Novan announced after FDA meeting the decision to conduct one additional phase III trial for SB 206 as a treatment for molluscum contagiosum.

Novan, Inc. announced that the Company has conducted its Type C meeting with the FDA regarding SB 206 for the treatment of molluscum. The purpose of the meeting was to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB 206 to support a future New Drug Application (“NDA”).

Based on guidance received during the meeting, the Company understands the FDA will consider one additional pivotal trial (“B-SIMPLE4”), if successful, to be supported by the previously completed B-SIMPLE2 trial. In addition, the FDA provided guidance with regard to both the study design for B-SIMPLE4 and expectations for a future NDA submission. FDA-generated minutes, expected on or before May 1, 2020, will serve as the meeting’s official record.

Novan’s Japanese development and commercialization partner, Sato Pharmaceutical Co., Ltd. has also informed the Company of Sato’s intention to progress the SB 206 development program in Japan with a Phase 1 clinical trial given the observed treatment benefit and favorable safety profile in the B-SIMPLE program.

Comment: Ycanth (canthandin 1%) from Verrica Pharma was filed at the FDA in September 2019 for Molluscum based on CAMP 1 and CAMP 2 trials and has a PDUFA date of 13 July 2020.