PMID- 28268215
OWN - NLM
STAT- MEDLINE
DCOM- 20180424
LR  - 20180424
IS  - 1421-9891 (Electronic)
IS  - 1022-6877 (Linking)
VI  - 23
IP  - 2
DP  - 2017
TI  - Randomised Comparison of a Novel Buprenorphine Oral Lyophilisate versus Existing 
      Buprenorphine Sublingual Tablets in Opioid-Dependent Patients: A First-in-Patient 
      Phase II Randomised Open Label Safety Study.
PG  - 61-70
LID - 10.1159/000456612 [doi]
AB  - AIMS: To test the safety of new buprenorphine oral lyophilisate wafer ("bup-lyo") 
      versus standard sub-lingual buprenorphine ("bup-SL"). DESIGN: Randomised (2:1) 
      open-label study; opioid-dependent subjects; subsequent partial cross-over. 
      SETTINGS: Specialised clinical trials facility and addictions treatment facility. 
      PARTICIPANTS: Opioid-dependent subjects (n = 36) commencing buprenorphine 
      maintenance (personalised dose-titration) including patients co-using alcohol, 
      cocaine and benzodiazepines (below thresholds). MEASUREMENTS: Respiratory 
      function (respiratory rate, pulse-oximetry); medication hold and dose adequacy; 
      opiate withdrawal signs and symptoms; tablet disintegration times; treatment 
      retention. Pharmacokinetics (PK) for plasma buprenorphine and norbuprenorphine (n 
      = 11). FINDINGS: Oral lyophilised buprenorphine ("bup-lyo") completely dissolved 
      within 2 min for 58 vs. 5% for "bup-SL." Dose titration resulted in similar 
      maintenance dosing (10.8 vs. 9.6 mg). There were no significant between-group 
      differences in opiate-withdrawal phenomena, craving, adequacy of "hold," 
      respiratory function. No serious adverse events (AEs), nor "severe" AEs, although 
      more AEs and Treatment-Emergent AEs with "bup-lyo" (mostly "mild"). PK found 
      greater bioavailability of buprenorphine with "bup-lyo" (but not 
      norbuprenorphine). CONCLUSIONS: Orally disintegrating buprenorphine oral 
      lyophilisate wafer disintegrated rapidly. No increased respiratory depression was 
      found and clinically no difference between medications was observed. PK found 
      substantially increased bioavailability of buprenorphine (but not of 
      nor-buprenorphine) with "bup-lyo" relative to "bup-SL." In supervised dosing 
      contexts, rapidly disintegrating formulations may enable wider buprenorphine 
      prescribing.
CI  - (c) 2017 S. Karger AG, Basel.
FAU - Strang, John
AU  - Strang J
AD  - King's College London, National Addiction Centre, Institute of Psychiatry, 
      Psychology and Neuroscience, London, UK.
FAU - Reed, Kylie
AU  - Reed K
FAU - Bogdanowicz, Karolina
AU  - Bogdanowicz K
FAU - Bell, James
AU  - Bell J
FAU - van der Waal, Rob
AU  - van der Waal R
FAU - Keen, Jenny
AU  - Keen J
FAU - Beavan, Pete
AU  - Beavan P
FAU - Baillie, Shelagh
AU  - Baillie S
FAU - Knight, Alastair
AU  - Knight A
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170308
PL  - Switzerland
TA  - Eur Addict Res
JT  - European addiction research
JID - 9502920
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Tablets)
RN  - 40D3SCR4GZ (Buprenorphine)
RN  - 7E53B4O073 (norbuprenorphine)
SB  - IM
MH  - Analgesics, Opioid/adverse effects
MH  - Buprenorphine/*administration & dosage/*analogs & derivatives
MH  - Drug Administration Routes
MH  - Female
MH  - Humans
MH  - Opiate Substitution Treatment/*methods
MH  - Opioid-Related Disorders/*drug therapy
MH  - Tablets
OTO - NOTNLM
OT  - Buprenorphine
OT  - Lyophilised
OT  - New treatment
OT  - Opiate addiction
OT  - Opioid substitute therapy
OT  - Phase II trial
OT  - Randomised trial
OT  - Rapidly-disintegrating buprenorphine
OT  - Safety study
EDAT- 2017/03/08 06:00
MHDA- 2018/04/25 06:00
CRDT- 2017/03/08 06:00
PHST- 2016/08/09 00:00 [received]
PHST- 2017/01/14 00:00 [accepted]
PHST- 2017/03/08 06:00 [pubmed]
PHST- 2018/04/25 06:00 [medline]
PHST- 2017/03/08 06:00 [entrez]
AID - 000456612 [pii]
AID - 10.1159/000456612 [doi]
PST - ppublish
SO  - Eur Addict Res. 2017;23(2):61-70. doi: 10.1159/000456612. Epub 2017 Mar 8.