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Home > Media > On The Record > Archive > Set the Record Straight About ACTIQ®

Setting the Record Straight about ACTIQ^®

What you may not know about ACTIQ

Cephalon has a rigorous monitoring and surveillance program to ensure safe use of ACTIQ. Here are the facts since the product was launched in April 1999 through October 2006:

• ACTIQ is approved for patients with cancer who experience breakthrough pain and who are already taking opioid medication for their underlying persistent pain. Many of these patients are terminally ill and desperately need the pain relief that ACTIQ can provide.
• Since the product was launched, 1.86 million ACTIQ prescriptions have been written. (Click here for additional facts about ACTIQ)
• Tens of thousands of patients have safely experienced relief with ACTIQ since its introduction. For known cases of serious adverse events , the estimated reporting rate is 0.2 percent of patients who used ACTIQ in one year of treatment.¹
• Under a Risk Management Program approved by the U.S. Food and Drug Administration for ACTIQ, the company submits comprehensive quarterly reports to the agency on safety-related issues.

Compared to other opioid medications on the U.S. market, ACTIQ is not widely misused or abused. There is no evidence that ACTIQ is widely abused or used as a recreational drug. To the contrary, reports of abuse and diversion2 of ACTIQ remain low when compared with many other opioid medications.

• During the past several years, ACTIQ prescriptions have ranged from about 0.2 – 0.3 percent of all opioid prescriptions nationwide.³
• Recent data from the Drug Abuse Warning Network (DAWN) show that ACTIQ (and other pharmaceutical medications whose active ingredient is fentanyl) represents a small fraction of the opioid drug-related emergency room visits. (click for chart) All fentanyl-related visits in the DAWN database represent approximately 5 percent of the nearly 158,281 cases related to non-medical use of pharmaceutical opioids.⁴
• The reporting rate of suspected diversion of ACTIQ is approximately 0.00001 percent of the number of units dispensed. Despite a growth in sales, there has not been a corresponding increase in the rate of diversion based upon reports received by the company through October 2006.
• Illegal use of any of our medications is of grave concern, and Cephalon is committed to minimizing the inappropriate use of ACTIQ. We market the medication under a detailed Risk Management Program approved by the Food and Drug Administration. While no plan can eliminate all instances of inappropriate use, our track record is strong.

Physicians must have transparent access to accurate, scientific information to make informed treatment decisions for their patients. We give physicians appropriate information to help them effectively treat their patients’ medical needs.

• Our sales force has always been trained to provide information about ACTIQ for its approved use to physicians with expertise to prescribe opioids for the appropriate patient population.
• Some physicians may prescribe our product for uses that are not approved by the Food and Drug Administration in order to treat unmet needs of patients whose conditions are not adequately served by approved medications. Such prescribing is integral to the practice of medicine and is an absolutely acceptable medical practice when there is supporting scientific data and when the physician believes the benefits to the patient outweigh the risks.
• We are committed to providing up-to-date scientific and medical information to physicians that ensures patients’ health and safety. Cephalon does not market or promote drugs for uses outside of the approved indication, and we maintain a rigorous internal compliance program designed to help ensure that our promotional practices meet the letter and spirit of all applicable laws and regulations.

¹ A 'serious adverse event' includes: a life-threatening condition; hospitalization; persistent, significant disability; death; and/or other important medical side effects.
² Diversion is illegal activity involving the transfer of a medication to anyone who does not have a prescription. This includes sales of drugs on the street, theft from pharmacies and other locations, but also sharing a prescription with someone else. Despite tight controls on production and distribution, some diversion occurs primarily through theft and fraud.
³ Source: Wolters Kluwer Source Prescriber.
⁴ DAWN (Drug Abuse Warning Network) 2004 (pages 41-42): Released April 2006. Fentanyl medications include patch, intravenous, transmucosal, and buccal formulations.

For full prescribing information on ACTIQ^®, including boxed warning, please click here to visit the ACTIQ^® website.