Suboxone Assisted Treatment
501 (c) (3) Non-Profit Corporation
(Subsidiary of Medical Assisted Treatment of America)

 

"Happy Thanksgiving"

 We at Suboxone Assisted Treatment would like to wish you and your families a very blessed and happy Thanksgiving. Many times we have so much going on in our lives that we lose sight of what we really have to be thankful for. I’d like to encourage you to take some time out of your busy day to count your blessings, enjoy your family and share a smile with those around you. A simple smile does wonders.


When you get into a tight place and everything goes against you, till it seems as though you could not hang on a minute longer, never give up then, for that is just the place and time that the tide will turn. ~Harriet Beecher Stowe

In The News

Reckitt Benckiser Plc’s Suboxone heroin-dependency treatment will probably cope better with generic competition than the company forecasts, meaning profit estimates are too low, according to investors and analysts.
Suboxone, Reckitt’s fastest-growing product, is popular with U.S. doctors, who say it can wean addicts off opiates more effectively than methadone. Protection from generic competition runs out in October and Reckitt has repeatedly said the drug’s profit and revenue will fall as much as 80 percent next year.
Nine of 11 analysts surveyed by Bloomberg say that figure is too pessimistic, as Reckitt will probably preserve sales by throwing regulatory roadblocks at competitors and improving drug delivery by creating a Suboxone film-strip that dissolves in the mouth. Suboxone sales rose 45 percent last year to 341 million pounds ($564 million), accounting for about 5 percent of revenue at the maker of Lysol cleaners and French’s mustard.
“Reckitt are always under-promising and over- delivering; there is an expectation they will do that with Suboxone,” said David Keir, investment director at Scottish Widows Investment Partnership, whose funds include 1.05 percent of Reckitt shares.
Slough, England-based Reckitt has beaten analysts’ earnings estimates for seven consecutive quarters, Bloomberg data shows. A drop of only 30 percent in Suboxone sales next year would add 6 to 7 percent to earnings per share estimates, according to Andy Smith, an analyst at ICAP Securities in London.


“Reckitt has a track record of conservatism in providing market guidance,” Smith said. He advises buying the shares. The stock rose 22 pence, or 0.75 percent, to 2,948 pence at 10:36 a.m. in London trading. Reckitt has climbed 14 percent this year, compared to the 8 percent gain of competitor Unilever NV.


Orphan Status
Of the 11 analysts interviewed by Bloomberg, only two agreed with Chief Executive Officer Bart Becht’s forecast of an 80 percent sales decline, reiterated as recently as July. Becht has said Reckitt won’t produce its own generic version of the drug.
“Our guidance is based on our best estimates, given previous experience of loss of orphan drug status, and we stick to that,” spokeswoman Andrea Dawson-Shepherd said by phone. She wouldn’t comment further, and Becht declined to be interviewed.
Until next month, Suboxone benefits from so-called orphan status, which provides an extra seven years’ exclusivity after a drug’s patent runs out. U.S. regulators grant the distinction to some medicines treating rarer conditions.
Suboxone affects the same brain receptors as morphine or heroin, without producing the same euphoric “high” or withdrawal symptoms. In 2006, 560,000 Americans aged 12 and older had abused heroin at least once in the year prior to being surveyed, according to the U.S. National Survey on Drug Use.

                                

Patients Double
Dr. Joseph Terranova prescribes Suboxone to about 70 former heroin users at a time in Long Island, New York. He says more than 50 percent of his patients come off drug dependency after using Suboxone for around 18 months. He has more than doubled the amount of patients receiving the treatment in the last year.
With no generic competition, weaning drug users off heroin using Suboxone comes at a price. The treatment sells for $576.65 for 90 tablets of 8 milligrams on drugstore.com, representing a cost of about $2,339 a year to users taking one a day.
Dr. Tom Kosten, Deputy Chair of Psychiatry and Dean for Clinical Research at Texas’ Baylor College of Medicine, says he can prescribe Suboxone for about $5 a tablet. That compares with 50 cents per dose of methadone, a traditional treatment for heroin addicts that comes with more withdrawal symptoms, a greater risk of overdose and more need for doctors’ oversight.
“There are more people who want to come in for Suboxone than we have been able to handle,” Kosten said. He has 20 patients on Suboxone at Houston’s VA medical center, compared with 120 on methadone, and expects that proportion to reverse itself by next year.


