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  • RANDYCHUB RANDYCHUB Aug 30, 2005 9:00 AM Flag

    Actig - Percapop (lollipop) - This drug

    hit 120 million in sales last quarter and that figure does not include street sales.

    R



    HARRISBURG, Pennsylvania -- A narcotic painkiller that looks like a lollipop -- designed to speed relief to cancer patients -- is starting to show up in illegal sales with the nickname "perc-a-pop."
    The drug's ease of use and sweet taste have law enforcement officials worried about the potential for abuse. Actiq, a berry-flavored lozenge on a stick, contains the synthetic opioid fentanyl.

    "We're starting to see it emerge as a drug that is, as we call it, 'diverted,' which is a legally prescribed drug being used illegally," said Kevin Harley, spokesman for state Attorney General Jerry Pappert.

    "It's a drug that is easily administered or taken by somebody who might be afraid to either take a pill, snort or inject a needle in their arm."

    The attractive taste -- described by the manufacturer as a "mild berry flavor" -- makes abuse more likely, he added. Harley said each Actiq lozenge retails for $9.10. The street value of a perc-a-pop is $20.

    "We started seeing them in Philly, and that's where we understand the nickname came from," he said.

    Manufactured by Cephalon Inc., Actiq's active ingredient is absorbed by rubbing the lozenge against the inside of the cheek.

    It is approved by the Food and Drug Administration to combat "breakthrough pain," flare-ups suffered by cancer patients who are already taking narcotics in more conventional liquid or pill form to cope with chronic pain.

    "Like any opioid, there is a potential for misuse," said company spokeswoman Stacey Backhardt. She said the company believes, however, "there has not been a substantial diversion of this product in the state or elsewhere."

    Fentanyl was first introduced as an intravenous anesthetic called Sublimaze in the 1960s. Besides being taken orally, it is also dispensed as a transdermal patch under the trade name Duragesic.

    Hospitals in the lower 48 states reported 576 incidents of non-medical use of fentanyl products in 2000; the number rose to 1,506 by 2002, said Leah R. Young, spokeswoman for the federal Substance Abuse and Mental Health Services Administration.

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    • An SPA, once endorsed by the FDA, becomes a binding contract which assures FDA approval if the safety and efficacy endpoints of the trial(s) are met. As such, the SPA process is akin to a miniature, compressed version of the FDA�s NDA/BLA approval process.

      To fully understand SPA�s, please read this:

      http://www.fda.gov/cder/guidance/3764fnl.htm

      Thanks to Dew for this information which is also available on the ihub.

      Randy

    • The 120 million should definitely include the
      diverted street sales. The comapny cannot maintain a separate sales organization for the legitimate vs. street sales.


      The delex drug should look less intresting street drug because of the long duration of the effect.

      Nonetheless approval will not be easy, as it is not easy for any opioid drug.
      Partnering will not be very easy either, as
      most drug companies will not touch an opioid product. So potential competitors and potential partners are the same. It might not be that hard to do it alone on the other hand.
      I think the start of this trial triggered payment of stocks to the previous owners.
      I do not know when they will have the right to sell it.

 

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