Actiq: profile and news

Barr Announces Agreements With Cephalon, Inc. Regarding Settlement ... Feb 1, 2006
...have entered into agreements to settle its pending patent infringement disputes in the United States related to Cephalon's ACTIQ(R) (oral transmucosal fentanyl ... - International News Service,

Cephalon Reports Outstanding Financial Results for 2005 Feb 14, 2006
In 2005, sales of PROVIGIL(R) (modafinil) Tablets [C-IV] increased 17 percent to $512.8 million; sales of ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II ... - PR Newswire (press release),

Settlements raise shares of Cephalon Feb 3, 2006
...said it settled a patent suit with Barr Laboratories Inc. over generic versions of Cephalon’s Provigil sleep disorder treatment and Actiq pain reliever. ... - Chester Daily Local Online,

Cephalon, Inc. Announces Agreements With Barr Laboratories, Inc. ... Feb 1, 2006
...to settle its pending patent infringement disputes in the United States related to PROVIGIL(R) (modafinil) Tablets [C-IV] and ACTIQ(R) (oral transmucosal ... - Black Enterprise,

Green Light For Growth Feb 3, 2006
...announced late Wednesday it had reached a settlement agreement with generic drugmaker Barr Laboratories (nyse: BRL - news - people ) for Provigil and Actiq. ... - Forbes

Cephalon quarterly earnings fall Feb 14, 2006
...year-ago period. The company's second best-seller, the pain medication Actiq, had sales of $117.8 million, up 36%. The Frazer, Pa ... - MarketWatch

Earnings Outlook Biogen, Genzyme set to report Feb 9, 2006
...reached a deal with several generic drug makers that allows them to market generic versions of Cephalon's top-selling drugs, Provigil and Actiq, when the drugs ... - MarketWatch

Market Highlights Feb 2, 2006
...up $5.50 at $76. The drugmaker settled patent litigation with a generic maker over its Actiq pain reliever and Provigil sleep-disorder treatment. ... - Winston-Salem Journal,

Cephalon Settles Patent Suit With Barr Feb 1, 2006
Laboratories Inc. over generic versions of Cephalon's Actiq pain reliever and Provigil sleep disorder treatment. Cephalon shares ... - MSN Money

Cephalon, Barr Ink Patent Deal Feb 1, 2006
Barr Laboratories (BRL:NYSE - commentary - research - Cramer's Take) that will settle the pending patent infringement disputes related to Provigil and Actiq. ... - TheStreet.com

Update 1: Big Movers in the Stock Market Feb 2, 2006
The drugmaker settled patent litigation with a generic maker over its Actiq pain reliever and Provigil sleep disorder treatment. ... - Forbes

UPDATE 1-Cephalon profit falls on charges, boosts forecast Feb 14, 2006
Sales of Cephalon's Actiq pain drug jumped 36 percent from a year ago to $117.8 million, marking a turnaround from the previous quarter, when sales slipped 2 ... - Reuters

Cephalon's quarterly profits fall Feb 16, 2006
13 percent to $336.4 million from $299 million last year, as sales of Provigil increased 6 percent to $148.3 million and sales of pain reliever Actiq grew 36 ... - Chester Daily Local Online,

Biovail shares climb on hopes of patent resolution Feb 10, 2006
...of Fraser, Pa., has settled patent lawsuits with generic companies over its sleep disorder drug Provigil and cancer pain drug Actiq that will permit authorized ... - Globe and Mail,

Premarket Movers: Coffee and Cake Feb 2, 2006
Barr Laboratories Inc. over generic versions of Cephalon's Actiq pain reliever and Provigil sleep disorder treatment. The companies ... - MSN Money

Wal-Mart Stores Posts Higher January Sales Feb 2, 2006
Cephalon (CEPH ) announces that it reached settlement with Barr Laboratories over a patent infringement related to Provigil Tablets and Actiq. ... - BusinessWeek

(PRN) - Taj Hotels Resorts and Palaces Checks Into Sydney ... [+] Feb 1, 2006
...[+]. (PRN) - Barr Announces Agreements with Cephalon, Inc. Regarding Settlement of ACTIQ(R) and PROVIGIL(R) Patent Litigations ... [+. ... - Bolsamania.com,

Business news in brief Feb 2, 2006
...litigation settlement with generic-drug-maker Barr Laboratories over the Frazer company's biggest-selling product, Provigil, and its cancer-pain drug, Actiq. ... - Philadelphia Inquirer,

