FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
T98-78                            Print Media:         301-827-6242
November 5, 1998                    
                                  Consumer Inquiries:  888-463-6332  
                                                          (INFO-FDA)

FDA APPROVES ACTIQ FOR MARKETING

DRUG OFFERS CANCER PATIENTS RELIEF FROM BREAKTHROUGH CANCER PAIN

FDA approved for marketing Actiq, a new product developed specifically for cancer patients with severe pain that breaks through their regular narcotic therapy. Actiq is a dosage form of fentanyl citrate, an opioid narcotic more powerful than morphine. The medicine is in the form of a flavored sugar lozenge that dissolves in the mouth while held by an attached handle.

While Actiq is an effective treatment for breakthrough cancer pain, it is not without risk. Because Actiq may be fatal to children (as well as to adults not already taking opioid narcotics), FDA approved Actiq under special regulations that restrict distribution as defined in a comprehensive risk management plan.

Many patients with cancer experience persistent pain which is treated with oral narcotics. These patients, however, often also experience breakthrough pain. Breakthrough cancer pain is acute, with sudden onset, and can occur spontaneously or as a result of activity.

Actiq is designed to be dissolved slowly in the mouth until the medicine is consumed. The unit is consumed in approximately 15 minutes, with pain relief beginning in some cases while Actiq is still being consumed. Patients may obtain further relief for up to several hours after taking Actiq.

This approval follows the September 17, 1997 recommendation of the Drug Abuse Drugs Advisory Committee to ensure that a comprehensive risk management plan be in place when this product was approved. These measures are now in place.

Because of the uniqueness of the dosage form and because fentanyl is a potent schedule II narcotic, FDA advisory committee members and the Agency were extremely concerned that this product be packaged and marketed to minimize the opportunity for diversion, abuse, or access by children.

During clinical trials, the most common reported side effects were sleepiness, dizziness, nausea, and constipation. Anesta Corporation of Salt Lake city, Utah will market Actiq with partner Abbott Laboratories.

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