Ketamine-Like Depression Drug Isn’t a Surefire Hit

(Bloomberg Opinion) -- The Food and Drug Administration’s approval Tuesday evening of Johnson & Johnson’s depression drug Spravato, a nasal spray that is a close cousin to the anaesthetic and party drug ketamine, is a big deal for patients. 

The depression medicines available now aren’t always effective and can take weeks to have an impact even when they are. Spravato is the first fast-acting medicine of its kind and works in an entirely different way than current options. The new drug could help people with severe depression and those who don’t respond to conventional treatment. It’s not a silver bullet: The spray has produced mixed data and has significant side effects and abuse potential, which has led to FDA restrictions on its use. Even so, it addresses a large unmet need and has life-changing potential

Ketamine-Like Depression Drug Isn’t a Surefire Hit

Investors can thank FDA chief Scott Gottlieb for Spravato’s approval even as they mourn his departure, announced a few hours earlier. His FDA has been quick to get drugs to market — Spravato’s approval came six months after J&J submitted it, a period that included the government shutdown — and the agency has been willing to give drugmakers the benefit of the doubt. 

That was needed here. Spravato’s clinical data is compelling but not pristine. It didn’t succeed in two of the five late-stage studies J&J ran, which has led some to question whether there’s enough evidence to justify approval. But under Gottlieb, there’s been wiggle room when patients don’t have good options. The agency saw enough positive data and patient need to quickly approve the medicine without more restrictions than investors expected.

So now that it’s approved, what kind of market is there for Spravato? That’s a trickier question. 

The treatment can only be administered under supervision in a certified provider’s office. Patients will have to be monitored for at least two hours after taking the drug for side effects like dissociation, and aren’t supposed to operate heavy machinery for the rest of the day. Your average psychiatrist may not be set up for that, and it’s difficult for patients to regularly spend that long in an office and find rides home. That is likely to significantly slow uptake. Providers also might want to see more evidence — J&J is currently running a late-stage trial in suicidal patients — before they embrace the product. 

A strong launch is important for J&J and the commercial future of the drug; it will help patients and providers get more familiar and comfortable with a new approach to depression. An early foothold also would help protect the medicine against competition. 

Sage Therapeutics Inc. and Allergan PLC are working on rival fast-acting medicines that they hope will prove superior. Those drugs are some distance from approval, and investors are still waiting on late-stage data. But the likely slow ramp-up of Spravato will give them ample time to catch up. 

Tens of millions of people suffer from depression, and some of them need quicker or different help. That gives Spravato a chance at commercial success. But large-scale sales or any kind of surety that they’ll be achieved are a long way away. Spravato is a big deal, but may never be a blockbuster.

This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.

Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.

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