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(Reuters) - British drugmaker Indivior Plc said on Tuesday it applied for a new drug application to the U.S. Food and Drug Administration to market its drug to treat opioid use disorder (OUD).
The drug, RBP-6000, is a monthly injectable opioid, used to treat OUD as a part of a treatment plan that includes counseling and psychological support, Indivior said.
OUD is characterized by a compulsive use of opioid substances, when they are taken in excessive amounts, often serving no medical purpose.
About 4.3 million Americans engaged in non-medicinal use of painkillers including opioids, while 1.9 million met the criteria for painkiller use disorder, Indivior said.
Opioid abuse, overdose and addiction have assumed epidemic proportions in the United States, partly due to unrestricted prescription of narcotic painkillers as well as the paucity of access to substance-abuse treatment programs.
Reporting by Sanjeeban Sarkar in Bengaluru; Editing by Sai Sachin Ravikumar