FDA signals crackdown on controversial painkiller

pharmafile | November 15, 2017 | News story | Medical Communications, Research and Development biotech, drugs, kratom, pharma, pharmaceutical 

Scott Gottlieb, the FDA’s Commissioner, issued an advisory about the medicinal plant-product known as kratom. The plant is known to act as a stimulant in low-doses and has opioid-like effects in higher doses, but whether it is directly harmful is a matter of serious debate.

The plant has been used in Asia, where it originates, as a natural remedy for numerous ailments and, like the coca plant in Central and South America, has been used as a stimulant by labourers to maintain energy for centuries.

However, the FDA points out that it that due to its opioid-like effects, it has the potential be abused; Gottlieb noted that 36 deaths are associated with the use of the plant, though researchers into the drug and advocates have countered that, in each case, it was through use with various other drugs.

Advocates of the use of kratom point to the fact that users have successfully managed battle more dangerous addictions through self-medicating with the plant. Researchers of the plant have also argued that the action of the chemicals within are not yet fully understood, and that further research needs to be conducted to determine whether there is therapeutic potential.

Gottlieb explained the reasoning behind looking the agency’s worries in his statement: “I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence. The FDA has a well-developed process for evaluating botanical drug products where parties seek to make therapeutic claims and is committed to facilitating development of botanical products than can help improve people’s health. We have issued guidance on the proper development of botanical drug products. The agency also has a team of medical reviewers in the FDA’s Center for Drug Evaluation and Research that’s dedicated to the proper development of drug applications for botanicals. To date, no marketer has sought to properly develop a drug that includes kratom.”

Though no application has yet been made, the pharmaceutical company, Trevena, is developing a drug with a compound found in the kratom plant. The experimental pain reliever, known as PZM21, has been studied in mice and was found to be effective, without exhibiting addictive qualities and is not a respiratory depressant.

The latter is important, as many deaths at the hands of opioids are as a result of the issues with respiratory issues – as most opioids act as a serious respiratory depressant, when users overdose, death is often from failure of the respiratory system. Any alternative pain-killer that did not exhibit this symptom could then vastly reduce the number of deaths from abuse of the drugs.

However, it is likely the FDA’s public warning on the risks of kratom signal that the agency is beginning to look at cracking down on abuse of the plant. Previously, the DEA had tried to schedule the drug into the most serious category, Schedule 1, but reconsidered its position after strong opposition.

Ben Hargreaves

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