Actiq (Fentanyl Citrate Oral Transmucosal) - Summary

ACTIQ SUMMARY

Actiq (oral transmucosal fentanyl citrate) is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. Actiq is formulated as a white to off-white solid drug matrix on a handle that is radiopaque and is fracture resistant (ABS plastic) under normal conditions when used as directed.

Actiq is indicated only for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg morphine/day, 50 mcg transdermal fentanyl/hour, or an equianalgesic dose of another opioid for a week or longer.

Because life-threatening hypoventilation could occur at any dose in patients not taking chronic opiates, Actiq is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients.

Actiq is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

Actiq should be individually titrated to a dose that provides adequate analgesia and minimizes side effects. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient's mouth immediately, disposed of properly, and subsequent doses should be decreased (see DOSAGE AND ADMINISTRATION).

Patients and their caregivers must be instructed that Actiq contains a medicine in an amount that can be fatal to a child. Patients and their caregivers must be instructed to keep all units out of the reach of children and to discard opened units properly in a secured container.

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ACTIQ NEWS HIGHLIGHTS

Media Articles Related to Actiq (Fentanyl Oral Transmucosal)

New Treatment For Receding Gums: No Pain, Lots Of Gain
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2009.07.02]
Tufts dental researchers conducted a three-year follow-up study that examined the stability of a treatment option for receding gums and found that complete root coverage the goal of the surgery had been maintained. This specific tissue regeneration application, developed at Tufts, reduces the considerable pain and recovery time of gum grafting surgery. The case study of six patients is published in the July 2009 issue of the Journal of Periodontology.

Increasing Age Of Mothers In Spain Leads To Rise In Mortality Rates
Source: Seniors / Aging News From Medical News Today [2009.07.02]
A new study examining the evolution of maternal mortality rates in Spain since 1996 shows a 17% increase in deaths. This trend is linked to the widespread increase in maternal age. The highest death rates are among foreign women and those who live in the province of Malaga. Medicine has taken giant strides during the 20th Century. However, European studies show a clear and constant increase in maternal mortality rates over recent years.

Health Tip: What's Causing My Neck Pain?
Source: MedicineNet Arthritis Specialty [2009.07.02]
Title: Health Tip: What's Causing My Neck Pain?
Category: Health News
Created: 7/2/2009 7:00:00 AM
Last Editorial Review: 7/2/2009

Laughter - The Best Medicine? Spain Hosts The Most Renowned International Symposium On Sense Of Humor And Its Applications
Source: Conferences News From Medical News Today [2009.07.01]
Spain hosts this week, for the first time in history, this event, the most renowned international symposium on humour and laughter, where scientists and experts from four continents will discuss the latest advances and research of this field of study.

Lower Empathic Responses To Outsiders' Pain Shown By Imaging Study
Source: Neurology / Neuroscience News From Medical News Today [2009.07.01]
An observer feels more empathy for someone in pain when that person is in the same social group, according to new research in the July 1 issue of The Journal of Neuroscience. The study shows that perceiving others in pain activates a part of the brain associated with empathy and emotion more if the observer and the observed are the same race. The findings may show that unconscious prejudices against outside groups exist at a basic level.

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Published Studies Related to Actiq (Fentanyl Oral Transmucosal)

A randomized clinical trial of oral transmucosal fentanyl citrate versus intravenous morphine sulfate for initial control of pain in children with extremity injuries. [2007.08]
BACKGROUND: Extremity injury is a common condition that requires pain management in an emergency department. In pediatric patients, the most frequently used method of pain control is intravenous (IV) morphine sulfate. Oral transmucosal fentanyl citrate (OTFC) is a potential alternative to morphine, which may obviate the need to place an IV before addressing pain. OBJECTIVE: To compare OTFC with IV morphine for sedation and analgesia during initial evaluation of children with deformity of an extremity and suspected fracture... CONCLUSIONS: The use of OTFC can provide improved pain control when compared with IV morphine. The pain reduction starts 30 minutes after initiation of medication, and the effect is seen as far as 75 minutes after the initiation of analgesic medication. The study size was too small to make any statements concerning adverse effects; thus, further studies with larger sample sizes are needed to determine the use of OTFC.

