Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Oral Transmucosal Fentanyl Citrate (OTFC) is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. FDA label
Also known as ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]), ACTIQ (Oral transmucosal fentanyl citrate)
ACTIQ · 3 trials · 5 indications
| Name | Type | Description |
|---|---|---|
| ACTIQ (Oral transmucosal fentanyl citrate) | DRUG | - |
| ACTIQ® | DRUG | - |
| ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) | DRUG | - |
Inclusion Criteria: Patients are included in the study if all of the following criteria are met: * the patient is at least 18 years old * women must be surgically sterile, 2 years postmenopausal, or if of child-bearing potential, must use a medically accepted method of birth control (ie, barrier me...
ACTIQ is an oral transmucosal fentanyl citrate product studied for the management of breakthrough pain in patients with cancer and other severe pain conditions. Clinical trials have evaluated it in opioid-tolerant children and adolescents with breakthrough pain, as well as in adults with cancer and breakthrough pain.
ACTIQ is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the company associated with the clinical development program for ACTIQ in breakthrough pain.
ACTIQ has been studied in Phase 3 clinical development. The Phase 3 trial NCT00236145 evaluated the efficacy and safety of ACTIQ in patients with cancer and breakthrough pain. Additional Phase 2 studies have also been completed in pediatric and adolescent populations.
ACTIQ has been evaluated in completed clinical trials including NCT00236145, a Phase 3 study in adults with cancer and breakthrough pain, and NCT00236093 and NCT00236041, Phase 2 studies in children and adolescents with breakthrough pain. NCT00236041 enrolled 38 participants.
Yes, ACTIQ is also known as oral transmucosal fentanyl citrate, often abbreviated as OTFC. These names refer to the same product, which is a small molecule formulation of fentanyl citrate delivered through the oral mucosa.