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
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OROBUPRE has been granted a marketing authorisation for the treatment of opiate addiction.
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It is a buprenorphine-based orodispersible tablet administered on the tongue, not sublingually as for SUBUTEX.
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It dissolves more rapidly than SUBUTEX.
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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.
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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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