Johnson & Johnson's ketamine-derived medicine is poised to fill a gap in the historical dearth of available therapeutic options for individuals with treatment-resistant depression, building revenue for the healthcare giant in the process.
Esketamine, which will be marketed as Spravato, received the U.S. Food and Drug Administration's approval March 5. The nasal spray is the first new indication for ketamine since the substance — also used as a recreational club drug — was approved in the U.S. for anesthetic purposes in 1970.
Patients with treatment-resistant depression have a seven-fold increase in suicide rate, according to Johnson & Johnson. Approximately one-third of individuals with major depressive disorder are treatment-resistant, meaning they have shown a lack of response to at least two different treatments.
According to Cowen analyst Joshua Jennings, Spravato could become a blockbuster drug for Johnson & Johnson's Janssen Pharmaceuticals Inc. unit. Jennings wrote in a March 6 note that the drug, coming on the heels of the approval of Johnson & Johnson's Tremfya and Erleada, should help cover some of the company's exclusivity losses of about $3 billion from generic and biosimilar competition.
Jennings posited that Janssen, which developed Spravato, should see at least 5% revenue growth in 2020 and thereafter.
Moody's Senior Vice President Michael Levesque seconded Jennings' outlook, deeming the approval "credit positive" with potential to offset generic and biosimilar erosion.
In an attempt to address safety concerns, Spravato, which would be taken in combination with an oral antidepressant, includes a boxed warning highlighting esketamine's known side effects, such as dissociation, sedation, and abuse and misuse. The nasal spray will only be taken in an authorized healthcare setting under the supervision of a certified healthcare professional. The patient would be monitored for at least two hours post-treatment and would need to sign a form acknowledging arrangement for safe departure from the facility.
The risk evaluation and mitigation strategy mirrors suggestions put forth during the FDA's advisory committee meeting on Spravato, which raised concerns about patients driving post-treatment.
New Brunswick, N.J.-based Johnson & Johnson said in a March 5 press release that work to educate and certify treatment centers is already underway.
Prior to Spravato's approval, "ketamine clinics" had cropped up across the U.S., administering off-label intravenous treatments for treatment-resistant depression patients and signaling an unmet need. Only one FDA-approved pharmacologic option, a combination of generic fluoxetine and olanzapine, has been available for this type of depression. Other options were device-related, including electroconvulsive therapy, which carries a risk of procedure complications and significant adverse events.
One ketamine clinic operator in Denver, Roman Langston, told S&P Global Market Intelligence in November 2018 that the approval of esketamine would provide more supportive data for the substance's effects in mood disorders. However, Langston noted that ketamine clinics may see a decline in patients as they gravitate towards an FDA-approved therapy with likely insurance coverage.
Janssen is also testing Spravato in phase 3 trials for major depressive disorder patients with imminent risk of suicide. The company is also expecting approval for treatment-resistant depression from the European Medicines Agency later in 2019.