Kratom and scheduling by DEA

 

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What the Scheduling of Kratom by the DEA Means for Research

At the end of August 2016, the Drug Enforcement Administration (DEA) announced its intent to place the active components of kratom into Schedule I of the Controlled Substances Act, due to 15 known deaths related to kratom between 2014 and 2016, as well as its “high potential for abuse,” and lack of an “accepted medical use… in the United States.”

However, due to a widespread outcry, including a letter to the DEA from 51 members of Congress, questioning the decision and a lack of opportunity for public comment, the DEA is placing a hold on this decision.

The status moving forward is uncertain, as the DEA has not issued a public statement, but it is hoped the organization will seek out input from the public before reaching a decision. The original intent to place kratom in the Schedule I category was invoked using a rarely used emergency power that states the DEA need only issue a 30 day notice.

“The DEA’s decision to place kratom as a Schedule I substance will put a halt on federally funded research and innovation surrounding the treatment of individuals suffering from opioid and other addictions,” the members of Congress wrote in their letter to Charles P. Rosenberg, the Acting Administrator of the DEA, and to the director of the White House Office of Management and Budget.

“This significant regulatory action was done without any opportunity for public comment from researchers, consumers and other stakeholders… This hasty decision could have serious effects on consumer access and choice of an internationally recognized herbal supplement.”

Some kava bar owners as well as the American Kratom Association (AKA), an organization of kratom consumers which receives some of its funding from kratom vendors, are taking action against the proposed scheduling of kratom, questioning the DEA’s hasty decision and the quality of the research on which their decision is based.

David Fox and Lynn Mehler, partners in the Los Angeles-based law firm of Hogan Lovells, wrote a letter to the DEA stating, “AKA takes very seriously DEA’s concern that approximately 30 reports of fatalities have been linked to consumers who had ingested or possessed a kratom product. However, a close examination of these reports shows that there are no instances in which kratom itself was determined to be responsible for the cause of death[…] There is good reason to question whether these reports indeed represent a valid or meaningful signal with respect to kratom. Close review of the totality of evidence points clearly in the other direction, namely, that kratom is well tolerated and relatively mild in its effects.”

Impeding Research Opportunities?

Kratom comes from a tree in southeast Asia, the Mitrargyna speciosa korth. Its active ingredients, the opioids mitragynine and 7-hydroxymitragynine, make it a popular alternative to opioids for treating pain and for easing opioid withdrawal.

Given the opioid epidemic in the United States, researchers are hoping to find treatments for pain that are nonaddictive.

Compounds derived from the active ingredients in kratom look promising: recent research published in the Journal of Medicinal Chemistry, conducted by Susruta Majumdar, PhD, assistant attending chemist at the Memorial Sloan Kettering Cancer Center and colleagues, found that mitragynine pseudoindoxyl, a semi-synthetic opioid derived from mitragynine, one of the active ingredients in Kratom, appeared to more effectively relieve pain in mice, compared with morphine, without many of the dangers and unpleasant adverse effects caused by opioids.1

“In vitro, mitragynine pseudoindoxyl and its analogs were potent agonists in [35S] GTPγS assays at the µ-opioid receptor but failed to recruit β-arrestin-2, which is associated with opioid side effects,” the authors wrote.

“Additionally, mitragynine pseudoindoxyl developed analgesic tolerance more slowly than morphine, showed limited physical dependence, respiratory depression, constipation, and displayed no reward or aversion in Conditioned Place Preference assays, suggesting that analogs might represent a promising new generation of novel pain relievers,” they added.

Placing kratom in Schedule I of the Controlled Substances Act would impede its acquisition for research purposes forcing online kratom vendors to shut down. Researchers would have no efficient way to acquire mitragynine to produce mitragynine pseudoindoxyl, which can take as long as 5 years to create in the lab in the absence of the plant.

This seems to create a conundrum: one of the reasons the DEA cites for banning kratom is a lack of evidence for its medical use. However, if kratom is banned and becomes significantly more difficult to acquire for research, its interest for clinic use may not be demonstrated.

A similar situation exists with marijuana,  also a Schedule I drug with medical potential, difficult to acquire for research purposes.

As recently as August 11, the DEA rejected 2 petitions to downgrade marijuana scheduling, which would have allowed researchers to acquire it more easily. Unfortunately, much of the issue may lie with the Controlled Substances Act itself, which has no category for substances considered too dangerous to leave unregulated, but that may have medical potential if researched.

A categorization of kratom in Schedule I by the DEA would last for 2 years, with an option to extend it to 3, while the DEA and US Food and Drug Administration examine whether kratom has an accepted medical use and decide whether to make the Schedule I categorization permanent.

With kratom in Schedule I, researchers would have to apply for a Schedule I research license and hope that the DEA would be able to supply enough quality kratom to all of those hoping to study it, although it is unclear how they would do so.

Buprenorphine (Suboxone) versus Methadone in pregnancy: The latest

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NOVA Addiction Specialists – facebook – Alexandria, Virginia

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Suboxone doctor locator – Alexandria, Virginia

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Probuphine Healthcare Provider Locator

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A retrospective review of Buprenorphine versus methadone treatment in pregnancy in the latest Journal of Addiction:

methadone-and-buprenorphine-for-opioid-dependence-during-pregnancy  < Article Link

Abstract below:

Objectives: To compare maternal characteristics, prenatal care, and newborn outcomes in a cohort of opioid-dependent pregnant women treated with methadone versus buprenorphine.

Methods: In a retrospective cohort study, 609 pregnant, opioiddependent women were treated with methadone (n = 248) or buprenorphine (n = 361) between 2000 and 2012 at a single institution.

Results: Mothers treated with buprenorphine were more likely to start medication before or earlier in pregnancy, had longer gestation, and gave birth to larger infants. Newborns of buprenorphine- versus methadone-maintained mothers required treatment for neonatal abstinence significantly less often and for a shorter duration.

Conclusions: These data suggest pregnancy outcomes with buprenorphine to treat opioid dependence during pregnancy in clinical practice are as good and often better than outcomes with methadone. These results are consistent with efficacy data from randomized clinical trials and further support the use of buprenorphine for the treatment of opioid dependence during pregnancy.

Suboxone doctors 22314 – Virginia

Kratom – and it’s impending ban

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kratomphoto

Links to Kratom images

Kratom’s user guide

What is kratom?
Kratom is a tree native to Southeast Asia (Thailand, Malaysia, Indonesia, Borneo, etc.). Its botanical name is Mitragyna speciosa. Kratom is in the same family as the coffee tree (Rubiaceae). The leaves of kratom have been used as an herbal drug from time immemorial by peoples of Southeast Asia. It is used in folk medicine as a stimulant (at low doses), sedative (at high doses), recreational drug, pain killer, medicine for diarrhea, and treatment for opiate addiction. Many people report that kratom is an effective treatment for arthritis, restless legs syndrome (RLS), and fibromyalgia.

How is it taken?
In its native region, kratom leaves are often chewed fresh (usually after removing the stringy central vein). Dried leaves can also be chewed, but since they are a bit tough, most people prefer to crush them up or powder them so that they can be swallowed easily. Powdered kratom can be mixed with water and then drunk. This method is quick and easy. It can also be mixed with other liquids, such as fruit juice, milk, or kefir. Chocolate milk works especially well for masking the taste. Powdered kratom can also be made into a paste that can easily be swallowed with water. The powder can also be mixed with applesauce or yogurt. It can also be put into capsules. Dried kratom leaves are often made into a tea that is strained and then drunk. Kratom can be smoked, but doing so is impractical because the amount of leaf that constitutes a typical dose is too much to be smoked easily. A resin-like extract can be prepared by evaporating the water from kratom tea. This can be stored for later use. Small pellets of this extract can be swallowed, or it can be dissolved in hot water and consumed as a tea. Some people like to mix kratom tea with ordinary black tea, or other herbal teas, before it is consumed. This is done to make it more palatable. Sugar or honey can be added to sweeten it.

Kratom still legal, for now; Austin advocates continue their fight

DEA statement regarding Kratom use

DEA Announces Intent to Schedule Kratom
SE Asian drug is imminent hazard to public safety

AUG 30 (WASHINGTON) – The Drug Enforcement Administration (DEA) today announced its intention to place the active materials in the kratom plant into Schedule I of the Controlled Substances Act in order to avoid an imminent hazard to public safety. Mitragynine and 7-hydroxymitragynine are found in kratom, which is a tropical tree indigenous to Thailand, Malaysia, Myanmar, and other areas of Southeast Asia.  The announcement was made in the U.S. Federal Register and can be found by following thislink.

