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Buprenorphine fast dissolving

Phase 2

Opioid Dependency | Small Molecules | Psychiatry |Supernus Pharmaceuticals, Inc.|Trials Updated: Apr 11, 2023

Buprenorphine fast dissolving target and mechanism

Molecular targetOPRK1, OPRM1
Target classAgonist
ModalitySmall Molecules
ChEMBLCHEMBL511142

Also known as Buprenorphine hydrochloride fast dissolving tablet (FDT)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Buprenorphine fast dissolving clinical trials

Buprenorphine fast dissolving · 1 trial · 1 indication

Phase 2 1
NCT01075971Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED)Opioid Dependency
COMPLETED52 Analytics
PHASE2COMPLETED
Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED)
Opioid Dependency
NCT0107597152
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Study Endpoints

Primary Endpoints

The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy.
Daily, Day 1 to Day 5

Patient's overall satisfaction on Day 1 to Day 5 postdose. Marketed sublingual tablet (Marketed SL): Days 1 and 2; Fast dissolving tablet (FTD): Days 3, 4, and 5. Within 1 hour after complete dissolution of the tablet(s), overall satisfaction towards the study treatment was to be scored by the patient himself / herself using a 10-cm visual analogic scale (VAS) ranging from "Not at all satisfied" (score = 0) to "Totally satisfied" (score = 10).

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Buprenorphine hydrochlorideEXPERIMENTAL -

Interventions

NameTypeDescription
Buprenorphine hydrochloride marketed sublingual tablet (Subutex)DRUG8 mg or 16 mg daily, sublingual route on Days 1 and 2
Buprenorphine hydrochloride fast dissolving tablet (FDT)DRUG8 mg or 16 mg daily, sublingual route on Days 3, 4, and 5
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. * Patients must be at least (≥) 18 years of age, of either sex. * Patients treated for opioid dependence with Subutex®, with a stable d...

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Other drugs targeting OPRK1

naltrexone ALKS· PHASE3 Naltrexone ALKS· PHASE3 Samidorphan ALKS· PHASE2 difelikefalin CARA· PHASE2 Buprenorphine COLL· PHASE3 naloxone AP003 EBS· PHASE1 Difelikefalin FMS· PHASE3 Aticaprant JNJ· PHASE3 Aticaprant Supratherapeutic Dose JNJ· PHASE1 Buprenorphine Injectable- Part A SUPN· PHASE1 Buprenorphine soluble film SUPN· PHASE2 Buprenorphine TEVA· PHASE1

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