FDA Statement Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments

by | Addiction

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587315.htm?utm_campaign=11302017_Statement_Following%20bunep%20release&utm_medium=email&utm_source=Eloqua

FDA Commissioner Scott Gottlieb, MD

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. Millions of Americans are suffering from addiction to opioid drugs, and millions more are worried that the overdose epidemic could claim the lives of a friend or loved one. We need immediate actions to help those suffering from an opioid use disorder transition to lives of sobriety.

An urgent need is broad access to high-quality, effective treatment. The President’s Commission on Combating Drug Addiction and the Opioid Crisis found that treatment of opioid addiction that includes medications “has been associated with reduced overdose deaths, retention of persons in treatment, decreased heroin use, reduced relapse, and prevention of the spread of infectious disease.”

Medication-assisted treatment (MAT) for opioid addiction uses drugs to stabilize brain chemistry, reduce or block the euphoric effects of opioids, relieve physiological cravings and normalize body functions. There are three drugs approved by the FDA for the treatment of opioid addiction: buprenorphine, methadone and naltrexone. All three of these treatments have been demonstrated to be safe and effective in combination with counseling and psychosocial support. Everyone who seeks treatment for an opioid use disorder should be offered access to all three options. This allows providers to work with patients to select the treatment best suited to a patient’s individual needs.

Indivior Submits New Drug Application to U.S. FDA for RBP-6000 Buprenorphine Monthly Depot

05.30.2017

http://www.indivior.com/investor-news/indivior-submits-new-drug-application-u-s-fda-rbp-6000-buprenorphine-monthly-depot/

Comment;

It will be great when long-acting BUP hits the market.  I just hope it’s affordable and covered by managed care organizations!

 

Dr. Raymond Oenbrink
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