OROBUPRE (buprenorphine), medicine used in cases of opiate dependence

ADDICTOLOGY - New medicinal product
Opinions on drugs - Posted on Feb 22 2019

Reason for request

Inclusion

Moderate clinical benefit in the replacement therapy of addiction to opiates, but no demonstrated clinical advantage over SUBUTEX

 

  • OROBUPRE has been granted a marketing authorisation for the treatment of opiate addiction.

  • It is a buprenorphine-based orodispersible tablet administered on the tongue, not sublingually as for SUBUTEX.

  • It dissolves more rapidly than SUBUTEX.

  • It is not interchangeable with other buprenorphine-containing medicinal products due to its different bioavailability, complicating the implementation of replacement therapy and exposing patients to a risk of overdosage. 

  • Its use is not appropriate in patients stabilised with sublingual buprenorphine at doses below 2 mg as lower dosages are not available.

 

 


Clinical Benefit

Moderate

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Clinical Added Value

no clinical added value

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