The most useful reference point for what a psychedelic approval looks like in practice is not an academic paper or an industry conference panel. It is Johnson & Johnson’s quarterly earnings releases for Spravato over the past seven years. Esketamine, the nasal-spray formulation of the NMDA antagonist ketamine, was approved by the FDA on March 5, 2019 for treatment-resistant depression. It became the first centrally acting, dissociation-producing drug approved for a psychiatric indication in the modern regulatory era. Its commercial trajectory is the closest analog to what the field can expect when a classical psychedelic approval arrives.

The Spravato story has been told in fragments in industry press, but it has not been pulled together as a reference for the next launch. This piece does that. The launch is more instructive than the approval, and the launch is now seven years deep with public revenue data, public REMS-certification numbers, and a public payer-coverage history.

The approval and the regulatory framework

Spravato received FDA approval in March 2019 under a combination of designations: Breakthrough Therapy, Priority Review, and approval as a Schedule III controlled substance. The approval included a Risk Evaluation and Mitigation Strategy (REMS) that established the framework every centrally acting psychiatric compound has operated under since.

The REMS requirements are specific. Spravato can only be administered in REMS-certified healthcare settings. Patients must be observed by a healthcare provider for at least two hours after each dose. The drug cannot be dispensed for at-home use. Each treatment session is reported to the central REMS database. Certified settings must designate an Authorized Representative responsible for compliance.

The standard treatment course is intensive. The initial induction phase typically runs four weeks at two sessions per week, declining to weekly sessions, then biweekly or less frequent maintenance. Each session is in-clinic, two-hour-observation, requires a designated driver, and is reimbursed through a combination of drug-product billing and the in-clinic supervision codes.

This framework was constructed deliberately and has worked as designed. The Spravato REMS has documented no major safety incidents requiring program modification since launch. The framework is now the operational template for any subsequent centrally acting psychiatric approval. The FDA’s draft guidance on psychedelic clinical trials specifically references the Spravato REMS as an example of acceptable safety architecture for compounds with similar pharmacological profiles.

The launch trajectory

Spravato’s launch was, by pharmaceutical standards, slow. The drug entered a market that did not have payer infrastructure for in-clinic psychiatric drug administration, prescriber infrastructure for the REMS-certified treatment center model, or patient awareness of the treatment category. The first year of sales was modest. The second year was modest. The category had to be built before the product could grow.

The quarterly revenue numbers tell the story. By 2023, full-year Spravato revenue was approximately $689 million worldwide. In 2024, full-year revenue grew to over $1 billion. In the third quarter of 2025 alone, Spravato generated $1.19 billion worldwide ($1.05 billion U.S., $146 million international), representing 53 percent year-over-year growth.

The product took roughly six years to cross the $1 billion annual revenue threshold. It is now growing at a 50-percent-plus annual rate from that base. Johnson & Johnson identifies Spravato as one of the company’s fastest-growing neuroscience products in current earnings commentary.

The six-year ramp is the operationally important number. Spravato had every commercial advantage a launch can have: a major pharma sponsor with infrastructure (Janssen, now Johnson & Johnson Innovative Medicine), a clear unmet-need positioning (treatment-resistant depression has no shortage of patients), broad payer coverage commitments in principle, and a Breakthrough Therapy designation that supported launch-readiness work during development. Even with all of that, the first three years of sales were modest, and the inflection happened in years four through six.

The reasons matter for any company planning the next psychedelic launch.

What the slow ramp actually reflects

Three factors explain the trajectory.

The first is provider infrastructure. The REMS-certified treatment center model requires either an existing psychiatric practice to retrofit its facility (a real capital investment plus operational training), or new facilities to be built specifically for the model. Johnson & Johnson committed substantial resources to expanding the REMS-certified network. The build-out took years.

By 2024, the number of REMS-certified treatment centers in the U.S. had grown to approximately 5,000. As of late 2025, the network covers roughly 7,000 outpatient settings plus a smaller number of inpatient certifications. The growth curve approximately parallels the revenue growth curve, which is what would be expected if provider capacity is the binding constraint.

The second is payer adoption. Commercial insurance plans, Medicare, and Medicaid all had to develop specific coverage and prior authorization frameworks for the in-clinic drug administration model. This process took years and varied substantially by payer. Early adopter payers had Spravato coverage by 2020-2021; some payers did not have settled coverage until 2023-2024. Even now, prior authorization requirements vary widely, and some patients face substantial step-therapy requirements (typically requiring failure of multiple prior antidepressants before Spravato is authorized).

