• by Les Luchter , Staff Writer, Yesterday

“Now if you're tired or a bit run down,
Can't seem to getcha feet off the ground,
Maybe you oughta try a little bit of L.S.D.”

-       Country Joe and The Fish, “Acid Commercial,” 1967

The above faux ad represents the middle era in LSD’s history, which also happens to be its most-enduring legacy: as a recreational drug that sent members of the hippie generation on weird, dangerous “trips.” 

But, as seen in the visuals accompanying this YouTube video of that Country Joe tune, LSD (an acronym for lysergic acid diethylamide) began its life back in the early 1940s as Delysid, a mental health med from pharma firm Sandoz.

Before Sandoz ended production of the drug in the wake of increasing recreational use (or abuse) in 1965, Sandoz had spent years marketing Delysid to the psychiatric and medical communities for research purposes, much of it through a series of often-creative industry films.

Now, LSD has come full circle, with Definium Therapeutics in phase 3 clinical trials for a couple of LSD iterations -- one for general anxiety and major depression, the other for autism -- and a just-launched awareness campaign called “Rerouting Minds.”

The campaign, consisting of a website, video, social media outreach and PR, is targeted not only to healthcare providers, but to anyone “interested in the “larger conversation around mental health and psychedelics,” Definium Chief Medical Officer Dan Karlin tells Pharma & Health Insider.

“We are forging a new era of psychiatry….” declares the video. “Guided by precision and rigor to unlock the clinical promise of LSD as a transformative therapeutic, we are reshaping the future of mental health with transparency and trust…This is precise science.”

Last month’s launch of “Rerouting Minds” coincided with Definium changing its name from Mind Medicine (or MindMed), by which it had been known during its first six years of existence.

While” MindMed” was fine for an “early stage biotech…in the psychiatric category,” Karlin explains, “Definium” is “more distinctive, recognizable and searchable, and more coherent and consistent with an emerging pharma company.”

Unlike other emerging pharma companies, though, Definium sort of needs to do an image makeover for its product.

When told that “CMO” in these pages normally means “chief marketing officer,” not “chief medical officer,” Karlin noted that “how we see the drug fitting into medicine and psychiatry and potentially even society is very much in my wheelhouse.”

A massive backlash against LSD eventually culminated in a 1970 Congressional law declaring it a Schedule 1 drug, meaning it officially has “no accepted medical use” in the U.S.

So, unlike other pharma firms, Definuium must deal not only with the FDA (Food & Drug Administration), but also with the DEA (Drug Enforcement Administration).

In practice, that should mean that once the FDA approves a Definium drug, LSD will then have an “accepted medical use” and the DEA should take it off of Schedule 1.

“We consider ourselves very fortunate to be able to do this work in a time when regulatory bodies, science as a whole, academic institutions and funding organizations are all coming to the view that perhaps mental health, physical health and the world were not particularly well-served by the this drug being banned from clinical research for so long,” says Karlin.

“This isn't about non-medical or recreational use of the drug,” he continues, but “about bringing forward an old child, a drug that predates our psychopharmacology that we have available today for use in psychiatric and medical settings.”

“LSD has a rich, complex history…We think it’s very important to purposely guide and shape this next iteration.”