Conditions: Respiratory Depression
Keywords: Chronic Pain Ventilatory Response to Hypercapnia (VRH)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 5
Healthy volunteers: no

Brief summary:
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.

Detailed 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.

Arms:
arm 1: BEMA Fentanyl

Interventions: intervention 1: BEMA Fentanyl
Intervention descriptions: intervention 1: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily

Protocol document: