FDA Guidance On Peripheral Neuropathy Drugs In The Works
This article was originally published in The Pink Sheet Daily
The agency is holding a public workshop to discuss therapeutic targets and clinical trial design for disease-modifying agents to treat peripheral neuropathy; many products in recent development have faced challenges.
You may also be interested in...
FDA public workshop will consider the design of clinical studies testing antibacterial drugs to treat lung damage caused by recurrent infections.
One day each will be devoted to eosinophilic esophagitis, pediatric and adult inflammatory bowel disease, and parenteral nutrition-associated liver disease, Sept. 19, 20, 21 and 24, in that order.
One failed study tested Lyrica in a subset of difficult-to-treat patients in the approved indication of diabetic neuropathy, while another explored its use in neuropathic pain related to HIV.