China-based 3SBio Inc. (HKG: 1530) has announced receiving marketing approval from the National Medical Products Administration (NMPA) in China for its nalfurafine orally disintegrating tablets. The drug is used to improve pruritus in hemodialysis patients in situations where existing treatment efficacy is not ideal. This marks the first and only selective opioids κ receptor agonist for this indication in China.
Nalfurafine’s Clinical Approval and Impact
The drug was previously approved for clinical study in improving pruritus in chronic liver disease, also in situations where existing treatment efficacy is not ideal, in May this year. Nalfurafine, which has been approved to improve pruritus in hemodialysis patients and patients with chronic liver disease and peritoneal dialysis in Japan, has demonstrated significant therapeutic effects on hemodialysis pruritus resistant to current treatments in clinical trials conducted in Japan.
Oral Disintegrating Tablet Form and Patient Compliance
The orally disintegrating tablet dosage form of nalfurafine was approved for sale in Japan in 2017, enhancing the convenience and compliance of medication for patients with impaired swallowing function or those with limited water intake. This dosage form provides an alternative for patients who may have difficulty with traditional oral medications.
Exclusive Rights and Commercialization in China
3SBio struck a licensing deal with Toray Industries, Inc. in December 2017, obtaining exclusive development and commercialization rights to the preparation in China mainland. This partnership underscores 3SBio’s commitment to bringing innovative treatments to patients in need within the region.-Fineline Info & Tech
