Recent Updates
Recently added Catalysts

ACTIQ

Phase 3

Breakthrough Pain | Small molecule | Pain |Teva Pharmaceutical Industries Limited|Last Updated: May 9, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

ACTIQ · 3 trials · 5 indications

Phase 3 1Phase 2 2
NCT00236145Evaluate the Efficacy and Safety of ACTIQ in Patients With Cancer and Breakthrough PainBreakthrough Pain
COMPLETED- Analytics
PHASE3COMPLETED
Evaluate the Efficacy and Safety of ACTIQ in Patients With Cancer and Breakthrough Pain
Breakthrough Pain
NCT00236145-
Unlock trial analytics

Study Endpoints

Primary Endpoints

to determine if ACTIQ treatment will reduce the number of inadequately managed episodes of breakthrough pain
The objective of the study is to monitor the safety (adverse event data) of longer-term use of ACTIQ treatment in children with pain and BTP who are receiving ATC opioid therapy.
Pain intensity differences as measured by the FPS-R

Secondary Endpoints

Time to adequate analgesia
Duration of analgesia
Percentage of BTP episodes requiring rescue medication, or for which oversedation occurs
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
ACTIQ (Oral transmucosal fentanyl citrate)DRUG -
ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])DRUG -
ACTIQ®DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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...

Countries:United StatesCanadaPuerto Rico
Unlock Eligibility Criteria

Frequently asked questions about ACTIQ

What is ACTIQ used for?

ACTIQ is used for the management of breakthrough pain in patients with cancer who are opioid-tolerant. It is also being studied for pain associated with sickle cell anemia and severe burns. ACTIQ is a small molecule developed by Teva Pharmaceutical Industries Limited.

What does ACTIQ target?

ACTIQ contains fentanyl, an opioid agonist that targets mu-opioid receptors in the central nervous system. By binding to these receptors, it modulates pain signaling pathways to provide rapid relief of breakthrough pain episodes in opioid-tolerant patients.

Who makes ACTIQ?

ACTIQ is developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker TEVA. Teva is responsible for the clinical development and commercialization of the drug.

What phase is ACTIQ in?

ACTIQ is in Phase 3 clinical development for the treatment of breakthrough pain in cancer patients. It has completed Phase 2 and Phase 3 trials, including studies in children and adolescents with breakthrough pain related to cancer and other conditions.

What clinical trials is ACTIQ in?

ACTIQ has been studied in clinical trials including NCT00236041, a Phase 2 study in opioid-tolerant children and adolescents with breakthrough pain; NCT00236093, an extension study in patients with pain from cancer, sickle cell anemia, or severe burns; and NCT00236145, a Phase 3 study in adults with cancer and breakthrough pain.

Is ACTIQ the same as fentanyl?

ACTIQ is a brand name for a formulation of fentanyl, an opioid analgesic. It is designed for transmucosal administration to provide rapid onset of action for breakthrough pain. While it contains the same active ingredient as other fentanyl products, ACTIQ is a specific dosage form.