From: (Samson)
Newsgroups: alt.drugs.hard
Subject: Actiq: Fentanyl lollipop coming in 1999
Date: 6 Nov 1998 18:57:51 GMT

Thursday November 5 6:48 PM ET

FDA approves narcotic lozenge for cancer pain

   NEW YORK, Nov 05 (Reuters Health) -- The US Food and Drug
   Administration (FDA) approved a narcotic-containing
   ''lozenge-on-a-stick'' on Thursday that cancer patients can suck on
   when their regular doses of pain-killing drugs prove ineffective. The
   product, called Actiq, contains fentanyl citrate, a narcotic stronger
   than morphine.

   ``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,'' according to a statement issued by the federal agency.

   The FDA refused to approve the drug for marketing at the end of last
   year because of concerns that children might accidentally ingest the
   drug. The drug could be fatal to children or to adults who are not
   already taking opioid narcotics.

   The company addressed such issues with the FDA, according to Thomas B.
   King, president and CEO of Anesta, the Salt Lake City, Utah-based
   company that manufactures Actiq.

   When the product is introduced to the market in March of 1999,
   distribution will be restricted under special regulations, and a risk
   management program will be implemented to educate patients and
   physicians on the safe use of the drug. In addition, King said that
   the program would also educate pharmacists, who counsel patients on
   how to properly use, store, and dispose of the drug.

   The company said that the lozenge is indicated only for the management
   of breakthrough cancer pain in patients who have cancer and are
   already receiving and tolerant of opioid therapy. About half of the
   800,000 cancer patients in the US experience breakthrough pain, or
   pain that is not controlled by their regular medication.

   Actiq is not approved for use in treating acute or postoperative pain,
   or in patients who have not become tolerant to other opioid
   medications, according to a statement issued by Anesta.

   ``We believe that Actiq will provide a valuable new tool for
   clinicians to help cancer patients control their breakthrough cancer
   pain.'' King said.

   The most common side effects of the drug are sleepiness, dizziness,
   nausea and constipation.
     _________________________________________________________________

    Copyright © 1998 Reuters Limited.

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