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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