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Novel Abuse-Deterrent Morphine Approved

Darrell Hulisz, RPh, PharmD
Zachary Brock

March 1, 2017

The FDA recently approved Arymo ER (morphine sulfate extended-release) a novel abuse-deterrent opioid for chronic pain. Long-acting morphine in an abuse-deterrent formulation will decrease the ability of abusers to use the medication by injectable route. Of note, the FDA claims that intranasal, oral, and intravenous route abuse is still possible. The medication is labeled to treat severe pain that requires daily, around-the-clock therapy when other treatment choices are insufficient.

The features offered by Arymo ER are intended to target those who misuse or abuse prescription opioids. Opioid abusers often seek immediate-release (IR) formulations due to the rapid increase in opioid blood levels that produce the psychoactive effects. Some abusers have even manipulated the extended-release (ER) formulations into an IR-like form to get larger concentrations of the opioid. According to data from 2015, morphine is actually the most common ER opioid prescribed, so this could affect a significant portion of the population. The abuse-deterrent formulations (ADFs) are designed to create difficulty in the misuse and abuse process and support the current public health crisis.

Egalet Corporation, a specialty pharmaceutical company, created Arymo via Guardian™ Technology (abuse-deterrent properties) and the product is available as 15, 30, and 60 mg tablets. The Guardian Technology consists of polymer matrix tablet technology which supports the manufacturing of these pharmaceutical products. The properties of the tablet technology involve chemical and physical barriers that assist in deflecting manipulation, both simple and laborious methods.

These tablets encompass quite a few qualities that help to decrease abuse potential; resistance to particle size reduction (PSR), partial inhibition at chemical withdrawal of the active pharmaceutical ingredient (API), and lastly, the tablets themselves are extremely hard. Interestingly, when the product is in contact with liquid, it results in a viscous hydrogel that therefore makes it difficult to draw into a syringe as well. Chewing/crushing and snorting are unlikely due to the hardness of the tablet and the resistance to particle size reduction, respectively. Also, smoking methods are difficult due to the poor combustion properties. Most notably, isolating morphine from Arymo ER due to the hydrophilic nature and the gelling upon contact with liquid makes it difficult for individuals to inject themselves with the product. These abuse-deterrent properties could be very useful in situations where prescribers feel drug abuse is an existing problem with the patient or those with access to the patient's medications.

A majority of ER opioid products can be abused and/or diverted; thus, it is helpful for healthcare professionals to have additional treatment options, such as Arymo ER, that are resistant to chemical and/or mechanical manipulation. Arymo ER should be commercially available in the late first quarter this year. As of June 30, 2016 there have been six FDA-approved opioids that are abuse-deterrent, including a reformulated OxyContin. The technology has certainly come a long way and is very beneficial in regards to our pandemic of opioid abuse.