FDA Approval
Suboxone’s main ingredient, buprenorphine, was discovered in the 1960s. Naloxone, the other ingredient, makes it impossible to get high if Suboxone is ground up and injected.
Suboxone in its present form was given approval by the U.S. Food and Drug Administration in 2002 to be prescribed by registered doctors. It’s the kind of drug that would typically lose most of its sales on the first day of generic competition, according to independent pharmaceutical analyst Frances Cloud.
To delay that day, Reckitt has filed a so-called citizen petition, which calls for patient safety tests, against any generic competition that may appear. The company may also buy back the European distribution rights to the medication from Schering-Plough Corp. to hold on to revenue, according to Chas Manso de Zuniga, an analyst at Evolution Securities in London. No talks are being held on such a transaction, Monique Mols, a Schering-Plough spokeswoman in the Netherlands, said by e-mail.

 
Citizen Petition
“If no one launches a generic product, then obviously Suboxone profits will be higher than currently assumed,” said John Wilson, investment director of U.K. equities at Standard Life Investments in Edinburgh. Wilson helps manage about $200 billion of assets, including 7.26 million shares in Reckitt, or 1.02 percent of the company, Bloomberg data show.
The FDA can take up to 180 days to respond to a citizen petition. Such a petition may delay generic competition to Suboxone for a few months, “but none of the arguments are strong enough to result in a permanent ban,” according to Andrew Wood, an analyst at Sanford C. Bernstein in New York.
Still, “management’s 80 percent loss seems very extreme,” said Wood, who forecasts a 56 percent 2010 drop for Suboxone sales. With the market for such treatments still growing, “Reckitt will be losing share, but of a bigger category.”
Reckitt has completed the second of three trials generally needed for regulatory approval of the film-strip version of Suboxone, according to Bloomberg data.
The film-strip equivalent may allow the drug to enter the body more quickly and efficiently than a tablet, according to Professor Michael Colman of Aston University’s pharmacy department in Birmingham, England.
The FDA won’t approve any generic versions until after Suboxone loses orphan-drug protection on Oct. 8, Becht said last month. He declined to give any outlook on Suboxone sales in the fourth quarter. “The question is not if they come, the question is when and how many?” he said of generic rivals.
http://www.bloomberg.com/apps/newspid=20601202&sid=a3.dD8Nh5Hco


Involve yourself in the
things you believe in,
and your actions
will give you strength.
~Unknown


To Believe

To believe is to know that every day
is a new beginning.
It is to trust that miracles happen,
and dreams really do come true.
To believe is to see
angels dancing among the clouds,
To know the wonder of a stardust sky
and the wisdom of the man in the moon.
To believe is to know the value of a nurturing heart,
The innocence of a child's eyes
and the beauty of an aging hand,
for it is through their teachings we learn to love.
To believe is to find the strength
and courage that lies within us.
When it is time to pick up the pieces
and begin again.
To believe is to know
we are not alone,
That life is a gift and
this is our time to cherish it.
To believe is to know that wonderful surprises
are just waiting to happen,
And all our hopes and dreams are within reach.
If only we believe.
~unknown

The FDA web site announced on October 9th that a generic form of buprenorphine from Roxane Pharmaceuticals has been approved.
I have researched the Internet for reactions to the approval and you can read those comments below. Please bear in mind that these are the opinions of others and may not be the opinion of the staff here at Suboxone Assisted Treatment.

Given the high price of Suboxone and Subutex in the pharmacies we have all eagerly awaited the arrival of cheaper alternatives. While I am glad more patients will be able to afford treatment with adequate doses, I believe many will want to switch from Suboxone to generic buprenorphine, and that this will lead to more abuse and diversion. Delay in release of the buprenorphine until after release of the combination could have prevented this. What could the FDA have been thinking?

Increase in buprenorphine availability accompanied by lower price on the street may also lead more addicts to attempt to treat themselves rather than incurring the expense of medical supervision. And since many patients (and even a few docs) seem to wrongly assume that precipitated withdrawal results from the naloxone, we may see an increase in that phenomenon when naive addicts use the drug too soon after stopping whichever full agonist they were dependent upon.

