China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that the National Medical Products Administration (NMPA) has accepted for review a market approval filing for its drug candidate HSK16149 as a treatment for post-herpes neuralgia (PHN). This in-house Category 1 drug, an oral gamma-aminobutyric acid (GABA) analogue, is under development for the treatment of peripheral neuropathic pain. A market approval filing for HSK16149 as a treatment for diabetic peripheral neuropathic pain (DPNP) was previously accepted for review in China in October 2022.
Preclinical and Clinical Trial Results Support HSK16149’s Efficacy and Safety
Preclinical studies have demonstrated that HSK16149 can provide long-term analgesia with minimal central side effects, making it a promising candidate for pain management. The statistical results from the confirmatory clinical trial for PHN indicate that HSK16149 has statistically reached the primary efficacy endpoint. Safety statistics further show that the overall safety profile of HSK16149 is positive and manageable.
HSK16149’s Administration and Potential Advantages
The administration process of HSK16149 does not require titration, which simplifies its use in clinical settings. Haisco Pharmaceutical Group believes that HSK16149’s better safety and effectiveness could position it as the preferred medication for peripheral neuropathic pain, offering a new option for patients suffering from conditions like PHN and DPNP.-Fineline Info & Tech