Highlights of rising and falling US stocks Feb 2, 2006
Laboratories Inc. (BRL) to settle its pending patent infringement disputes related to Provigil and Actiq. Clorox Co. (CLX) that ... - Investor's Business Daily (subscription)

Highlights of rising and falling US stocks Feb 2, 2006
Laboratories Inc. (BRL) to settle its pending patent infringement disputes related to Provigil and Actiq. Coldwater Creek Inc. (CWTR ... - Investor's Business Daily (subscription)

Cephalon, Inc. Provides Update on Regulatory Status of NUVIGIL(TM) Feb 1, 2006
The company currently markets four proprietary products in the United States: PROVIGIL, GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal ... - PR Newswire (press release),

Cephalon Settles Patent Suit With Barr Feb 1, 2006
Laboratories Inc. over generic versions of Cephalon's Actiq pain reliever and Provigil sleep disorder treatment. Cephalon shares ... - MSN Money

Update 1: Big Movers in the Stock Market Feb 2, 2006
The drugmaker settled patent litigation with a generic maker over its Actiq pain reliever and Provigil sleep disorder treatment. ... - Forbes

Studies Confirm Effectiveness of Fentanyl Lozenges for ' ... Jan 24, 2006
...medicine. The fentanyl lozenge, known as oral transmucosal fentanyl citrate, or OTFC, is also known by the brand name Actiq. The ... - Health Behavior News Service

Premarket Movers: Coffee and Cake Feb 2, 2006
Barr Laboratories Inc. over generic versions of Cephalon's Actiq pain reliever and Provigil sleep disorder treatment. The companies ... - MSN Money

Cephalon, Inc. Provides Update on Regulatory Status of NUVIGIL Feb 2, 2006
The company currently markets four proprietary products in the United States: PROVIGIL, GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal ... - PharmaLive.com (press release),

Business Digest Jan 26, 2006
...techniques. In 1985, he also co-founded Anesta, a drug delivery company with two government-approved products: fentanyl Oralet and Actiq. ... - Salt Lake Tribune,

Horst Witzel, Dr.-Ing., to Retire From Cephalon Board of Directors Jan 31, 2006
...company currently markets four proprietary products in the United States: PROVIGIL(R) (modafinil) [C-IV], GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral ... - PR Newswire (press release),

Horst Witzel, Dr.-Ing., to Retire From Cephalon Board of Directors Jan 31, 2006
...markets four proprietary products in the United States: PROVIGIL® (modafinil) [C-IV], GABITRIL® (tiagabine hydrochloride), ACTIQ® (oral transmucosal ... - Yahoo! News (press release)

Elan meldt financiële resultaten vierde kwartaal en hele jaar ... Jan 31, 2006
Elan Transdermal Technologies, Athena Diagnostics, Elan Diagnostics, a manufacturing business in Italy, the pain portfolio of products, Actiq(TM), the ... - Netherlands Corporate News (persbericht),

MedicareRx Means Stress If You're Poor Jan 19, 2006
Eriquezzo finally got her prescription - a pain medication called Actiq - through the intervention of the Center for Medicare Advocacy in Willimantic, which ... - Hartford Courant,

Cephalon, Inc. Announces Agreement to Acquire Zeneus Holdings ... Dec 5, 2005
...company currently markets four proprietary products in the United States: PROVIGIL(R) (modafinil) [C-IV], GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral ... - PR Newswire UK (press release),

Cephalon, Inc. Announces Agreement with Teva Pharmaceutical ... Dec 9, 2005
The company currently markets four proprietary products in the United States: PROVIGIL, GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal ... - PR Newswire (press release),

Source: Cephalon, Inc.; Zeneus Holdings Limited Dec 5, 2005
...markets four proprietary products in the United States: PROVIGIL® (modafinil) [C-IV], GABITRIL® (tiagabine hydrochloride), ACTIQ® (oral transmucosal ... - Yahoo! News (press release)

Cephalon expected to buy British drugmaker Dec 6, 2005
1 that "2006 will be a transitional year" as the firm's two biggest products, Provigil for sleep disorders and Actiq for severe cancer pain, face generic ... - philly.com,

BDSI Announces Supply Agreement Relating to BEMA(TM) Fentanyl ... Nov 8, 2005
In related BEMA(TM) Fentanyl news, BDSI recently reported positive results in a pharmacokinetic study comparing BEMA(TM) Fentanyl and Actiq(R), a lozenge ... - Business Wire (press release),

LAB International revenues increases by 70% in third quarter Nov 8, 2005
...of Fentanyl TAIFUN(R) clinical trials including the successful completion of a favorable Phase I comparing the commercially available Actiq(R) lozenge. ... - PR Newswire (press release),

