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Lorcaserin becomes first psychedelic approved for medical use in US

Source : http://www.psychedelicfrontier.com/2013/05/09/lorcaserin-becomes-first-psychedelic-approved-for-medical-use-in-us/

This is a landmark step towards sensible US drug policy. Since the Nixon Administration passed the Controlled Substance Act passed in 1970, all psychedelics have been classified as Schedule I, which means absolute prohibition with no recognized medical potential. Lorcaserin, a weight loss drug which has psychedelic effects at high doses, has just been classified as a Schedule IV medicine. This marks the first time that the DEA has acknowledged the medical benefits of a psychedelic. Doctors can now prescribe this drug for the “off-label” use in psychedelic therapy. Amazingly, no media outlets are reporting this historic decision.

Lorcaserin is a weight loss drug, the first one to be approved since 1999. Its placement in Schedule IV indicates a “low potential for abuse and low risk of dependence.” Other drugs in Schedule IV include benzodiazepines such as Xanax, Valium, and Ambien.

Like other psychedelics, lorcaserin is an agonist at serotonin receptors, particularly 5-HT2C and 5-HT2A. That’s not to say patients looking to lose weight will be tripping balls, since psychedelic effects only kick in at higher doses. Nor is there likely to be much demand for lorcaserin among recreational users (there are better options with plenty of availability). The importance of this decision is more symbolic.

A new precedent has been set in American drug policy. We are finally breaking free from the traditional rhetoric of “all psychedelics are poisons” and taking an evidence-based approach to drug policy. Imagine, evaluating drugs based on their effects and safety profile rather than political pressure! Let’s hope this decision is just the beginning of a new, ongoing commitment to rational drug policy. This hope isn’t as far-fetched as you might think, considering that psychedelic advocate Rick Doblin recently met with the Pentagon to discuss the study of MDMA in treating veterans with PTSD.

An important result of this decision is that doctors can now prescribe lorcaserin for off-label purposes such as psychedelic therapy. (Off-label: The FDA approves and denies drugs for clinical use, but it does not have the legal authority to regulate the practice of the medicine. Doctors commonly prescribe drugs off-label, meaning for purposes which have not been specifically approved by the FDA.)

The only drug in an arguably similar position is ketamine, a Schedule III dissociative anesthetic which has shown potential in treating depression and is slowly becoming clinically available for that purpose. Lorcaserin is completely different from ketamine in chemistry and effects, and may offer a variety of unique therapeutic applications. Therefore it is the first psychedelic agent available for psychotherapy in the United States. If its effects are similar to LSD or psilocybin (and they may not be, especially considering lorcaserin’s much higher affinity for 5-HT2C over 5-HT2A receptors) then this opens a brand new avenue in medicine. Or more accurately, it is one step towards legitimizing an existing discipline which has remained illegal and underground for decades: psychedelic therapy.

This is all speculative, of course. We don’t have enough information about the psychedelic state it produces to conclude that it is useful for therapeutic practice. It may be that a dose high enough to produce useful psychedelic effects also produces unpleasant side effects, rendering it useless for the purpose of psychedelic therapy (not to mention recreational tripping). This statement from a JPET study abstract leads to think this may be the case:

Behavioral observations indicated that unlike the 5-HT2Aagonist (±)-1-(2,5-dimethoxy-4-phenyl)-2-aminopropane, lorcaserin did not induce behavioral changes indicative of functional 5-HT2A agonist activity. [The classic psychedelics tend to have high affinity for 5-HT2A.]

Nevertheless this is a historic decision that represents a step forward in intelligent drug policy.

The DEA summary of the decision is here.

Lorcaserin ((R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzepine hydrochloride hemihydrate) is a new chemical entity which has central nervous system hallucinogenic properties. Lorcaserin is a serotonin receptor agonist, at the 5HT2C and 5HT2A receptor subtypes. Lorcaserin HCl was approved by the Food and Drug Administration (FDA) on June 27, 2012, as an addition to a reduced-calorie diet and exercise, for chronic weight management and it will be marketed under the trade name BELVIQ(r).

For the FDA’s clinical review of lorcaserin, see this document (120 pages).

Here are some results from the study:

  • Lorcaserin 20-60 mg produced a relatively high incidence of dose-related euphoria (6-19%) compared to placebo (0%)
  • The incidence of euphoria from lorcaserin was similar to that reported for zolpidem (13-16%) and less than that reported for ketamine (50%)
  • AEs of euphoria, hallucinations, and dissociation variably seen with lorcaserin in Phase 1 studies
  • Euphoria seen infrequently in Phase 3 [a study of 10mg taken twice daily], yet at greater frequency with lorcaserin than placebo

Note: “AEs” are Adverse Effects like euphoria and hallucinations, better known in the psychedelic community as “desirable effects.”

The single dose studies indicated that nothing much happened in terms of mood shift below 40mg. But with a single 40mg dose, most users report euphoria and “altered mood.” Lower doses were more effective when taken daily. 15mg daily was enough for many participants to report euphoric effects, and at 40mg daily most participants report “altered mood” as well.

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