Transmucosal fentanyl vs intravenous morphine in doses proportional to basal opioid regimen for episodic-breakthrough pain. [2007.06.18]
The use of supplemental doses of opioids is commonly suggested to manage breakthrough pain. A comparative study of intravenous morphine (IV-MO) and oral transmucosal fentanyl citrate (OTFC) given in doses proportional to the basal opioid regimen was performed in 25 cancer patients receiving stable opioid doses... Future comparative studies with appropriate design should compare titration methods and proportional methods of OTFC dosing.

Oral transmucosal fentanyl citrate versus placebo for painful dressing changes: a crossover trial. [2007.03]
CONCLUSION: Compared with placebo, OTFC improved analgesia during painful dressing changes without an increase in side-effects.

Relative bioavailability of the fentanyl effervescent buccal tablet (FEBT) 1,080 pg versus oral transmucosal fentanyl citrate 1,600 pg and dose proportionality of FEBT 270 to 1,300 microg: a single-dose, randomized, open-label, three-period study in healthy adult volunteers. [2006.05]
BACKGROUND: The fentanyl effervescent buccal tablet (FEBT) was designed to enhance the rate and extent of absorption of fentanyl through the buccal mucosa. FEBT is being investigated for the management of breakthrough pain. OBJECTIVES: The primary objective of this study was to compare the relative bioavailability of FEBT 1,080 microg with that of oral transmucosal fentanyl citrate (OTFC) 1,600 microg, and the secondary objective was to assess the dose proportionality of FEBT 270 to 1,300 microg in healthy adult volunteers... CONCLUSIONS: In this pharmacokinetic study in healthy volunteers, total systemic exposure increased in a dose-proportional manner up to FEBT 1,300 microg, whereas doses above 810 microg showed a less-than-dose-proportional increase in C(max). The results suggest that fentanyl enters the systemic circulation to a significantly greater extent (C(max) and AUC(0-Tmax')) and significantly more rapidly (T(max)) with FEBT compared with OTFC.

The pharmacokinetics of the intravenous formulation of fentanyl citrate administered orally in children undergoing general anesthesia. [2004.11]
The bioavailability of oral transmucosal fentanyl citrate (OTFC) in children is similar to that of fentanyl solution administered orally to adults. We hypothesized that administering an oral fentanyl solution to children would result in similar fentanyl plasma concentrations and pharmacokinetic variables as administering comparable doses of OTFC.This suggests that this method of administration be used with caution until further data are available.

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Clinical Trials Related to Actiq (Fentanyl Oral Transmucosal)

Staccato® Fentanyl Pharmacokinetics in Healthy Volunteers [Completed]
The Phase I clinical trial in approximately 50 healthy volunteers will be conducted at a single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a single dose of Staccato Fentanyl and an equivalent dose of intravenous (IV) fentanyl. Stage 2 is a randomized, doubleblind, placebo-controlled dose escalation of Staccato Fentanyl, evaluating multiple doses of fentanyl. The three primary aims of the Phase I clinical trial are to evaluate the pharmacokinetics (PK) and absolute bioavailability for Fentanyl, compare the Staccato Fentanyl PK profile to the IV fentanyl PK profile, and examine the tolerability and safety of Staccato Fentanyl in a non-opioid-tolerant, healthy volunteer population.

Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl [Completed]
CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after epidural injection. The objective of this investigation was to compare the analgesic effect of epidural and intravenous Fentanyl for lower limb orthopedic surgeries.

DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital São Paulo.

METHODS: 29 patients were divided into two groups. During the postoperative period, in the presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n = 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL epidural 0. 25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity was evaluated by numerical scale and plasma concentrations of Fentanyl were measured simultaneously.

Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr [Terminated]
The objective of this study was to investigate the effect of clinical procedures on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation.

Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System [Completed]
The objective of this study was to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation. The acute irritation of each type of overlay worn with each fentanyl treatment was also assessed after patch removal.

Evaluate the Efficacy and Safety of ACTIQ in Patients With Cancer and Breakthrough Pain [Completed]
The primary objective of the study is to determine whether a test titration regimen of ACTIQ treatment will reduce the number of inadequately managed episodes of breakthrough pain for an individual patient by attaining a successful dose of ACTIQ treatment more quickly. The successful ACTIQ dose provides a satisfactory combination of efficacy and tolerability after a single administration, as assessed by the patient.

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