FDA Approves Implantable Device for Steady Release of Buprenorphine

Buprenorphine, unlike oxycodone and heroin, is a partial opioid receptor agonist. This property confers this drug a number of advantages over other opioid analogs: it has less potential for euphoria, physical dependence and misuse, a mild withdrawal profile, and provides a ceiling on opioid effects. Buprenorphine is therefore thought of as a drug of choice to treat opioid addiction.

Thus, when adequately prescribed, buprenorphine is effective in suppressing major symptoms of opioid withdrawal, reducing cravings for opioids, and in blocking the effects of other opioids. Patients have also been found to be compliant.

 

On May 26, 2016, The US Food and Drug (FDA) approved Probuphine¹, a buprenorphine implant to treat opioid dependence, developed by Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals in Princeton, New Jersey. This implant, unlike current treatment options (daily pill or dissolvable and ingestible film), provides a continuous dose of buprenorphine over a 6 month period for patients already on a stable buprenorphine regimen.

The Department of Health and Human Services announced in a communiqué in March 2015, the launch of an Opioid Initiative², one of its top 3 priorities, and aimed at reducing opioid overuse in the US in order to prevent related overdose, death and dependence. The FDA’s correlate, the Opioids Action Plan³, emphasizes the need to ramp up use of medication-assisted treatments.

Such maintenance treatments with extended-release injection of the opioid antagonist naltrexone, have proven very effective when paired with behavioral therapy, including psychosocial support and recovery support services, according to the Substance Abuse and Mental Health Services Administration (SAMHSA)⁴.

Probuphine, which consists of 4 rods, each 1 inch in length, requires minor surgical intervention to subcutaneously implant it in the upper arm. Its recent FDA approval for use as a treatment option for opioid dependence followed a randomized clinical trial in which 63% of participants did not exhibit illicit opioid use during the 6 month period of treatment.

Common side effects include pain at site of implantation, itching, but also depression, nausea, and back and oropharyngeal pain.

 

References

1.Probuphine https://braeburnpharmaceuticals.com/titan-pharmaceuticals-and-braeburn-pharmaceuticals-announce-fda-advisory-committee-recommends-approval-of-probuphine-first-6-month-implant-to-treat-opioid-addiction/

2.HHS’ Opioid Initiative http://www.hhs.gov/about/news/2015/03/26/hhs-takes-strong-steps-to-address-opioid-drug-related-overdose-death-and-dependence.html

3.FDA’a Opioids Action Plan: http://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm484714.htm

4.SAMHSA’s treatments for substance use disorders: http://www.samhsa.gov/treatment/substance-use-disorders