Sycrest Organon N.V. · Authorised · authorised 1 Sep 2010 · ATC N05AH05
Therapeutic indication (EMA)
Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.
Active substance
Asenapine
- US FDA 5
- EMA 1
- Health Canada 2
- US price lines 9
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SAPHRIS | EQ 5MG BASE; EQ 10MG BASE; EQ 2.5MG BASE | tablet · sublingual | ABBVIE | Prescription | 13 Aug 2009 |
| SECUADO | 3.8MG/24HR; 5.7MG/24HR; 7.6MG/24HR | system · transdermal | HISAMITSU | Prescription | 11 Oct 2019 |
| ASENAPINE MALEATE | EQ 2.5MG BASE; EQ 10MG BASE; EQ 5MG BASE | tablet · sublingual | BRECKENRIDGE | Prescription | 10 Dec 2020 |
| ASENAPINE MALEATE | EQ 5MG BASE; EQ 10MG BASE; EQ 2.5MG BASE | tablet · sublingual | ALEMBIC | Prescription | 10 Dec 2020 |
| ASENAPINE MALEATE | EQ 5MG BASE; EQ 10MG BASE | tablet · sublingual | SIGMAPHARM LABS LLC | Prescription | 10 Dec 2020 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ASENAPINE 10 MG TABLET SL | $2.62719 | per EA | 23 Sep 2026 |
| US NADAC | ASENAPINE 2.5 MG TABLET SL | $3.08807 | per EA | 23 Sep 2026 |
| US NADAC | ASENAPINE 5 MG TABLET SL | $2.03247 | per EA | 23 Sep 2026 |
| US NADAC | SAPHRIS 10 MG TAB SUBLINGUAL | $21.15928 | per EA | 23 Sep 2026 |
| US NADAC | SAPHRIS 2.5 MG TAB SUBLINGUAL | $20.99436 | per EA | 23 Sep 2026 |
| US NADAC | SAPHRIS 5 MG TAB SUBLINGUAL | $21.16056 | per EA | 23 Sep 2026 |
| US NADAC | SECUADO 3.8 MG/24 HR PATCH | $49.0677 | per EA | 23 Sep 2026 |
| US NADAC | SECUADO 5.7 MG/24 HR PATCH | $49.04924 | per EA | 23 Sep 2026 |
| US NADAC | SECUADO 7.6 MG/24 HR PATCH | $48.83104 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 22 Jan 2025 SAPHRIS — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Jan 2025 SECUADO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions - EMA PRAC 11 Jun 2015 PRAC signal: Acute renal failure
Action for MAH: update of the product information: No - EMA PRAC 6 Nov 2014 PRAC signal: Acute renal failure
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.