Morrisville biotech picks Florida firm to supply drug Nov 9, 2005
The Morrisville company also released results of a 12-patient study that showed its drug was absorbed by the body more efficiently than Actiq, a fentanyl ... - Raleigh Triangle Business Journal,

LAB International Revenues Increases by 70% in Third Quarter Nov 8, 2005
On a consolidated basis,. clinical trial for its novel asthma product, LAB CGRP. Positive. commercially available Actiq(R) lozenge. The preparation of a Phase. ... - PharmaLive.com (press release),

Cephalon Says Sugar-Free Actiq Approved Sep 12, 2005
FRAZER, Pa. (AP) - Cephalon Inc. said Monday regulators approved a sugar-free version of its Actiq painkiller for cancer patients. ... - MSN Money

Cephalon gets OK for sugar-free Actiq Sep 12, 2005
...said Monday it has received an approval letter from the Food and Drug Administration to sell a new sugar-free formulation of its cancer pain drug Actiq. ... - Philadelphia Business Journal,

FDA Approvals: Nevanac, Sugar-Free Actiq, Quinine Sulfate Sep 15, 2005
9, the FDA approved a sugar-free formulation of oral transmucosal fentanyl citrate (Actiq, made by Cephalon, Inc.) for the management of breakthrough pain in ... - Medscape (subscription)

Cephalon Says Sugar-Free Actiq Approved Sep 12, 2005
Cephalon Inc. said Monday regulators approved a sugar-free version of its Actiq painkiller for cancer patients. The Food and Drug ... - Forbes

Cephalon Receives FDA Approval to Market Sugar-Free Formulation of ... Sep 12, 2005
...announced today that it has received an approval letter from the US Food and Drug Administration (FDA) to market a new sugar-free formulation of ACTIQ(R) (oral ... - PR Newswire (press release),

Lollipop painkiller goes sugar free Sep 13, 2005
...seeking to circumnavigate this problem is Cephalon, which sells a lozenge-on-a-stick formulation of an opioid analgesic, called Actiq (fentanyl), intended for ... - in-PharmaTechnologist,

Prescription for Success Sep 21, 2005
The company already markets an oral form of the drug called Actiq, which brought in about $92 million in revenue in the June quarter. ... - Smartmoney.com (subscription)

Success, challenges at Cephalon Sep 11, 2005
Cephalon’s fortunes for the time being, however, are tied to the sale of its three main products, Provigil, Actiq and Gabitril. ... - Chester Daily Local Online,

Business news in brief Sep 13, 2005
...said it has received Food and Drug Administration approval to sell a new sugar-free formulation of Actiq, a berry-flavored cancer pain treatment on a stick. ... - Philadelphia Inquirer,

Eye On Stocks For Tuesday, Sept. 13 Sep 12, 2005
Cephalon (nasdaq: CEPH - news - people ) said it received an approval letter from federal health regulators for a new formulation of Actiq, a cancer pain ... - Forbes

FDA Extends PDUFA Date for VIVITREX(R) to December 30, 2005 ... Sep 20, 2005
...company currently markets four proprietary products in the United States: PROVIGIL(R) (modafinil) (C-IV), GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral ... - Genetic Engineering News,

(PRN) - The Plastic Surgery Group: Facelift Techniques Today Offer ... Sep 12, 2005
Hurricane Relief ... [+. PRN) - Cephalon Receives FDA Approval to Market Sugar-Free Formulation of ACTIQ(R) ... [. PRN) - 15th ... - Bolsamania.com,

Cephalon Making Progress With New Products Sep 6, 2005
..."We think approval of OVF is necessary for Cephalon to offset generic competition to actiq that we see as likely by 2007," S&P Equity Research said. ... - Forbes

Cephalon seeking approval for new cancer pain drug Sep 6, 2005
...medication. Cephalon spokesman Robert W. Grupp said the drug would be a different version of its Actiq lozenge for cancer patients. Grupp ... - Philadelphia Business Journal,

Cephalon, Inc. Announces Agreement With McNeil Consumer & ... Sep 1, 2005
The company currently markets four proprietary products in the United States: PROVIGIL, GABITRIL(R) (tiagabine hydrochloride) ACTIQ(R) (oral transmucosal ... - PR Newswire (press release),

Cephalon Receives Approval to Market Modafinil for Shift Work ... Aug 30, 2005
The company currently markets four proprietary products in the United States: PROVIGIL®, GABITRIL® (tiagabine hydrochloride), ACTIQ® (oral transmucosal ... - Yahoo News (press release)

