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  • labstat_phd labstat_phd Oct 25, 2013 7:22 PM Flag

    U.S. Recommends Tighter Control on Hydrocodone Pain Pills (google it)

    "Vicodin and other hydrocodone-based painkillers, the most popular pharmacy drugs in the U.S., would be placed under stricter prescribing limits to curb abuse, in a policy reversal by the Food and Drug Administration.
    The FDA agreed to recommend by early December reclassifying the pills as a Schedule II substance, Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said in a statement. Hydrocodone combinations, are currently Schedule III, the third-highest level on a five-stage scale that takes into account the potential for addiction.
    About 131 million hydrocodone products were dispensed in 2011, more than double the number for oxycodone pills, which have greater restrictions, according to an FDA report released in January. The Drug Enforcement Administration for about a decade has been asking the FDA to recommend reclassifying the products to Schedule II from III, including in 2004, a request the FDA denied in 2008. The DEA resubmitted its request in 2009.
    “While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse.
    The FDA said it anticipates the National Institute on Drug Abuse will side with its recommendation, as will the DEA.

    “Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs,” U.S. Senator Chuck Schumer, a New York Democrat, said in a statement. “I’m very pleased that the FDA has heeded my call and will tighten up control of one of the most highly prescribed -- and abused -- drugs on the market.”
    Schumer called on the FDA in January to tighten controls on the drugs to “combat an unprecedented spike in prescription drug abuse in New York state and the country,” according to his statement.

    Z160 is NON Opioid/ NON Addictive

    Sentiment: Strong Buy

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    • I agree with your conclusions. My experiences as a holder of JAZZ pharma leads me to believe that Z160 will be the off label replacement of choice by a good percentage of the Vicodin users once they can no longer get their favorite pain killer of choice. Z160 if approved is already being targeted to have a potential market of 1 -4 Billion per year but if what I believe to be likely actually occurs? try 6-8 Billion - and that's just for this one NDA. There are about 7 others in the pipeline. Until then it's follow the very short time frame trend for wild swings or put the whole thing on ignore for a month while the top line data from Z160 2a is analyzed. Once simple piece of advice if you're a long; buy the dips. It's less likely you'll be shaken out if you take this approach. Remeber, even a 1 Billion Dollar success story for Z160 translates into a 60.00 stock. Im sure I don't have to remind you that there are only 22 million shares outstanding.

      Sentiment: Strong Buy

    • But tighter controls on Vicodin to reduce access to the addicted and those not really needing it does not increase the market for non opiod pain killers. It just reduces the market for Vicodin etc.. . Z160 is not a replacement for the lost market share as it is not addictive and those users are not looking so much for pain relief. Jmho
      So how does that help Zalicus?