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  1. source
    (Reuters) - The U.S. Food and Drug Administration has approved Swedish drugmaker Orexo AB's drug to treat opioid addiction, the company said on Thursday, sending its shares up as much as 14.3 percent in Stockholm.

    The tablet, Zubsolv, dissolves under the tongue. It combines the drugs buprenorphine and naloxone and will compete with similar products, Subutex and Suboxone, made by Britain's Reckitt-Benckiser Group Plc.

    Orexo said its drug offers a benefit to patients over Suboxone because less is required to achieve the same effect. It also has a menthol flavor that it said patients in a study preferred.

    Nearly three out of four prescription drug overdoses are caused by painkillers known as opioids that include such drugs as oxycodone, hydrocodone, fentanyl, methadone and codeine, according to the Centers for Disease Control and Prevention, and since 2003 have caused more overdose deaths than cocaine and heroin combined.

    In March, the FDA rejected a drug similar to Orexo's from Titan Pharmaceuticals Inc and asked for additional data proving it worked. Titan's drug, Probuphine, is a long-acting version of Suboxone that is implanted under the skin.

    To date, the market for buprenorphine has been dominated by Reckitt, a consumer goods company whose products range from cleaning supplies to condoms. Suboxone and Subutex generated sales of roughly $1.3 billion in 2012.

    Orexo said opioid dependence affects nearly 5 million people in the United States and that only 20 percent receive treatment. The company said it expects peak sales of the drug to be at least $500 million.

    Suboxone and Subutex lost market exclusivity in 2009, and while generic competitors introduced cheap copies of Subutex, they were slow to develop alternatives to Suboxone. In the meantime, Reckitt persuaded many physicians to switch from Suboxone tablets to Suboxone Film, a newer, patent-protected wafer-like strip that patients dissolve under the tongue.

    At the end of 2012, according to Reckitt, Suboxone Film had captured 64 percent of the market.

    Earlier this year, the FDA approved generic versions of Suboxone tablets from Amneal Pharmaceuticals LLC and Actavis Inc.

    The agency also said, in April, that it would not approve any generic versions of the original form of OxyContin, which could be crushed and snorted for a quick high. OxyContin's maker, Purdue Pharma LP, stopped shipping its branded version of the drug in August. It now sells a reformulated version that is less easy to abuse.

    Orexo said it expects to launch the drug in the United States around September. It said on Monday it had signed an investment and profit-sharing deal with contract sales organization Publicis Touchpoint Solutions.

    Once Publicis has recovered its investment and an agreed upon return, the amount of which was undisclosed, Publicis would receive a single digit share of the profit until the contract ends in December 2016.

    Orexo's shares were up 8 kronor, or 12.12 percent, at 74.00 on the Stockholm Stock Exchange. Earlier they rose as high as 75.50.

    (1.00 SEK = 0.149 USD)

    Toni Clarke July 4, 2013
    (Reporting by Toni Clarke in Washington; Editing by Steve Orlofsky and Richard Chang)



  1. seaturtle
    I was excited for a second because I thought a new drug was approved for Opiate/opioid addiction, but in reality it's just buprenorphine and naloxone.

    They say less of a dose is needed to achieve an effect, but I'd like to see evidence backing the claims. Perhaps they optimized the ratio of buprenorphine to naloxone? Or maybe they did nothing really and this is all a marketing gimmick?
  2. babalooj
    That confused me, as well
    I think it was meant that you need to take less of the actual tablet/strip/pill/thing, including the binders, etc
  3. gal68
    Woo Hoo!!! I am very excited for anything that can help us pill heads successfully recover!!

    Stay safe everyone.

    I wanted to elaborate a little on my feelings here. I am a hydrocodone user and have been trying to not only quit, but once I found out about Suboxone, tried it, I knew it could help me to finally become free.

    Since this time I have struggled to find Suboxone, and just a doctor who will take me as a new patient. I am grateful for more options, and maybe it will become easier for more people to regain control over their lives and take them back.

  4. 345trimethoxy
    nice to see competition
  5. Großschmackhaft
    Seems like one implant has enough Probuphine for six months in it. If it has no nasty side effects, that seems like an interesting approach to combat addiction by relivieng the patient of the responsibility of responsible administration. If they are willing to abstain from other sources of opioids that is.
  6. JustinBe
    Study from nov 2012

    New study by Orexo emphasizes importance of Zubsolv™ product characteristics in direct comparison to Suboxone® Film

    Orexo AB (Orexo) today announced the successful completion of an acceptability study comparing Zubsolv (OX219) to Suboxone Film, which is the leading product for treatment of opioid dependence. The study shows that 9 out of 10 participants would choose Zubsolv over Suboxone Film for a daily treatment.

    Zubsolv is a new sublingual tablet formulation of buprenorphine and naloxone for treatment of opioid dependence. The product is based on elements of Orexo’s proprietary sublingual platform technology, which comprises enhanced trans-mucosal absorption of active pharmaceutical ingredients, mucosal micro-particle adhesion, as well as taste masking, formulated in a rapidly disintegrating sublingual tablet. These features are important attributes for pharmaceuticals administered sublingually. Improvement in taste and dissolve time has previously been associated with an enhanced treatment adherence in opioid dependent patients(1).

    A previous preference study, which compared Zubsolv to the Suboxone Tablet, demonstrated that 8 out of 1o participants preferred Zubsolv. The current study was undertaken to assess the acceptability of Zubsolv in comparison to the Suboxone Film. The study was a cross-over trial in which 28 participants were given either Zubsolv or Suboxone Film in random order on separate study days. Key results indicate that Zubsolv was preferred by more than 8 out of 10 of the participants on all acceptance parameters tested, i.e. overall acceptability, taste masking, after taste experience, mouth-feel, and ease of administration. The study also confirmed a fast dissolve time for Zubsolv. When asked specifically about which product the participants would choose for a daily treatment, 9 out of 10 participants reported they would select Zubsolv.

    Zubsolv has been submitted and has been accepted for review by the FDA, with approval projected for July 2013 and the US launch being planned for September 2013.

    "The positive results in this study are very encouraging, and confirm that Zubsolv is well positioned to take a substantial share of the growing USD 1.5 billion market for treatment of opioid dependence. I am confident that the higher acceptability of Zubsolv will translate into an improved treatment adherence, and that it will aid in attracting a higher proportion of the five million patients currently suffering from opioid dependence into treatment. ” said Anders Lundström, President and CEO of Orexo.

    On the basis of the results from this study, a comprehensive clinical program designed to fully explore and document the therapeutic potential of Zubsolv is being initiated. The first wave of studies will cover treatment initiation, treatment adherence and patient experiences during treatment of opioid dependent people with Zubsolv, and will help further differentiate Zubsolv from its competitors.
  7. TheBigBadWolf
    I still dont understand what naloxone does in these formulations... it is reported that (this is for suboxone) the tablets CAN be misused by injecting with naloxone the same as naloxone-free subutex.
    IMV these formulation aim solely on the wallet of the patients resp. Their insurances.

    The above post containing the Company's view on its new tablet still does not give any evidence how it would be preferrable to suboxone save for the taste.
    Time dissolving microbodies in a drug with that long a half life as buprenorphine has?? Bollox.

    Same old question:
    Cui bono?

    Shareholder value, eh?

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