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BEMA Buprenorphine

Phase 3

Pain | Small molecule | Musculoskeletal |Collegium Pharmaceutical, Inc.|Last Updated: Aug 7, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment302

FDA Designations

No designations recorded

Clinical trial landscape

BEMA Buprenorphine · 1 trial · 4 indications

Phase 3 1
NCT01298765Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic PainPain
COMPLETED302 Analytics
PHASE3COMPLETED
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain
Pain
NCT01298765302
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Study Endpoints

Primary Endpoints

Change From Baseline in NRS Pain Intensity
Baseline up to approximately Week 52

The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and used to calculate the change from baseline at week 52.

Secondary Endpoints

Patient Global Impression of Change in Pain Intensity
Baseline to Week 28
Treatment Satisfaction Questionnaire for Medication/Global Satisfaction
Baseline to Week 28
Subjects Overall Satisfaction With Study Drug
Baseline to Week 52
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BEMA BuprenorphineEXPERIMENTALbuprenorphine buccal soluble film

Interventions

NameTypeDescription
BEMA BuprenorphineDRUGbuccal soluble film; applied to the buccal mucosa twice daily
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Male or non-pregnant and non-nursing female aged 18 or older * History of moderate to severe chronic pain: 1. Subjects completing study BUP-301 (low back pain) or 2. Osteoarthritis or neuropathic pain, or subjects not completing study BUP-301 (low back pain), pain for ≥3 ...

Countries:United States
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Frequently asked questions about BEMA Buprenorphine

What is BEMA Buprenorphine used for?

BEMA Buprenorphine is an investigational small molecule being developed for the treatment of pain, including chronic pain conditions such as low back pain, osteoarthritis, and neuropathic pain. It is a buccal film formulation of buprenorphine, designed to deliver the medication through the lining of the cheek.

Who makes BEMA Buprenorphine?

BEMA Buprenorphine is being developed by Collegium Pharmaceutical, Inc., a company traded on the stock exchange under the ticker symbol COLL. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for pain management.

What phase is BEMA Buprenorphine in?

BEMA Buprenorphine is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for treating chronic pain.

What clinical trials is BEMA Buprenorphine in?

BEMA Buprenorphine has one completed Phase 3 clinical trial, identified as NCT01298765. This study, titled "Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain," enrolled 302 participants in the United States and evaluated the long-term safety of the drug in patients with pain, low back pain, osteoarthritis, and neuropathic pain.

Is BEMA Buprenorphine FDA approved?

BEMA Buprenorphine is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The completed clinical trial, NCT01298765, was a long-term safety study, but the drug has not yet received regulatory approval for the treatment of chronic pain.