Is Symproic a controlled substance?

Q: Is Symproic a controlled substance?

No. Symproic (naldemedine) is not a controlled substance. What is Symproic? Symproic is a prescription medicine belonging to the class of drugs called opioid antagonists . Symproic is used in adults with chronic non-cancer pain to treat a type of constipation called opioid-induced constipation (OIC) that is caused by prescription pain medicines called opioids. Was Symproic previously a Schedule II drug? Yes. When Symproic was first approved by the FDA in March 2017, it was placed in Schedule II of the Controlled Substances Act (CSA) because of the structural similarity of the active ingredient naldemedine to naltrexone. Drugs in Schedule II have an accepted medical use, but also have a high potential for abuse, which may lead to drug seeking behaviors and dependence. Examples of Schedule II substances include morphine, cocaine, hydrocodone, fentanyl, and methamphetamine. The manufacturer Shionogi Inc. submitted a petition for the descheduling of Symproic to the DEA. In September 2017, naldemedine was removed from Schedule II after the DEA determined that naldemedine did not meet the requirements for inclusion in any CSA schedule.

Medically reviewed by Judith Stewart, BPharm. Last updated on Feb 12, 2025.

Official Answer by Drugs.com

No. Symproic (naldemedine) is not a controlled substance.

What is Symproic?

Symproic is a prescription medicine belonging to the class of drugs called opioid antagonists.

Symproic is used in adults with chronic non-cancer pain to treat a type of constipation called opioid-induced constipation (OIC) that is caused by prescription pain medicines called opioids.

Was Symproic previously a Schedule II drug?

Yes. When Symproic was first approved by the FDA in March 2017, it was placed in Schedule II of the Controlled Substances Act (CSA) because of the structural similarity of the active ingredient naldemedine to naltrexone.

Drugs in Schedule II have an accepted medical use, but also have a high potential for abuse, which may lead to drug seeking behaviors and dependence. Examples of Schedule II substances include morphine, cocaine, hydrocodone, fentanyl, and methamphetamine.

The manufacturer Shionogi Inc. submitted a petition for the descheduling of Symproic to the DEA. In September 2017, naldemedine was removed from Schedule II after the DEA determined that naldemedine did not meet the requirements for inclusion in any CSA schedule.

References

U.S. Food and Drug Administration (FDA) SYMPROIC Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s000lbl.pdf [Accessed February 22, 2021]
U.S. Food and Drug Administration (FDA) SYMPROIC Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208854s002lbl.pdf [Accessed February 22, 2021]
U.S. Department of Justice Drug Enforcement Administration (DEA). Drugs of Abuse 2017 Edition. Available at https://www.dea.gov/sites/default/files/drug_of_abuse.pdf [Accessed February 22, 2021]
U.S. Department of Justice Drug Enforcement Administration (DEA). Federal Register Notices- Rules 2017. Available at https://www.deadiversion.usdoj.gov/fed_regs/rules/2017/fr0929.htm [Accessed February 22, 2021]

Is Symproic a controlled substance?

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