties are expected to make the abuse and misuse of Hysingla ER more difficult, its abuse may still be possible.2,3 The FDA is requiring postmarketing studies to evaluate the effects of these abuse-deterrent features on the risk for abuse of Hysingla ER and the consequences of that abuse in the community.3
Dosage and Administration
Opioid-naïve patients should begin treatment with 20 mg orally every 24 hours. Dose titration may occur every 3 to 5 days. Tablets must be swallowed whole, 1 at a time, and with enough water to ensure that the tablet is completely swallowed. Hysingla ER should not be discontinued abruptly in a physically dependent patient.1
Hysingla ER was evaluated in a randomized, double-blind, placebocontrolled, multi-center, 12-week trial of 905 people with chronic low back pain. The group using Hysingla ER was found to have greater pain relief than the placebo group, with a statistically significant difference in weekly average pain scores.1,3
Contraindications, Warnings, and Precautions
Hysingla ER carries the following boxed warning:
- Its use exposes patients to risks of addiction, abuse, and misuse, which can lead to overdose or death. Risk should be assessed prior to prescribing.
- Serious, life-threatening or fatal respiratory depression may occur. Patients should be monitored closely, especially following initiation of treatment or dose increases.
- Accidental ingestion may result in a fatal overdose, especially in children.
- Prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome.
- Initiation of CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose.
Hysingla ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, known or suspected paralytic ileus and gastrointestinal obstruction, or hypersensitivity to the active ingredient or any other component of Hysingla ER.
Hysingla ER is a Schedule II controlled substance with a high potential for abuse. Concomitant administration with central nervous system depressants may cause profound sedation, respiratory depression, and death. Elderly, cachectic, or debilitated patients and those with chronic pulmonary disease are at increased risk for life-threatening respiratory depression. Closely monitor patients with head injury or increased intracranial pressure. Avoid Hysingla ER in patients with impaired consciousness or coma susceptible to intracranial CO2 retention. Use cautiously in patients with difficulty swallowing. Hysingla ER may impair mental or physical abilities. QTc prolongation has been observed at daily doses of 160 mg.
Concomitant use with mixed agonists/ antagonists may precipitate withdrawal or decrease analgesic effect. Concurrent use of monoamine oxidase inhibitors or tricyclic antidepressants may increase the effects of either medication. Hysingla ER should not be used while pregnant or breastfeeding. Patients with severe hepatic impairment or moderate to severe renal impairment should receive half the initial dose and should be monitored closely for adverse effects. The most common adverse reactions (≥5%) are constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence.1
Dr. Holmberg earned her PharmD from the University of Connecticut and completed an ambulatory care residency at the Phoenix VA Healthcare System. Her practice has also included pediatrics and inpatient mental health. She resides in Phoenix, Arizona.
1. Hysingla ER [package insert]. www.purduepharma.com/wp-content/uploads/hysinglaerpi.pdf. Accessed December 2014.
2. Purdue Pharma LP receives FDA approval for Hysingla ER (hydrocodone bitartrate) extended-release tablets CII, a once-daily opioid analgesic formulated with abuse-deterrent properties. www.purduepharma.com/news-media/2014/11/purdue-pharma-l-p-receives-fda-approval-for-hysinglatm-er-hydrocodone-bitartrate-extended-release-tablets-cii-a-once-daily-opioid-analgesic-formulated-with-abuse-deterrent-properties. Accessed December 2014.
3. FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm423977.htm. Accessed December 2014.