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Actiq

Actiq, by Cephalon, is a recently-developed Categrory 2 solid formulation of fentanyl citrate on a stick that dissolves slowly in the mouth for transmucosal absorption. more...

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Actiq is intended for opiate-tolerant individuals and is effective in treating breakthrough cancer pain. It is also useful for breakthrough pain for those suffering bone injuries, migraines, severe back pain, neuropathy, arthritis, and some other examples of chronic, non-malignant pain. The unit is a berry-flavored lozenge on a stick which is swabbed on the mucosal surfaces inside the mouth - under and on the tongue and gums - to release the fentanyl quickly into the system. It is most effective when the lozenge is consumed in exactly 15 minutes, as the balance of the drug absorbed through the cheeks and the amount swallowed is maintained. The drug is far less potent if consumed orally compared to sublingually. Actiq is available in 6 dosages, from 200 μg to 1,600 μg (There are no 1,000 μg or 1,400 μg doses)in 200 μg increments.

A sugar-free version is in development. Since the current version is held between the cheek and gum and contains sugar, it could lead to eventual tooth decay. Diabetics also need to take its sugar content into account. Side effects include the normal side effects found with this class of narcotic analgesic plus constipation and dry mouth.

Fentanyl is frequently given intrathecally as part of spinal anesthesia or epidurally for epidural anesthesia and analgesia.

Read more at Wikipedia.org


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FDA says Cephalon's Actiq product is 'approvable'
From Deseret News (Salt Lake City), 3/26/05

FRAZER, Pa. (Dow Jones/AP) -- Cephalon Inc. Friday said the U.S. Food and Drug Administration considers the new, sugar-free formulation of pain drug Actiq "approvable."

Cephalon makes Actiq at its operations in Salt Lake City.

The biopharmaceutical company, which is based in West Chester, Pa., expects full approval of sugar-free Actiq in the third quarter. It said the sugar-free formulation will be marketed for the same indication, cancer pain, and use the same name. Studies of Actiq demonstrated that the sugar-free versions works like the currently marketed formulation, according to the company.

Cephalon noted the announcement marks the first of five FDA approvals it will be pursuing over 15 months.

Copyright C 2005 Deseret News Publishing Co.
Provided by ProQuest Information and Learning Company. All rights Reserved.

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