Opioid dependence: BDSI offers advantages over RB's Suboxone
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`Opioid dependence treatment from
`BDSI aims to challenge RB’s
`Suboxone
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`April 12, 2012 12:28 pm by Frank Vinluan | 2 Comments
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`As drug abuse grows and drug addiction specialists seek new ways to treat
`opioid dependence, BioDelivery Sciences International (NASDAQ:BDSI) is
`positioning itself to enter that market as early as next year.
`
`BDSI plans to file a new drug application for its opioid dependence treatment
`BEMA Buprenorphine in the first half of 2013. Like current market leader
`Suboxone, sold by Reckitt Benckiser (LSE:RB), BEMA Buprenorphine would
`be administered via a small piece of film that dissolves in the mouth. But
`BDSI believes differences in its drug delivery technology would give it the
`edge over Suboxone. BDSI will need an advantage to take on RB’s
`blockbuster drug, which generated more than $1.2 billion in 2011 sales.
`
`BEMA Buprenorphine could become the second transmucosal product on
`the market to treat opioid dependence and it has the potential to reach sales
`of $300 million, CEO Mark Sirgo told a New York audience of investors and
`analysts during a presentation on Wednesday. He was joined by two
`addiction medicine specialists, Dr. Gregory Sullivan, medical director at
`Parkway Medical Center in Birmingham, Alabama, and Dr. Aafaque Akhter
`of Norton Healthcare in Norton, Massachusetts.
`
`Opioid dependence
`has long been
`treated by
`methadone. But
`buprenorphine’s
`2002 entrance into
`the market offered an
`
`South Dakota
`startup raises $1M
`for its “eyegraine”
`system that treats
`vision-related
`migraines
`Meghana Keshavan | 6:00 am, November 5
`
`http://medcitynews.com/2012/04/opioid-dependence-treatment-from-bdsi-aims-to-challeng...
`
`11/5/2014
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`Page 1
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`RB Ex. 2039
`BDSI v. RB PHARMACEUTICALS LTD
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`Opioid dependence: BDSI offers advantages over RB's Suboxone
`
`Page 1 of 4
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`Sectio n s
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`
`Health IT Hospitals Medical Devices
`
`Pharma
`
`Politics
`
`Startups Connected Care
`
`Opioid dependence treatment from
`BDSI aims to challenge RB’s
`Suboxone
`
`April 12, 2012 12:28 pm by Frank Vinluan | 2 Comments
`
`Like
`
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`GOT NEWS? SEND US A TIP
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`LATEST STORIES
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`People moves: DreamIt Ventures CEO
`Kerry Rupp to step down and focus on
`fund 2:10 pm
`
`Ebola Watch: Scientists need virus
`samples now for potential vaccine 1:43 pm
`
`Sex, drugs, and the managing director of
`healthcare practices for investment bank
`Jefferies 11:52 am
`
`2014 election results: Abortion and
`Medicaid 10:49 am
`
`FROM THE MEDCITY TEAM
`
`People moves:
`DreamIt Ventures
`CEO Kerry Rupp to
`step down and focus
`on fund
`Stephanie Baum | 2:10 pm, November 5
`
`As drug abuse grows and drug addiction specialists seek new ways to treat
`opioid dependence, BioDelivery Sciences International (NASDAQ:BDSI) is
`positioning itself to enter that market as early as next year.
`
`BDSI plans to file a new drug application for its opioid dependence treatment
`BEMA Buprenorphine in the first half of 2013. Like current market leader
`Suboxone, sold by Reckitt Benckiser (LSE:RB), BEMA Buprenorphine would
`be administered via a small piece of film that dissolves in the mouth. But
`BDSI believes differences in its drug delivery technology would give it the
`edge over Suboxone. BDSI will need an advantage to take on RB’s
`blockbuster drug, which generated more than $1.2 billion in 2011 sales.
`
`BEMA Buprenorphine could become the second transmucosal product on
`the market to treat opioid dependence and it has the potential to reach sales
`of $300 million, CEO Mark Sirgo told a New York audience of investors and
`analysts during a presentation on Wednesday. He was joined by two
`addiction medicine specialists, Dr. Gregory Sullivan, medical director at
`Parkway Medical Center in Birmingham, Alabama, and Dr. Aafaque Akhter
`of Norton Healthcare in Norton, Massachusetts.
`
`Opioid dependence
`has long been
`treated by
`methadone. But
`buprenorphine’s
`2002 entrance into
`the market offered an
`
`South Dakota
`startup raises $1M
`for its “eyegraine”
`system that treats
`vision-related
`migraines
`Meghana Keshavan | 6:00 am, November 5
`
`http://medcitynews.com/2012/04/opioid-dependence-treatment-from-bdsi-aims-to-challeng...
`
`11/5/2014
`
`Page 1
`
`

`

`Opioid dependence: BDSI offers advantages over RB's Suboxone
`
`Page 2 of 4
`
`alternative.
`Buprenorphine
`reduces drug
`cravings and, unlike
`methadone, can be
`used on an
`outpatient basis,
`Sullivan said. Also, unlike methadone, it does not give drug addicts any
`highs. Sullivan calls buprenorphine a “miracle drug.”
`
`Advertisement
`
`Akhter said that heroin is no longer the opiate of choice. Most opiate
`addiction is associated with pain killers. His typical patient is someone who
`was prescribed opiates for surgical pain and got hooked. Buprenorphine led
`to a surge in treatment for those patients, he said.
`
`RB’s Suboxone combines buprenorphine with naloxone, another drug that
`deters drug abuse. Suboxone was first developed as a tablet placed under
`the tongue. RB later developed a dissolvable film version, also placed under
`the tongue. The product’s sale grew as buprenorphine continues to grow as
`an opioid dependence treatment option. The Suboxone film is the only
`transmucosal product available. But Suboxone’s drawback has been an
`unpleasant taste. Sullivan said nearly all of his patients complain about the
`taste, but they have had no alternative.
`
`“We need more options and this is definitely one,” Sullivan said.
`
`Suboxone also presents another issue for patients and prescribers. Because
`the product is placed under the tongue, it causes the mouth to produce a lot
`of saliva. Andrew Finn, BDSI’s executive vice president for product
`development, said that the saliva production leads to much of the active drug
`being swallowed rather than absorbed into the bloodstream. BDSI’s
`technology delivers medication through a piece of film placed on the inside
`of the cheek. Finn said that a second layer on the film prevents the
`buprenorphine from coming out and mixing with the saliva and then being
`swallowed. That means BDSI’s product needs to administer less medication
`than Suboxone to have an effect.
`
`Like Suboxone, BEMA Buprenorphine combines buprenorphine and
`naloxone in a single transmucosal product. BDSI is developing BEMA
`Buprenorphine through the U.S. Food and Drug Administration’s 505(b)(2)
`pathway, which allows the company to seek approval by showing its product
`is bioequivalent to the already-approved Suboxone. A series of studies
`requested by the FDA are ongoing or on track to start in 2012. The last
`study, a safety study in opioid dependent patients, is expected to produce
`data in the first quarter of next year. BDSI expects it will be in position to file
`a new drug application shortly after.
`
`[Photo from stock.xchng user Julia Freeman-Woolpert]
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`Opioid dependence: BDSI offers advantages over RB's Suboxone
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`By Frank Vin luan
`Frank Vinluan is the North Carolina Bureau Chief for
`MedCity News.
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`Opioid dependence: BDSI offers advantages over RB's Suboxone
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