Kratom is abused for its ability to produce opioid-like effects and is often marketed as a legal alternative to controlled substances. Law enforcement nationwide has seized more kratom in the first half of 2016 than any previous year and easily accounts for millions of dosages intended for the recreational market, according to DEA findings.  In addition, kratom has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and has a lack of accepted safety for use under medical supervision. These three factors constitute a Schedule I controlled substance according to the Controlled Substances Act passed by Congress in 1970.

Kratom has been seized by law enforcement in various forms, including powder, plant, capsules, tablets, liquids, gum/resin, and drug patch. Because the identity, purity levels, and quantity of these substances are uncertain and inconsistent, they pose significant adverse health risks to users. 

From February 2014 to July 2016, over 55,000 kilograms of kratom material were encountered by law enforcement at various ports of entry within the United States. Additionally, another 57,000+ kilograms of kratom material offered for import into the United States between 2014 and 2016 are awaiting an FDA admissibility decision. Together, this material is enough to produce over 12 million doses of kratom. The FDA has also warned the public not to use any products labeled as containing kratom due to concerns about toxicity and potential health impacts. In addition, FDA has issued and updated two import alerts related to kratom products.  Kratom has been on DEA’s list of drugs and chemicals of concern for several years.

The American Association of Poison Control Centers identified two exposures to kratom from 2000 and 2005.  Between 2010 and 2015, U.S. poison centers received 660 calls related to kratom exposure. The Center for Disease Control (CDC) found that kratom abuse leads to agitation, irritability, tachycardia,  nausea, drowsiness, and hypertension. Health risks found in kratom abusers include hepatotoxicity, psychosis, seizure, weight loss, insomnia, tachycardia, vomiting, poor concentration, hallucinations, and death. DEA is aware of 15 kratom-related deaths between 2014 and 2016.

Lawmakers have asked that the ban on Kratom be delayed:

Lawmakers document letter to delay ban on Kratom

Dear Colleague Letter

PREVENT DRUG ENFORCEMENT AGENCY OVERREACH AND PRESERVE CONSUMER ACCESS TO NATURAL HERBAL SUPPLEMENT KRATOM  

Join Rep. Mark Pocan in Urging the Office of Management and Budget and the Drug Enforcement Agency to Delay Final Action Listing Kratom as a Schedule I substance under the Controlled Substances Act

Deadline Tuesday September 20th COB

Dear Colleague:  

I invite you to join me in sending a bipartisan letter to the Drug Enforcement Agency to encourage more research into the natural supplement, Kratom. Kratom (Mitragyna speciosa) is made from the leaves of a tropical tree native to Southeast Asia and a relative of the coffee plant. Kratom leaves are often brewed like a tea, or crushed and mixed with water. In the U.S., kratom has become popular among people coping with chronic pain and others trying to wean themselves off opioids or alcohol.

The main chemical is mitragynine. It binds to some of the same receptors as opioids, providing some pain relief and a calming effect, but, not the same high. And the chemical doesn’t cause the same, sometimes deadly, side effects as opioids, such as respiratory depression.

On August 31, the Drug Enforcement Agency published a “notice of intent” in the Federal Register stating its plan to list the herb as a Schedule I substance, the most restrictive category, alongside heroin and LSD, effective September 30th with no opportunity for a public comment period.  

The National Institutes of Health has funded a joint study conducted by the University of Massachusetts and the University of Mississippi to investigate the use of kratom as a remedy for opioid withdrawal. This study led the researchers to apply for a patent identifying the kratom extract, mitragynine, as a useful treatment for other addictive drugs besides opiate derivatives. The DEA’s decision to place kratom as a Schedule I substance will put a halt on federally funded research and innovation surrounding the treatment of individuals suffering from opioid and other addictions—a significant public health threat.

