American Society of Clinical Psychopharmacology Annual Meeting

American Society of Clinical Psychopharmacology Annual Meeting

Source:

Starr HL, et al. Poster 16. Presented at: American Society of Clinical Psychopharmacology Annual Meeting; May 29-30, 2020 (virtual meeting).

Disclosures: The poster authors report being employees of Janssen.
June 04, 2020
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Data outline real-world early use of esketamine nasal spray for treatment-resistant depression

Source:

Starr HL, et al. Poster 16. Presented at: American Society of Clinical Psychopharmacology Annual Meeting; May 29-30, 2020 (virtual meeting).

Disclosures: The poster authors report being employees of Janssen.
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Data presented at the American Society of Clinical Psychopharmacology Annual Meeting showed prescribing practices and outcomes related to esketamine nasal spray.

“Esketamine is available to patients through a [Risk Evaluation and Mitigation Strategy, or REMS] program,” H. Lynn Starr, MD, director of clinical development at Janssen Scientific Affairs, told Healio Psychiatry. “The data highlighted in this poster examined the characteristics of patients, health care settings, pharmacies and key safety parameters related to esketamine use in the real world. The results of this analysis confirm that the overall safety profile of esketamine and serious adverse events reported in the REMS in the early months after approval were consistent with those observed in the esketamine phase 3 clinical studies.”

infographic with author H. Lynn Starr

The FDA has approved esketamine (Spravato, Janssen) — the S-enantiomer of ketamine racemate and an N-methyl-d-aspartate receptor antagonist — as a nasal spray for patients with treatment-resistant depression. Janssen and the FDA created the REMS to mitigate the risk for serious adverse outcomes associated with sedation and dissociation, as well as from misuse and abuse. Pharmacies and health care settings must meet specific REMS requirements, such as patient monitoring by a health care provider for at least 2 hours after administration, in order to be REMS-certified, dispense esketamine nasal spray and treat patients with it. Further, a prescriber from a certified health care setting must enroll patients in the REMS.

Starr and colleagues aimed to examine and evaluate characteristics of patients, pharmacies, health care settings and key safety parameters associated with esketamine nasal spray use in the first 4 months followings its approval in the U.S. Specifically, they evaluated REMS patient enrollment and patient monitoring forms to obtain patient demographic and initial safety data. They used REMS health care setting and pharmacy enrollment forms to describe the characteristics of esketamine nasal spray prescribing and dispensing settings.

Results showed 1,998 health care settings were certified in the REMS during the initial reporting period. Independent/private practice settings accounted for 40.3%, outpatient clinics for 35.6% and group practices for 25.7%. Most (93.4%) prescribers associated with the certified health care settings specialized in psychiatry and were credentialed as medical doctors (80.1%).

During the reporting period, 1,179 pharmacies received certification. Of these, 37.8% self-identified as outpatient pharmacies, 37.4% as long-term care facilities and 33.8% as mental health facilities. Further, 594 patients had received at least one esketamine nasal spray treatment. Of these patients, 57.9% were female, and the mean age was 47.5 years.

One or more adverse events occurred among 2,148 (57.1%) of 3,760 total treatment sessions. Most patients (80.6%) experienced at least one REMS-specific event of interest —sedation, dissociation or increase in blood pressure — during one or more treatment sessions. According to responses captured at each treatment session, sedation occurred among 63% of patients, dissociation among 61.3% and increased blood pressure among 7.7%, with serious adverse events reported among 4.9% of patients.

“The data enhance our understanding of the types of health care professionals and treatment settings that quickly implemented REMS certification, allowing them to offer treatment with esketamine within the first few months of FDA approval,” Starr told Healio Psychiatry. “That understanding will aid our ongoing education efforts for providers as we work to continue to help ensure the safe and appropriate use of esketamine across the country. In addition, we believe this research will help educate providers who are considering esketamine for their practice.”