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Titan Pharmaceuticals Inc. Message Board

  • yuri_g1 yuri_g1 Feb 22, 2013 6:08 AM Flag

    Reckitt Hires Key Bureaucrat Amid Suboxone Tumult

    This is a great news for RB. They found o Top Gun to kill generics! This is an axcellent news for Titan!

    Amid a raging controversy over its strategy for promoting the Suboxone treatment for opioid dependence, Reckitt Benckiser has hired a career government bureaucrat who can help the company better navigate the curious world of opioid treatment programs and federal regulations. In a little-noticed move, Nicholas Reuter joined Reckitt earlier this month as manager of treatment health policy and government affairs, a Reckitt spokesman confirms.

    Reuter, who spent 37 years with the federal government, was most recently a senior public health analyst with the Substance Abuse & Mental Health Service Administration, or SAMHSA. And his crowning accomplishment was shepherding the rulemaking process for getting buprenorphine – which is sold as Suboxone and other names – into opioid treatment programs, according to Alison Knopf, editor of Alcoholism & Drug Abuse Weekly, which first reported the hiring.

    The rule, which took effect last month, allows opioid treatment programs to dispense the drug without various take-home restrictions. “He is a godsend to them and a huge loss to the federal government, and to anybody who wants to come up with another, cheaper alternative” to Suboxone, Knopf says. “He knows the regulations by heart, for OTPs and for… laws allowing physicians to get waivers to treat opioid addicts with an opioid. He is an encylopedia.”

    His arrival may not help Reckitt with all of its myriad issues surrounding Suboxone, but the timing is certainly fortuitous. Apart from combating problems with diversion and abuse, the company is working furiously to promote a newer sublingual, or film version, of its drug, while preventing generic drugmakers from selling low-cost versions of its older tablet, which is being withdrawn from the US market.

    Toward this end, Reckitt has argued that children could be accidentally harmed by easy access to tablets that are marketed in bottles as a justification for withdrawing its tablet. Reckitt recently cited specially commissioned data showing higher rates of “accidental unsupervised pediatric exposure” with Suboxone tablets than with Suboxone Film, which can only be accessed by tearing open individual blister packaging but was never used for its tablets.
    At the same time, Reckitt filed a Citizen’s Petition with the FDA, asking the agency not to approve any generic versions of Suboxone tablets unless manufacturers implement “national public health safeguards” to reduce pediatric risk (back story). The FDA asked Reckitt to work with generic drugmakers to develop a Risk Evaluation & Mitigation Strategy, or REMS, but has been accused of feigning cooperation as a delaying tactic to build Suboxone film sales.

    These various moves have, in turn, generated pushback. Generic drugmakers have asked the FDA to deny the Citizen’s Petition (read more here). And lawsuits have been filed by Suboxone customers who charge Reckitt acted in an anti-competitive manner by conspiring to suppress generic competition and maintain high prices for its newer Suboxone film (you can read two lawsuits here and here).

    Indeed, as Knopf notes, Reckitt still has “major hurdles – transitioning everyone to film, fighting off generics, … what the FDA is doing with their citizen’s petition, huge problems with diversion and abuse, DEA breathing down their necks, getting it paid on formulary – and some serious problems with uninformed politicians who think people should not be on maintenance medications forever.”

    Nonetheless, Reuter, who also worked as a consumer safety officer in the FDA Office of Health Affairs, can clearly offer some relief. “He’s got a wealth of experience working at FDA and SAMHSA,” says Mark Parrino, president of the American Association for the Treatment of Opioid Dependence, which works with federal agencies and state substance abuse authorities on opioid treatment policy. “It is a very smart move for Reckitt to have brought someone on with his knowledge of federal regulatory and policy rulemaking.”

    Sentiment: Strong Buy

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    • So you say now (in a more recent post) that Reckitt lost their bid to stave off generics with their citizens petition? So, um what do they do with their newly hired bureaucrat? Hummmmmmmm. Seems to me that there is an entirely new method of treatment for opiate addiction on the horizon......Hummmmmmm. To make it a true blockbuster by making a BIG change in the way opiate addicts are treated overall would require someone with the knowledge of how to navigate the government bureaucracy.......Hummmmmmmmm. Someone who still might be able to put single self dosed generics where they inpatient settings. Hummmmmmmmm!

    • Guys, this is what I was trying to say yesterday. Removal of Suboxone tablets in March from the market is a HUGE opportunity for Titan's Probuphine. And almost certainly guarantees a positive FDA review since alternative treatments are needed. TTNP is headed, much, much higher as word of this gets out.

    • amodeojoe731 Feb 22, 2013 7:45 AM Flag

      Yuri, you are truly amazing at finding Probuphine related material. Thanks for all you share!

0.463Oct 30 2:14 PMEDT

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