The letter asks the Director of OMB and Acting Director of the DEA to delay a final decision on the placement of Kratom as a schedule I, provide ample time for public comment on this significant decision, and resolve any inconsistencies with other Federal Agencies regarding the use of Kratom.  

Please join me in this effort to prevent the DEA from regulatory overreach and restricting consumer access to this natural herbal supplement. If you have questions or would like to sign on to the letters, please contact Leslie Zelenko in Rep. Mark Pocan’s office at 202-225-2906 or Leslie.Zelenko@mail.house.gov.  

Sincerely,  

Mark Pocan

Member of Congress  

The Honorable Charles P. Rosenberg  Administrator (Acting)  Drug Enforcement Administration  Lincoln Place-West  700 Army Navy Drive  Arlington, VA 22202  

September X, 2016  

Dear Acting Administrator Rosenberg:  

We write with concern about your agency’s proposed regulatory decision to utilize section 201 of the Controlled Substance Act (CSA) to temporarily place Mitragynine and 7-Hydroxymitragynine, more commonly known as Kratom, into schedule I of the CSA. We urge your agency to delay a final decision on the placement of Kratom as a schedule I, provide ample time for public comment on this significant decision, and resolve any inconsistencies with other Federal Agencies regarding the use of Kratom.  

As our nation continues to combat the public health crisis of opioid abuse, the federal government has invested significant resources to develop alternative pain management strategies. This includes a study funded by the National Institutes of Health in partnership with the University of Massachusetts and the University of Mississippi to investigate the use of Kratom as a remedy for opioid withdrawal. This study led the researchers to apply for a patent identifying the Kratom extract, mitragynine, as a useful treatment for other addictive drugs besides opiate derivatives. The DEA’s decision to place Kratom as a Schedule I substance will put a halt on federally funded research and innovation surrounding the treatment of individuals suffering from opioid and other addictions—a significant public health threat.  

DEA’s Federal Register notice posted on August 31, 2016 proposes placing Kratom in the most restrictive category- schedule I- within 30 days. This significant regulatory action was done without any opportunity for public comment from researchers, consumers, and other stakeholders. This hasty decision could have serious effects on consumer access and choice of an internationally recognized herbal supplement.  

We urge the DEA to delay finalizing the decision to define Kratom as a schedule I substance under the Controlled Substances Act and to engage consumers, researchers, and other stakeholders, in keeping with well-established protocol for such matters. A departure from such guidelines threatens the transparency of the scheduling process and its responsiveness to the input of both citizens and the scientific community. We look forward to your timely response.  

 Sincerely,  

The Honorable Shaun Donovan Director Office of Management and Budget 725 17th Street, NW Washington, DC  20503  

September X, 2016  

Dear Director Donovan:  

We urge you to use your statutory authority to require the Drug Enforcement Agency (DEA) to delay their proposed regulatory action to temporarily place Mitragynine and 7-Hydroxymitragynine, more commonly known as Kratom, into schedule I of the Controlled Substances Act (CSA), until there is sufficient opportunity for public comment and Federal Agencies to work out discrepancies between them in terms of their understanding of the use of Kratom.  

The DEA published their notice of intent in the Federal Register on August 31, 2016, only 30 days before they plan to finalize this decision to place this substance in the most restrictive classification under CSA. The Agency did not provide any public comment process for this significant regulatory decision, which will restrict consumer choice and access to internationally recognized herbal product. We believe the Office of Information and Regulatory Affairs (OIRA), under your jurisdiction, must utilize its statutory authority to manage and oversee this specific regulatory action to ensure the DEA is not violating federal law.    

In the Federal Register notice to temporarily place Kratom as a Schedule 1 substance under the CSA, the DEA references that “available data and information for mitragynine and 7-hydroxymitragynine indicate that these substances have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.” However, researchers at University of Massachusetts and the University of Mississippi received two National Institutes of Health (NIH) grants to investigate the use of Kratom as a remedy for opioid withdrawal. This led the researchers to apply for a patent identifying the Kratom extract, mitragynine, as a useful treatment for other addictive drugs besides opiate derivatives.  The DEA’s decision to place Kratom as a Schedule I substance will put a halt on federally funded research and innovation surrounding the treatment of individuals suffering from opioid and other addictions—a significant public health threat.  

