The latest regulatory victory may develop the market of the drug
Investors in psycho-altering drugs like cannabis, often talk passionately about their potential to take a stake in the $20 billion-plus market for opioids and possibly resolve a dependence epidemic along the way.
Now, an under-scrutiny drug has been added to the list of promising disruptors. It’s also sparking interest from the big biopharmaceutical company Atai Life Science, which is known for adding psychedelic compounds into its clinical studies. Moreover, a late decision from the WHO could help mobilize it on the market, even further.
This substance is known as Kratom and it’s made from the ground leaves of a psychoactive plant that grows natively in S.E Asia. The Kratom market is already worth a whopping $1.3B in the U.S. alone, with most sales made online and in tobacco shops, based on American Kratom Association benefits. It also belongs to the list of most commonly taken substances globally among drugs categorized as “new” by the U.N. Millions of people take Kratom for pain relief and to relieve symptoms of opiate withdrawal or just for occasional use.
U.S. regulatory organizations have attempted to ban the use of Kratom for many years, but they have encountered the objection of some members of Congress. Kratom users are also so nicely organized and involved that they have been found to bombard their state representatives with multiple letters, any time there is progress on the matter.
Even though the substance isn’t illegal in the U.SSome states have their limitations and the FDA has seized supplements that contain the substance.
A closely monitored WHO panel reached a consensus back on December 7, that kratom did not guarantee a “critical review,” which might potentially lead to UN limitations and a nationwide ban. The WHO panel has concluded that while Kratom can be dangerous in very high amounts, there is not a clear association between Kratom and deaths by overdose.
Proponents support the decision to mitigate stigmas and encourage business opportunities. Marketing and advocacy director of Kraken Kratom Jenn Ladder revealed that investment interest has spiked and a late industry agreement in New York was surged by venture investors.
Lauder added that he thinks this will open the door for more businesses to enter and that when others see this as an attractive and profitable business venture, this will be enough to push them forward.
Currently, some big pharma corporations are weighing their options to enter the scene. Atai is creating a drug taken from Kratom to alleviate pain and opioid-withdrawal side effects. Atai plans to launch clinical studies by early next year, according to Shrinivas Rao, Chief Scientific Officer of the Company.
According to a late N.Y University study, more than 2M Americans a year use Kratom, with the highest prevalence emerging among opiate users. Co-owner of big retail chain CBD Kratom, Dafna Revah, believes that the WHO panel’s decision could open doors for consumers that were previously skeptical due to the pending evaluation of the drug.
The American Kratom Association claims that development has been restricted by legal uncertainty. In most states, Kratom is available as a dietary or herbal supplement. However, 6 states have outlawed it directly, although no new statewide limitations have emerged from 2016 to this day. Five states have also passed industry-supported acts known as the “Kratom Consumer Protection Act” that features age limitations and quality standards.
Regulatory matters sway off the majority of big corporations. The FDA’s decision to seize imports leads to extensive supply-chain problems since nearly all U.S. Kratom comes from S.E Asian nations like Thailand and Indonesia. In early 2022, around 75K pounds of the substance were seized and destroyed, and an FDA representative said the agency would continue to take action against imports.
The risk though hasn’t discouraged smaller companies from examining the market. LFTD Partners, which mainly focuses on vape and cannabis products, is in negotiations to purchase Kratom companies. Tauriga Sciences Inc is currently developing a Kratom-based gum.
As public approval spikes, Lauder believes Kratom will follow a similar legalization journey to Cannabis, which means that regulations will occur at a state level first and then nationwide. She added that in the past 5 years, we’ve been able to transition from being on the fence to “really going on the offense”.
Figure of the week
8583 is the number of comments added in reaction to WHO notice that called for the discussion of benefits and risks of kratom.
Quote of the week
Nathan R. Dean, a Bloomberg Intelligence analyst, commented in a Dec 14 announcement named “Marijuana Bank Bill Mostly Smoke, Mirrors Without Legalization” that “we continue to note that most banks