China-based 3SBio Inc. (HKG: 1530) has announced that a clinical trial filing for its nalfurafine oral disintegrating tablets (TRK-820) for the improvement of pruritus in patients with chronic liver disease has been accepted for review by the National Medical Products Administration (NMPA). This follows the previous acceptance for review of the market filing for the drug to improve pruritus in hemodialysis patients with unsatisfactory therapeutic effects.
Chronic Liver Disease and Pruritus
Patients with chronic liver disease often suffer from strong systemic itching, and some patients are treated with antihistamines, antiallergic drugs, anion exchange resins, and other drugs without any effect. Nalfurafine, an opioids κ Receptor agonist developed by Japan-based Toray Industries, Inc., was approved in 2009 in Japan to improve pruritus in hemodialysis patients (only limited to the situation where the current treatment effect is not ideal), followed by the indication approval of improving pruritus in patients with chronic liver disease and peritoneal dialysis (only if the current treatment effect is not ideal).
Nalfurafine’s Market Approval and 3SBio’s Licensing Deal
The orally disintegrating tablets dosage form obtained a marketing nod in Japan in 2017, for use in patients with impaired swallowing function or patients with limited water consumption. 3SBio struck a licensing deal with Toray in December 2017, obtaining development and commercialization rights to the product in the Chinese mainland.
Strategic Implications
The acceptance of the clinical trial filing for nalfurafine oral disintegrating tablets by the NMPA represents a significant step forward for 3SBio in expanding its product offerings in the treatment of pruritus associated with chronic liver disease. This move is expected to enhance the company’s position in the market and provide new treatment options for patients suffering from this debilitating condition.-Fineline Info & Tech
