Neurodawn Pharmaceutical Co., Ltd.

Neurodawn Pharmaceutical Co., Ltd. (“Neurodawn”) is a clinical demand-driven, registration-stage biopharmaceutical company, dedicated to discovering and developing innovative therapies for CNS diseases, with the aim of providing safe, effective and accessible treatment options to patients worldwide. 
Y-4 is a novel fixed-dose combination drug product with tablet formulation containing two active ingredients of pregabalin and riluzole. Pregabalin and riluzole can inhibit pain-induced neuronal excitability at different levels, and such synergistic action is expected to exert significant analgesic effects in the treatment of chronic neuropathic pain including postherpetic neuralgia, neuropathic pain associated with diabetic peripheral neuropathy, fibromyalgia, and neuropathic pain associated with spinal cord injury.
Our clinical trial programs are the primary way to get access to one of Neurodawn’s investigational medicines. You can find additional information about Neurodawn’s ongoing clinical trials by accessing https://clinicaltrials.gov. Neurodawn recognizes that there may be interest among certain patients in accessing Y-4 tablets outside of clinical trials and prior to obtaining regulatory approval. However, at this time, Neurodawn does not offer expanded access (also referred to as compassionate use) to Y-4 tablets outside of approved clinical trials. This decision is based on considerations including the early stage of development of Y-4, limited clinical safety and efficacy data, and the need to prioritize the conduct of controlled clinical trials to adequately evaluate its safety and effectiveness. 
Neurodawn may reevaluate this policy as development progresses and additional data become available.
Physicians with questions regarding this policy may contact:
Email: huyang@neurodawn.cn