Regabatin: A New Solution Filling a Controlled Release Gap
Our once-a-day Regabatin™ (pregabalin) extended-release capsules are indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury and fibromyalgia. Regabatin™ is based on our controlled release drug delivery technology platform which utilizes the symptomatology and chronobiology of fibromyalgia in a formulation intended to provide a higher exposure of pregabalin during the first 12 hours of dosing. Based on positive feedback and guidance from the FDA, we submitted an IND application for Regabatin™ in August 2015. The FDA completed its review of the IND application and provided constructive input that we will use towards further development of the program.
The brand reference drug is Lyrica® (immediate release pregabalin), and at the current time, there are no FDA approved controlled-release formulations on the market. A controlled-release version of pregabalin should reduce the number of doses patients take, potentially improving patient compliance and clinical outcomes.