Due to the short time frame provided by the DEA’s decision, we urge your agency to immediately utilize your statutory authority and delay the process to place Kratom in schedule I

until sufficient public comment is received and inconsistencies between Federal Agencies view of the product are addressed. We look forward to your timely response.  

Sincerely,  

 

A petition had been sent to congress regarding the ban as well:

Petition to Congress regarding Kratom ban << Link

AUSTIN (KXAN) — A federal decision to make the herbal supplement kratom as illegal as heroin is now on hold.

Lawmakers have asked the Drug Enforcement Agency to delay the final decision, saying the move to ban it was hasty and there was no opportunity for public comment.Dozens have also signed on to a letter to Shaun Donovan, director of the Office of Management and Budget, to use his “statutory authority” to delay the DEA from labeling kratom as a Schedule I substance.

In late August, the DEA announced its intent to place the active materials found in the kratom plant into Schedule I of the Controlled Substances Act, citing concerns that the supplement was a public health hazard. They believe there’s a high potential abuse and say the number of calls to poison centers increased tenfold over five years.

But the decision caused a major backlash, not only from lawmakers but from more than 140,000 people who signed a White House petition to keep kratom legal.

Kratom is a tropical tree found in Southeast Asia, and its leaves can be crushed into a powder for users to take. Many swear by its medicinal benefits, using it for chronic pain relief, depression, anxiety and post traumatic stress disorder.

For users like 35-year-old Austin mom Ciara Gammon, it helped her get off the painkillers which she had been prescribed for years.

Gammon broke her neck at age 14 and later learned she had a herniated disc. Complications in her neck continued and doctors prescribed her heavy medication like Norco and Soma.

“I felt like a pain in everybody else’s life because all I could basically do was take drugs and lay in bed, and they were drugs the pharmacy and doctor said I had to have,” said Gammon.

While she was skeptical, Gammon eventually tried kratom, and says it changed her life.

“My daughter, if she wasn’t in school right now, would be more than willing to tell you that it gave her mother back, for the first time in her life,” said Gammon. “Kratom just gives you the ability to stabilize your mood, stabilize pain, be the normal human being that you really are inside before you were taken over by this thing you can’t fight.”

Her best friend Amy Shelbourne also relies on kratom. Her pain also started at a young age, suffering from Endometriosis and severe complications down the road.

“I had a complete hysterectomy and several surgeries to clean up all the scar tissue, take a few organs that were damaged. So that was when I really started heavily using all the medication they gave me, fentanyl, dilaudid, oxycontin, oxycodone,” said Shelbourne. “Four months ago I completely stopped taking over-the-counter and prescription medicine, I don’t take anything but kratom now, not even ibuprofen.”

She too says it’s changed her life, and it’s why she’s now publicly fighting to keep it legal.

“Helps keep me up and motivated and happy and not so depressed with the pain, because the pain is still there — it just makes life doable,” said Shelbourne. “This has saved my life, this had made me be able to be a wife again.”

The two women know their fight isn’t over, and hope the DEA listens to their stories before making their final decision.

KXAN reached out to the DEA and did not receive a response.

Kratom advocates petition to keep drug on shelves

 

 

New Zubsolv Buprenorphine and Naloxone tablet form

U.S. FDA Approves Orexo’s Low Dose ZUBSOLV® Buprenorphine and Naloxone Sublingual Tablets (CIII)

The FDA has approved Zubsolv (buprenorphine/naloxone CIII sublingual tablets) 0.7mg/0.18mg for the treatment of patients with opioid dependence.

This expands the doses available for Zubsolv to six different dosages (11.4mg/2.9mg, 8.6mg/2.1mg, 5.7mg/1.4mg, 2.9mg/0.71mg, 1.4mg/0.36mg & 0.7mg/0.18mg). The drug was originally approved in 2013.

Adverse events commonly reported with the use of Zubsolv include headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

Reference:

Orexo. U.S. FDA Approves Orexo’s low dose Zubsolv® buprenorphine and naloxone sublingual tablets (CIII) [press release]. October 6, 2016. http://www.prnewswire.com/news-releases/us-fda-approves-orexos-low-dose-zubsolv-buprenorphine-and-naloxone-sublingual-tablets-ciii-300340469.html.

 

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