Development Status & Regulatory Process

The use of dronabinol for the treatment of OSA is a novel indication for an already approved drug and, as such, ResolutionRx believes that it would allow us or a development partner to submit a 505(b)(2) NDA to the U.S. FDA for approval of a new dronabinol label, as opposed to the submission and approval of a full 505(b)(1) NDA.

 

In the United States, the 505(b)(2) NDA was created by the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act to help avoid unnecessary duplication of studies already performed on a previously approved drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant, and allows for data developed by others. A 505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval, such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant. This can result in a less expensive and faster route to approval, compared with a traditional development path, such as 505(b)(1), while still allowing for the creation of new, differentiated products. This regulatory path offers market protections under the Hatch-Waxman Act, as amended, and the rules promulgated thereunder, providing for market exclusivity.

 

Other regulatory routes are available to pursue proprietary formulations of dronabinol that will provide further market protections. In Europe, a regulatory approval route similar to the 505(b)(2) pathway is the hybrid procedure based on Article 10 of Directive 2001/83/EC.