One of our key non-generic development products is Oxycodone hydrochloride ER, an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation. Oxycodone hydrochloride ER is designed to discourage common methods of tampering associated with misuse and abuse of prescription opioid analgesics. Oxycodone hydrochloride ER provides deterrence against intentional (drug abuse) and unintentional dose dumping.

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 fibomyalgia. 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). A controlled-release version of pregabalin should reduce the number of doses patients take, potentially improving patient compliance and clinical outcomes.