Rock Creek Pharmaceuticals, Inc., a drug development company focused on chronic inflammatory disease and neurologic disorders, announced today it has received a written response from the U.S. Food and Drug Administration (FDA) in response to the New Dietary Ingredient Notification (NDIN) for the formulations of Anatabloc® and CigRx® submitted by the Company in June 2014. The letter indicated that the FDA considers anatabine citrate, a principal ingredient in these products, to be a drug, because anatabine citrate is intended to provide anti-inflammatory support, and is the subject of a previously filed Investigational New Drug Application (INDA).
The NDIN submission came in response to a previously issued FDA letter to the Company, which indicated that an NDIN was required before the Company’s supplements could be marketed. In August 2014, the Company voluntarily suspended CigRx and Anatabloc sales, as the Company conducts an internal review and analysis of its supplement business, which is expected to be complete by year end 2014.
Michael Mullan, MBBS, PhD, Chairman and CEO of Rock Creek Pharmaceuticals, remarked, “We are conducting an internal review of our nutritional supplement business and will embark on the course best suited for the Company, its shareholders and customers. Concurrently, we are advancing our lead compound as a drug into human clinical trials.”
As previously disclosed, the Company is pursuing a clinical development program in the United Kingdom under a Clinical Trial Application (CTA) currently anticipated to be filed within the next four months. The Company has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration, which is on clinical hold pending additional data for the Agency to review.