The Drug Enforcement Agency (DEA) has proposed a rule to deschedule naldemedine, an opium alkaloid derivative, removing it from control under the Controlled Substances Act (CSA).
Naldemedine is a high affinity antagonist at the mu, kappa, and delta opioid receptors. Recently, Shionogi and Purdue received Food and Drug Administration (FDA) approval for naldemedine (Symproic) in the treatment of opioid-induced constipation in adults with chronic non-cancer pain.
The manufacturers had submitted a petition to the DEA to have the drug removed from all schedules for control under the CSA. After an extensive review, the DEA has concluded that naldemedine has no potential for abuse and does not meet the findings for control under any CSA schedule; has a currently accepted medical use in the United States; and does not have physical or psychological dependence potential.
As to the potential risks to public health, the DEA writes that the possibility of abuse is very unlikely, as is the risk of cardiotoxicity. In addition, no symptoms of physical dependence were observed with naldemedine both during drug administration and seven days after discontinuing the drug.
If finalized, the proposed rule will affect all persons who would handle, or propose to handle, naldemedine.
Symproic, which is anticipated to launch sometime this summer, will be available as 0.2mg strength tablets.
For more information visit FederalRegister.gov.