Long-term Extension Study of BEMA™ Fentanyl

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-07-31

Brief Summary

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This study is designed to provide continued access to BEMA Fentanyl for those subjects who previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the treatment of their breakthrough cancer pain.

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Detailed Description

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This was an open label, long-term, extension study designed to provide continued access to EMA Fentanyl to those patients with breakthrough cancer pain who were treated for at least 2 weeks in FEN-202, the long term safety study used for worldwide registration. Patients were followed in an outpatient setting. Use of BEMA Fentanyl and occurrence of serious adverse events (SAEs) were monitored. Throughout the study, all patients continued their background opioid regimen and were permitted to use their rescue medication if adequate pain relief was not realized within 30 minutes following application of BEMA Fentanyl.

Conditions

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Respiratory Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BEMA Fentanyl

Group Type EXPERIMENTAL

BEMA Fentanyl

Intervention Type DRUG

buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily

Interventions

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BEMA Fentanyl

buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily

Intervention Type DRUG

Other Intervention Names

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bioerodible mucoadhesive fentanyl buccal soluble film ONSOLIS

Eligibility Criteria

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Inclusion Criteria

1. previously qualified for and participated in study FEN-202 for at least 2 weeks,
2. wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and
3. provide signed informed consent at screening prior to any study procedures.

Exclusion Criteria

1. they have developed a new medical condition after initial enrollment in FEN-202 which, in the opinion of the investigator, would preclude safe and appropriate use of BEMA Fentanyl or participation in this study, or
2. there is evidence of improper use of the study drug.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No