FDA Approves Monthly Injection For Opioid Addiction

FDA Approves Monthly Injection For Opioid Addiction

By Aisha Al-Muslim and Jeanne Whalen,

The U.S. Food and Drug Administration approved for sale a monthly injection to treat addiction to heroin and other opioids, the latest medication to hit the market to combat the crisis of opioid abuse and overdose deaths.

 

The injection, called Sublocade, contains buprenorphine, a generic drug that eases cravings for opioids and stops the painful withdrawal symptoms that keep many addicts addicted. The product is the first once-a-month buprenorphine injection on the market for the treatment of moderate-to-severe opioid use disorder.

 

U.K. drugmaker Indivior INDV 3.02% PLC and the FDA announced the approval late Thursday. Sublocade is expected to be available in the U.S. in the first quarter of 2018.

 

Sublocade is intended to be administered by health-care providers and as part of a treatment program that includes counseling and psychosocial support, Indivior said in a statement.

 

“With the approval today of a monthly formulation of the drug buprenorphine for the treatment of opioid use disorder, patients have access to a new and longer-acting option for the treatment of opioid addiction,” FDA Commissioner Scott Gottlieb said in a statement. He added that the FDA is “taking a more active role in supporting wider adoption” of drugs such as buprenorphine for the treatment of opioid addiction.

The Food and Drug Administration campus in Silver Spring, Md.
The Food and Drug Administration campus in Silver Spring, Md. PHOTO: ANDREW HARNIK/ASSOCIATED PRESS

The monthly injection is the latest version of buprenorphine to hit the market. Buprenorphine is itself an opioid that partially activates the same cellular receptors in the brain that heroin and other opioids do, thus blocking painful withdrawal symptoms.

 

Other forms of buprenorphine on the market can be taken orally each day as tablets or films that melt in the mouth. Many patients have benefited from those drugs, but they sometimes run out of doses or skip them. Some also sell their daily doses on the black market to other addicts, a trend that has troubled public-health officials.

 

A monthly injection would make such black-market sales impossible. The FDA last year also approved a long-acting implant that, once inserted in the arm, emits buprenorphine for six months.

 

Indivior said the U.S. wholesale price of the Sublocade injection will be $1,580 a month. Indivior already sells an oral version of buprenorphine called Suboxone, which has a U.S. wholesale price that can range from about $230 to about $470 a month, depending on the dose, according to data provider Elsevier.

 

The opioid addiction epidemic in the U.S. is a national public health emergency, with an average of 91 Americans dying every day from an opioid overdose, according to the Centers for Disease Control and Prevention. From 2000 to 2015 more than half a million people died from drug overdoses.

“The urgency for this new treatment has never been greater, as the U.S. opioid crisis has been declared a national public health emergency,” Indivior Chief Executive Shaun Thaxter said in prepared remarks. “Sublocade’s approval is an important step forward for patients, families and communities battling the opioid epidemic.”

The contents of an emergency opioid overdose kit is displayed on a table. The U.S. Food and Drug Administration approved Sublocade, an injection for the treatment of opioid addiction.

Write to Aisha Al-Muslim at aisha.al-muslim@wsj.com and Jeanne Whalen at jeanne.whalen@wsj.com

Reference: WSJ

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