To Whom It May Concern,
I am writing to you to request that Reckitt-Benckiser take the necessary steps to have Buprenex approved for the treatment of opioid addiction. There is a substantial population of ‘treatment resistant’ opioid addicts in the United States who would benefit dramatically from an approved injectable Buprenorphine product for maintenance therapy.
The legal and regulatory path for allowing Buprenex to be prescribed for the treatment of opioid addiction is simple and straightforward. Following submission of safety and efficacy data to the Food And Drug Administration along with a request for a status update, Buprenex would have its Indications updated to read, “Indications And Usage: Buprenex is indicated for the relief of moderate to severe pain and for the treatment of opioid dependence.”
With this status update, Buprenex and its generic form would meet the requirements of paragraph 2 subparagraph C of the Drug Addiction Treatment Act of 2000, and would be available for office based opioid addiction treatment the same as Suboxone and Subutex.
Doctors are in a better position than legislators and special interest groups to adequately treat opioid addicts. The availability of more treatment options simply allows a greater number of tools for doctors to successfully treat their patients. The ‘British System’ of the UK allows injectable Methadone, Morphine and Diamorphine for those patients who require these therapies either as an initial and temporary first step or as a maintenance treatment. Numerous countries around the world are conducting studies and trials involving injectable opioids in the treatment of opioid addiction (Netherlands, Switzerland, Germany, Canada, etc). The clinical and harm reduction benefit of injectable opioids is all the more important given that the population of addicts who often require such treatment modalities are the highest risk individuals for legal, health and social damages.
Your company has marketed Buprenex for the purpose of treating opioid addiction in other countries (most notably France), so the safety and efficacy of this use should not be an issue. The opportunity for private institutions, doctors and interested parties to study the usefulness of Buprenex alone or in combination with a sublingual Buprenorphine preparation would add valuable information and experience to the field of addiction treatment. It is also an excellent marketing opportunity, as treatment resistant opioid addicts (those who have failed numerous treatments, including oral Methadone or sublingual Buprenorphine maintenance) are an invisible demographic to the pharmaceutical industry.
There is precedent not only in your companies own involvement in the use of Buprenex for opioid addiction abroad, but in an injectable Buprenorphine product here in the US. Titan Pharmaceuticals is currently conducting Phase III trials on its Buprenorphine depot injection ‘Probuphine’. Another injectable opioid currently being developed for opioid addiction treatment is a Hydromorphone depot injection by Axxia Pharmaceuticals.
Slowly, the United States is catching up to Europe with regards to its opioid addiction treatment laws and systems, but to make a much bigger impact, the treatment resistant addicts need to be reached. Please take the necessary steps to update the status of Buprenex. This medication could do wonderful things for countless thousands who suffer needlessly, and who have been let down by the politicians, regulators and drug manufacturers for so many years.
![:\](https://bluelight.org/xf/BL_Images/Orig_Emoji/wrygrin.gif "wry grin :\")