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Safety Studies for 505(b)(2) Applications

The 505(b)(2) pathway is very often cost efficient and lower risk because the NDA application can reference existing preclinical and even human safety studies for the active ingredient. Most often, the excipients used are GRAS-listed. Thus, the applicant doesn’t have to conduct much additional preclinical or safety studies except where needed, such as, to support a new route of administration.

However, there are cases where the development goal is a new indication in a new patient population. Data obtained in one patient population may not be applicable to another population.

For example, Spherix has been developing a new treatment for diabetes using D-tagatose. D-tagatose, a natural product, is marketed (by a subsidiary of Spherix) as a sweetener for food and beverages under the brand name Naturlose. The product is GRAS — as a sweetener. Spherix has been developing this active as a drug to treat type 2 diabetes. The product recently completed
Phase III testing (this and the phase II study (outline), were conducted in the US and India). But the company has reached the end of its budgetary road. In this patient population, cardiovascular risks must be evaluated and these trials take years and millions of dollars. Thus, Spherix is looking for a deep-pocketed partner.