The third is patient and prescriber awareness. The treatment-resistant depression patient population is approximately 2-3 million U.S. adults. Most of them did not know Spravato existed in 2020-2021. Outreach to psychiatrists, the patient education infrastructure, the referral pipelines from general psychiatry to Spravato-administering specialists: all of this had to be built. The 2024-2026 acceleration partly reflects the maturation of this educational and referral infrastructure.

Each of these three constraints will apply, in approximately the same form, to any classical psychedelic that reaches FDA approval. Compass’s COMP360 will need REMS-certified treatment centers (the architecture will likely be modeled on Spravato’s). Compass will need payer-coverage policies built. Compass will need the awareness and referral infrastructure that Spravato spent six years building. The infrastructure Spravato has built will help, but COMP360 is a different drug under a different REMS, and substantial adaptation will be required.

What the Spravato data tells us about COMP360

Three specific predictions follow from the Spravato launch curve, assuming COMP360 approval arrives on the accelerated timeline the voucher program creates.

First: the first 12 to 18 months of COMP360 sales will likely be modest by industry standards. Even with the voucher-compressed review window and the head start that Spravato’s existing infrastructure provides, COMP360 will face its own REMS build-out, its own payer-adoption cycle, and its own awareness-building requirement. A launch revenue trajectory of $50-150 million in year one would be consistent with Spravato’s precedent. Analyst projections that assume rapid initial uptake should be checked against the Spravato comparable.

Second: the eventual revenue ceiling for COMP360 is meaningfully larger than the initial launch trajectory suggests. Spravato’s six-year ramp to $1 billion is now producing 50-percent-plus annual growth from a $4 billion-plus run-rate. If COMP360 achieves similar maturation, the product is plausibly worth substantially more than its Phase 3-stage market valuation suggested at any point in the program’s history. The investment case for COMP360 should be a 5-to-7-year ramp, not a 1-to-2-year ramp.

Third: the structural margin advantages of being the first classical psychedelic approved are real but bounded. Spravato has spent six years building infrastructure that COMP360 can partially leverage. But the second-mover advantage runs in both directions: subsequent psychedelic approvals (Otsuka/Transcend’s TSND-201, Usona’s PSIL201, AtaiBeckley’s BPL-003 if it reaches approval) will also leverage the same infrastructure. Compass’s first-mover advantage is real but probably less durable than it would be in a different drug class.

The broader implications

For investors evaluating the psychedelic sector after the voucher decisions, the Spravato comparable suggests several things.

The voucher’s compressed review window matters less for commercial outcome than the launch infrastructure does. A drug approved in 12 months on the voucher path will have the same launch trajectory as a drug approved in 18 months on the standard path, all else equal. The voucher is real, but its commercial value is smaller than the headline coverage suggests.

Pharma incumbents with existing interventional psychiatry infrastructure (Johnson & Johnson on Spravato) have structural advantages over pure-play psychedelic developers (Compass, AtaiBeckley) for any commercial launch in the interventional psychiatry model. Otsuka’s acquisition of Transcend, in this framing, makes Otsuka’s TSND-201 launch much more credible than it would have been under Transcend alone, even though TSND-201 is the less mature program. The same logic suggests that Compass’s eventual launch may benefit more from a commercial partnership with an established pharma operator than the company has so far signaled it is pursuing.

The interventional psychiatry model itself is a structural innovation in U.S. pharmaceutical commercialization, not just for psychedelics but for any compound whose administration requires in-clinic supervision. The infrastructure being built for Spravato, COMP360, TSND-201 and others will outlast any individual product. The companies that own positions in that infrastructure (REMS-certified networks, payer agreements, prescriber relationships) may end up with more durable value than the companies that own positions in any individual molecule.

The closest precedent we have for the next psychedelic launch is the launch that already happened. The lessons are not the ones the field’s optimistic press tends to draw. The lessons are about patience, infrastructure, and the slow compounding work of building a category. Spravato got to $1 billion in revenue, eventually. It took six years. The next launch will probably take comparably long. Sponsors and investors who price that reality in are positioned correctly. Those who do not will likely be surprised, twice: by how slow the first three years feel, and by how durable the eventual revenue is.