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Author: Admin | 2025-04-28
This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.OPSYNVI® (macitentan and tadalafil)Medical InformationOPSYNVI® (macitentan and tadalafil)-->OPSYNVI - Single-Tablet Combination Therapy vs Loose Dose Combination-->SUMMARYResearchers involved in the rationale, formulation, and clinical development of OPSYNVI explain that adherence to the prescribed therapy has an impact on clinical outcomes and reducing the pill/tablet count and frequency of consumption has an impact on patient’s adherence to therapies in general and to pulmonary arterial hypertension (PAH) therapies in particular. One way to simplify treatment is to utilize fixed-dose combination (FDC, also known as single-tablet combination therapy [STCT]) products that combine multiple treatments into a single tablet.1-7The A DUE authors proposed that a simplified PAH treatment regimen in the form of a single OPSYNVI tablet containing a FDC of macitentan 10 mg and tadalafil 40 mg given once daily vs loose dose combination of 3 tablets (one macitentan 10 mg and 2 tadalafil 20 mg tablets) would reduce pill burden, thereby, offering a convenient treatment option, and potentially improving treatment adherence in patients with PAH.2Three phase 1 pharmacokinetic (PK) studies established bioequivalence between macitentan 10 mg/tadalafil 40 mg FDC (M/T FDC 10/40) and single-component tablets of macitentan 10 mg and tadalafil 40 mg (coadministered as 3 tablets) in healthy subjects.4,5Another phase 1 PK study established bioequivalence between macitentan 10 mg/tadalafil 20 mg FDC (M/T FDC 10/20) and single-component tablets of macitentan 10 mg and tadalafil 20 mg (coadministered) in healthy subjects.7Results from analyses based on patients’/clinicians’ experience with a STCT of OPSYNVI over loose dose combination therapy of macitentan 10 mg and tadalafil 40 mg have been summarized below.8,9CLINICAL DATAThe A DUE authors proposed that a simplified PAH treatment regimen in the form of a single OPSYNVI tablet containing a FDC of macitentan 10 mg and tadalafil 40 mg given once daily vs loose dose combination of 3 tablets (one macitentan 10 mg and 2 tadalafil 20 mg tablets) would reduce pill burden, thereby, offering a convenient treatment
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