Cephalon Board Member Gail Wilensky Appointed to World Health ... Aug 25, 2005
...markets four proprietary products in the United States: PROVIGIL® (modafinil) [C-IV], GABITRIL® (tiagabine hydrochloride), ACTIQ® (oral transmucosal ... - Yahoo News (press release)

Cephalon Board Member Gail Wilensky Appointed to World Health ... Aug 25, 2005
...company currently markets four proprietary products in the United States: PROVIGIL(R) (modafinil) [C-IV], GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral ... - PR Newswire (press release),

Other information

Indication
For the treatment of cancer patients with severe pain that breaks through their regular narcotic therapy.

Pharmacology
Fentanyl is an opioid analgesic. Fentanyl interacts predominately with the opioid mu-receptor. These mu-binding sites are discretely distributed in the human brain, spinal cord, and other tissues. In clinical settings, Fentanyl exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation. Fentanyl may increase the patient's tolerance for pain and decrease the perception of suffering, although the presence of the pain itself may still be recognized. In addition to analgesia, alterations in mood, euphoria and dysphoria, and drowsiness commonly occur. Fentanyl depresses the respiratory centers, depresses the cough reflex, and constricts the pupils.

Mechanism Of Action
Opiate receptors are coupled with G-protein receptors and function as both positive and negative regulators of synaptic transmission via G-proteins that activate effector proteins. Binding of the opiate stimulates the exchange of GTP for GDP on the G-protein complex. As the effector system is adenylate cyclase and cAMP located at the inner surface of the plasma membrane, opioids decrease intracellular cAMP by inhibiting adenylate cyclase. Subsequently, the release of nociceptive neurotransmitters such as substance P, GABA, dopamine, acetylcholine and noradrenaline is inhibited. Opioids also inhibit the release of vasopressin, somatostatin, insulin and glucagon. Fentanyl's analgesic activity is, most likely, due to its conversion to morphine. Opioids close N-type voltage-operated calcium channels (OP2-receptor agonist) and open calcium-dependent inwardly rectifying potassium channels (OP3 and OP1 receptor agonist). This results in hyperpolarization and reduced neuronal excitability.

Drug Category
Anesthetics; Narcotics; Adjuvants; Analgesics; Opiate Agonists; ATC:N01AH01; ATC:N02AB03

Brand Names/Synonyms
Actiq; CHEMBANK1683; Dea No. 9801; Duragesic; Duragesic-100; Durogesic; F5886; Fentanest; Fentanil; Fentanil [Dcit]; Fentanila; Fentanila [Inn-Spanish]; Fentanyl; Fentanyl Citrate; Fentanyl Citrate Preservative Free; Fentanylum; Fentanylum [Inn-Latin]; HSDB 3329; Pentanyl; Phentanyl; R 4263; Sentonil; Sublimaze; Sublimaze Preservative Free

Dosage Forms
DISC (SUSTAINED-RELEASE); LIQUID; SOLUTION

Absorption
Not Available

Interactions
Interactions for Fentanyl:

Agents Affecting Cytochrome P450 3A4 Isoenzyme System

Fentanyl is metabolized mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when DURAGESIC® is given concurrently with agents that affect CYP3A4 activity. Coadminstration with agents that induce 3A4 activity may reduce the efficacy of DURAGESIC®. The concomitant use of transdermal fentanyl with ritonavir or other potent 3A4 inhibitors such as ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazadone may result in an increase in fentanyl plasma concentrations. The concomitant use of other CYP3A4 inhibitors such as diltiazem and erythromycin with transdermal fentanyl may also result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause serious respiratory depression. In this situation, special patient care and observation are appropriate.

Central Nervous System Depressants

The concomitant use of DURAGESIC® (fentanyl transdermal system) with other central nervous system depressants, including but not limited to other opioids, sedatives, hypnotics, tranquilizers (e.g., benzodiazepines), general anesthetics, phenothiazines, skeletal muscle relaxants, and alcohol, may cause respiratory depression, hypotension, and profound sedation, or potentially result in coma or death. When such combined therapy is contemplated, the dose of one or both agents should be significantly reduced.

MAO Inhibitors

DURAGESIC® is not recommended for use in patients who have received MAOI within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.

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Chemical IUPAC Name
N-(1-phenethyl-4-piperidyl)-N-phenyl-propanamide

Chemical Formula
C22H28N2O

Half Life
7 (range 3-12) hours

Drug Type
Approved Drug

# Accession No
APRD00347

CAS Registry Number
437-38-7