OREANDA-NEWS. Chromocell Corporation and Astellas Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the development program of the drug candidate CC8464/ASP1807, for the management of neuropathic pain associated with idiopathic small fiber neuropathy (iSFN).  In 2015, Chromocell and Astellas entered into a license and collaboration agreement for the development and commercialization of CC8464/ASP1807 for the management of neuropathic and other pain indications.

Chromocell submitted the IND for CC8464/ASP1807 in July, 2016, and recently dosed the first subject in a Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of the oral formulation of CC8464/ ASP1807.

The FDA’s Fast Track program is intended to help ensure that therapies intended for serious or life threatening conditions that address unmet medical needs are approved and available to patients as soon as it can be concluded that the therapies’ benefits justify their risks. Features of Fast Track designation include actions that expedite development and review including frequent interactions with the FDA Division responsible for review.

Christian Kopfli, Chief Executive Officer of Chromocell, said, “This is an important milestone for the CC8464/ASP1807 program, following the FDA’s recent acceptance of Chromocell’s investigational new drug (IND) application. Collaboration with the regulatory agency through programs like Fast Track provides further momentum as we advance our lead analgesic drug candidate into clinical trials. It is also a testimony to the close and productive alliance with Astellas. We hope that this development will help us bring a new potential treatment alternative to opioids for patients suffering from peripheral neuropathic pain associated with iSFN as quickly as possible.”

Bernhardt G. Zeiher, M.D., President, Development, Astellas said, “We are pleased that Fast Track designation was granted by the FDA as it recognizes the importance of accelerating the development in the neuroscience area. This is a testament to our commitment to closely collaborate with Chromocell in addressing this unmet medical need.”