New Abuse-Deterrent Opioid Formulations Released

The Food and Drug Administration (FDA) released a notice in 2013, surrounding the long-time available acetaminophen (the active ingredient in brands like Tylenol®). This notice addressed two issues that would help to make acetaminophen-containing products safer for the ultimate consumer by limiting their exposure and drawing a connection to their risks. The first was a call to limit the amount of acetaminophen in prescription combination products to 325mg per tablet, capsule or other unit of dose. The second required updated labeling to include liver toxicity warning. This bulletin gave the manufacturers until January 14, 2014, to comply by removing medications containing more than 325mg of acetaminophen from the market.

Prescription combination products containing acetaminophen are frequently prescribed for workers’ compensation injuries, most commonly those with opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet®) and hydrocodone (Vicodin™, Norco®). As a result of the FDA restriction on acetaminophen, manufacturers reformulated their combination acetaminophen products (i.e. Vicodin 5/500mg (hydrocodone/acetaminophen immediate release) tablet to Vicodin 5/300mg). Other manufacturers began releasing new opioid products containing no acetaminophen (i.e. Zohydro® ER, Hysingla® ER, both hydrocodone extended release formulations).

With these new releases came concerns. Critics of the new single opioid formulations feared they would lead to more abuse, misuse, and deaths due to the removal of the acetaminophen. In other words, excessive use of acetaminophen would no longer be a deterrent for patients tempted to take the medications at higher doses than prescribed and it remained to be seen what steps would be taken by manufacturers to guard against abuse and misuse of these products. As part of the FDA’s strategy to address the opioid abuse epidemic, they encouraged manufacturers to produce abuse-deterrent formulations.

Recently there have been several new single opioid formulation products, containing no acetaminophen, approved by the FDA and released to the market. All have some form of abuse-deterrent property.

Arymo™ ER (morphine sulfate extended release) abuse-deterrent tablet: FDA approved for the treatment of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment. Available in 15mg, $5.18/tab*, 30mg, $10.38/tab*, and 60mg, $20.76/tab* strengths.

Vantrela™ ER (hydrocodone bitartrate extended-release) abuse-deterrent tablet: FDA approved for the treatment of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment. Available in 15mg, 30mg, 45mg, 60mg, and 90m strengths.

Xtampza® ER (oxycodone hydrochloride extended-release) abuse-deterrent capsule: FDA approved for the treatment of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment. Available in 9mg, $4.42/capsule*, 13.5mg, $6.51/capsule*, 18mg, $8.26/capsule*, 27mg, $11.49/capsule, and 36mg, $14.15/capsule*strengths.

Troxyca® ER (oxycodone hydrochloride/naltrexone hydrochloride extended-release) abuse-deterrent tablet: FDA approved for the treatment of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment. Available in 10mg/1.2mg, 20mg/2.4mg, 30mg/3.6mg, 40mg/4.8mg, 60mg/7.2mg and 80mg/9.6mg strengths.

Roxybond™ (oxycodone hydrochloride immediate-release) abuse-deterrent tablet: FDA approved for the treatment of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Available in 5mg, 15mg, and 30mg tablets.

*Centers for Medicare and Medicare Services (CMS) pricing utilized if available. Pricing at time of this article was not available in Redbook or CMS portal for all other medications.

Even though these abuse-deterrent formulations will not prevent consumption of large doses of opioids, the most common method of abuse, they do have one or more properties that make their non- therapeutic use less rewarding and more difficult. All, except Troxyca, utilize a physical and chemical barrier to deter abuse by cutting, crushing, grinding, or breaking for intravenous or intranasal use, while Troxyca utilizes the addition of an opiate antagonist to block the patient from experiencing the opiate effects of the medication.

Opioids have a long history of being utilized to treat pain in workers’ compensation injuries and while they are considered safe and effective when properly utilized they also have a high potential to lead to abuse, misuse, and addiction. This can lead to health risks for the injured worker and increased medical expenses over the life of the claim for the carrier. Therefore, it is imperative that carriers and Third Party Administrators (TPAs) take proactive measures to quickly get control of cases where they suspect fraud, misuse, and abuse in the early stages of the patient’s treatment. However, even at the final stage of the claim when the patient is rendered to be at MMI (Maximum Medical Improvement) and settlement is being discussed, there is still an opportunity to take advantage of clinical programs available to address inappropriate narcotic prescribing or abuse and misuse at the time. Optum Settlement Solutions offers a variety of clinical products and has a vast staff of pharmacists and nurses to assist clients with a plan to render the most cost effective treatment for the injured worker while allowing for the best therapeutic outcome.

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