Long-term Extension Study of BEMA™ Fentanyl

BioDelivery Sciences International

Status and phase

Completed

Phase 3

Conditions

Respiratory Depression

Treatments

Drug: BEMA Fentanyl

Study type

Interventional

Funder types

Industry

Identifiers

NCT00696137

FEN-290

Details and patient eligibility

About

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.

Full description

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
there is evidence of improper use of the study drug.