Arymo

Arymo: the abuse-deterrent prescription painkiller

abuse deterrent Arymo
Drug overdose is the number one cause of accidental death in the United States.

There were 55,403 lethal overdoses in 2015 alone, compared to 31,595 deaths due to unintentional falls, 35,398 motor-vehicle-accident-related deaths, and 586 accidental firearm-related deaths, all in 2014. Of these overdose-related deaths, 33,091 were caused by opioids. Compare the numbers, and you can see why there is cause for alarm.

Pharmaceutical companies are stepping up in response. One company in particular, Egalet, has recently developed a drug for pain relief that implements new technology to prevent abuse. It’s called Arymo, and we’ve compiled the current research on it here.

What is Arymo?

Arymo is a new type of extended-release morphine sulfate to be used for round-the-clock pain management. There are many medications created for this purpose, but Arymo uses Guardian technology, which is specific to Egalet, that creates a physical and chemical barrier to deter abuse. Since morphine is a Schedule II opiate, this type of technology has special implications.

Guardian technology is different from other medications in that it does not use opioid antagonists — drugs that resemble the structure of opioids but do not activate their receptors, blocking the effects of opioids. Instead, the shell of the pill is made before the medication itself is injected into the center, making it difficult to cut, crush, grind, or break.

The FDA’s advisory panel originally voted 18-1 for Egalet to state that Arymo deters abuse orally, nasally, and intravenously, but the FDA itself overruled the advisory panel. Instead, Egalet can state that it deters abuse for people looking to dissolve the morphine and inject it; another medication (MorphaBond, another form of extended release morphine) has marketing exclusivity on nasal deterrence until 2018. It is unclear why the FDA chose to rule against the claim of oral deterrence.

Three strengths —15mg, 30mg, and 60mg— have been approved and the commercial launch will come in the first quarter of 2017.

What are the side effects?

The most common side effects observed in clinical trials include:

  • Constipation.
  • Dizziness.
  • Dysphoria.
  • Euphoric mood.
  • Nausea.
  • Sedation.
  • Sweating.
  • Vomiting.

Less common reactions included:

  • Abdominal pain.
  • Anorexia.
  • Blurred vision.
  • Brachycardia.
  • Chills.
  • Diarrhea.
  • Double-vision.
  • Dry mouth.
  • Headaches.
  • Heart palpitations.
  • Hypertension.
  • Hypotension.
  • Fainting.
  • Mood changes, such as anxiety and depression.
  • Muscle rigidity or twitching.
  • Rash.
  • Tachycardia.
  • Visual impairments.
  • Weakness.

Arymo and pregnancy

Using opioids during pregnancy can cause neonatal opioid withdrawal syndrome, a group of issues that affect a baby born to a mother who used opioids during pregnancy. Symptoms of this include:

  • Blotchy skin.
  • Diarrhea.
  • Excessive or high-pitched crying.
  • Excessive sucking.
  • Hyperactive reflexes.
  • Irritability.
  • Poor feeding.
  • Rapid breathing.
  • Sleep problems.
  • Trembling.
  • Trouble gaining weight.
  • Vomiting.

This syndrome goes away once withdrawal eases, but some babies might need medication like methadone or buprenorphine to help deal with withdrawal symptoms.

There haven’t been any studies done on pregnant women who have used Arymo and their children, but studies on morphine and pregnancy haven’t shown a clear association between morphine and congenital disabilities. Animal studies have shown an association between morphine and neural tube defects, lower baby weight, and increased risk of spontaneous abortion.

Speak to your doctor before taking Arymo if you are pregnant or are thinking of becoming pregnant.

Potential dangers

People who live with the following should speak to their doctor before taking Arymo:

  • Chronic pulmonary disease.
  • Gastrointestinal obstructions.
  • Increased intracranial pressure.
  • Recent head injury.
  • Seizure disorders.
  • Severe bronchial depression.
  • Severe/acute bronchial asthma without resuscitative equipment.

People who take the following should not take Arymo:

  • Benzodiazepines.
  • Central nervous system (CNS) depressants.
  • MAOI inhibitors.

Regardless of whether or not you find yourself in the position of deciding whether or not to take Arymo, the implications of Guardian technology are exciting. Hopefully, the matter of prescription opioid abuse can be solved or curtailed soon with this innovation and others like it.

“Accidents or Unintentional Injuries.” National Center for Health Statistics. Centers for Disease Control and Prevention, 15 September 2016. 23 January 2017. <https://www.cdc.gov/nchs/fastats/accidental-injury.htm>. Anderson, Pauline. “FDA Okays Morphine Sulfate (Arymo ER) for Chronic Pain.” Medscape Medical News. Medscape, 10 January 2017. 23 January 2017. <http://www.medscape.com/viewarticle/874245>. “FULL PRESCRIBING INFORMATION: Arymo ER.” U.S. Food & Drug Administration, January 2017. 23 January 2017. <http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208603s000lbl.pdf>. “Impact of Exclusivity on Approval of Arymo ER.” Drug Safety and Availability. U.S. Food & Drug Administration, 9 January 2017. 23 January 2017. <http://www.fda.gov/Drugs/DrugSafety/ucm535708.htm>. Lee, MD, MSc, IBCLC., Kimberly G. “Neonatal abstinence syndrome.” Medical Encyclopedia. MedlinePlus, 3 November 2015. 23 January 2017. <https://medlineplus.gov/ency/article/007313.htm>. McQuade, Dan. “Why the FDA Approved Local Firm’s Abuse-Deterrent Opioid.” Business. Philadelphia Magazine, 17 January 2017. 23 January 2017. <http://www.phillymag.com/business/2017/01/17/why-the-fda-approved-local-firms-abuse-deterrent-opioid/>. “Opioid Addiction: 2016 Facts & Figures.” American Society of Addiction Medicine, 2016. 23 January 2017. <http://www.asam.org/docs/default-source/advocacy/opioid-addiction-disease-facts-figures.pdf>. “Opioid Antagonist.” Medical Dictionary. The Free Dictionary, 2017. 23 January 2017. <http://medical-dictionary.thefreedictionary.com/opioid+antagonist>.
Arymo: the abuse-deterrent prescription painkiller
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