What are the costs of synthesising Schedule I drugs?

Since the 1970s, psychedelic drugs have been classified as Schedule I substances – the most restrictive category. Substances in this category are believed to be devoid of any medical value, but thanks to the work of researchers around the globe, we now have the evidence that says otherwise.

Despite the resurgence in psychedelic research in recent years – psychedelics are notoriously difficult and expensive to work with.

Manufacturers and researchers alike must comply with the high regulatory standards that accompany Schedule I substances.

While some of these standards are necessary – if psychedelics are going to be widely accessible medicines, where will they come from, and how are they going to be affordable?

The price of working with some psychedelics

Researchers have reportedly been paying in excess of $7,000 per gram of psilocybin. While this psilocybin is likely of the highest quality, and it would take a significant amount of dried mushrooms to yield this amount of pure psilocybin – the cost greatly exceeds the current street value of $10 per gram of dried mushrooms.

Similarly, the street value of MDMA is roughly $5-$10 per tablet (at least 1 full therapeutic dose), making its current price for research purposes very costly in comparison.

Before beginning their Phase III trials using MDMA to treat PTSD, MAPS had to find a company to manufacture the MDMA – and it didn’t come cheap. When they finally settled on a company, it cost roughly $400,000 to produce 1kg of the drug.

While one kilo can yield thousands of doses, if companies are looking to turn a profit, how will these high manufacturing costs be reflected at the patient level?

Why are the costs so high?

One of the reasons stems from manufacturers complying with current Good Manufacturing Practices (cGMP). While cGMP ensures the highest quality product – it doesn’t come cheap.

Not only do the substances themselves have to meet high regulatory standards – so too do the equipment and even the people working with these substances. Together, the high costs associated with clinical research and Schedule I substances boil down to the paperwork that accompanies working with controlled substances.

With so many rules and regulations surrounding controlled substances – there is little commercial incentive for companies to manufacture them and, therefore, keeps the prices high.

The tide is turning as more manufacturing companies enter the space, which spurs competition and will hopefully drive prices down. But, for prices to truly fall – we must look toward rescheduling these drugs.

If you’re interested in topics like this and more and want to hear what leaders in the field have to say – join us for ICPR 2022 Psychedelic Science, Ethics & Business, taking place this September in The Netherlands.

Get your tickets here.

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