Let us hope the FDA approves a generic buprenorphine/naloxone product post haste and that its price makes it just as much of a bargain as buprenorphine alone for saving lives and do not switch from the combination to the new generic for financial reasons alone.  http://behavenetopinion.blogspot.com/2009/10/is-generic-buprenorphine-approval.html

What do you think? I'd like to hear from you. Please send me an email with your comments to dee.vicepresident@medicalassistedtreatment.org

A survey of intravenous drug users in the Helsinki area has found that buprenorphine, which is sometimes used for helping heroin users shake off their addiction, is currently the most frequently-used IV drug in the region, and all of Finland.
According to the study by the National Public Health Institute, 70 percent of IV drug users surveyed in the Helsinki area said that their primary drug of choice is buprenorphine. Five years ago a study by the National Research and Development Centre for Welfare and Health (STAKES) revealed that amphetamine was the preferred IV drug.
There are fears that illicit use of buprenorphine will increase further. In the summer the patent for buprenorphine, which is most commonly sold under the brand names Subutex and Temgesic, expired, allowing cheaper generic versions onto the market.
Hannu Alho head physician at the National Public Health Institute, expects that that more of the drug will appear on the illicit market.
When prescribed as a substitute for heroin, Subutex and Temgesic are taken sublingually in pill form. However, the price is high on the illegal market, and users make the pills go further by crushing, dissolving, and injecting the drug.
Legal access to buprenorphine has been very restricted in Finland, and addicts have travelled to the Baltic States to get prescriptions. Latvia and Estonia recently clamped down on buprenorphine prescriptions for foreigners, forcing Finns who need it to travel to France where prescriptions are still available.
Hannu Alho wants Finland and France to reach the same kind of agreement that Finland has with Estonia and Latvia, where buprenorphine is now prescribed only to those Finns who are undergoing opiate withdrawal treatment in those countries.
Buprenorphine abuse is a typically Finnish phenomenon. New Zealand is the only other country where the problem has reached similar proportions.

Buprenorphine is relatively safe when used on its own. However, when combined with alcohol or certain other drugs it can be deadly.
Buprenorphine is currently the most frequently detected drug in post-mortems, replacing heroin, which held the top spot in 2000.

The National Public Health Institute survey was conducted in the spring of 2005. During two weeks, about 600 customers of needle exchange centers were asked to fill in a questionnaire. About one in three agreed to take part in the anonymous and voluntary survey.

"We repeated the study this spring. The results have not yet been analyzed, but it appears that the situation has not changed very much", Alho says.
Finland has an estimated 16,000 - 21,000 intravenous drug users, 30 - 40 per cent of whom live in the Helsinki region. http://www.hs.fi/english/article/Generic+buprenorphine+could+increase+illicit+use+of+drug/1135223349939

Did you know?
World War I officially ended on June 28, 1919, with the signing of the Treaty of Versailles. The actual fighting between the Allies and Germany, however, had ended seven months earlier with the armistice, which went into effect on the eleventh hour of the eleventh day of the eleventh month in 1918. Armistice Day, as November 11 became known, officially became a holiday in the United States in 1926, and a national holiday 12 years later. On June 1, 1954, the name was changed to Veterans Day to honor all U.S. veterans. In 1968, new legislation changed the national commemoration of Veterans Day to the fourth Monday in October. It soon became apparent, however, that November 11 was a date of historic significance to many Americans. Therefore, in 1978 Congress returned the observance to its traditional date.


I keep my mind focused on peace, harmony, health, love and abundance. Then, I can’t be distracted by doubt, anxiety, or fear.
~Edith Armstrong

Our greatest glory is not in never falling but in rising every time we fall.
~Confucius

The best way to prepare for life is to begin to live.
~Elbert Hubbard


This month our new Suboxone Forum; "The Light At The End Of The Tunnel" celebrated it's first aniversary. With over 200 members we have all of you who visit our website to thank. Without you, we coudn't have done it. Our members mean the world to us. With your continued support I'm sure that the next year will be just as successful.

This brings another month to a close. Please before you leave don't forget to sign out guestbook. We love your comments. If you haven't already joined our forum, please do. Education along with support is the key to a successful recovery.

Don't forget! We are available to you 24 hours a day, 7 days a week. Give us a call. If you cannot afford to call us, send us an email and we will call you at our expense.

Cell- (770)527-9119
Office- (770)334-3655
Facsimile:  (770)334-3704
Email: dee.vicepresident@SuboxoneAssistedTreatment
 

Compiled and published by:
Dee Black
Assistant Editor/Research Assistant/Forum Manager
Approved By:
Deborah Shrira CEO/Editor/Web Mistress
Medical Assisted Treatment of America Inc.
November 2009