SUDA Receives Positive Response From FDA Regarding SUD-001 Development Plan

6th August 2015, Perth Australia, ASX Announcement

SUDA LTD (ASX: SUD), a leader in oro-mucosal drug delivery, is pleased to announce that it has received a written response from the US FDA regarding the development plan for the Company’s SUD-001 sumatriptan oral spray for the treatment of migraine.

SUDA submitted a Type C meeting briefing package to the FDA on 13 June 2015 containing details of the proposed pivotal study of SUD-001 and other activities intended to support a New Drug Application in the USA. SUDA’s FDA briefing package was accompanied by a series of questions relating to the development plan.

The FDA acknowledged SUDA’s proposed development strategy and requested only minor justifications to the study design. Furthermore, the agency had no comments regarding SUDA’s plans for chemistry, manufacturing, controls and non-clinical studies of SUD-001. The FDA also requested that SUDA submit a paediatric study plan in migraineurs aged 6-17 years who could benefit from SUDA’s first-in-class oral-spray migraine therapy.

SUDA designed the proposed pivotal trial of SUD-001 with its Clinical Advisory Board, US regulatory agents and experts in pharmacokinetic (PK) studies. The development strategy is intended to accelerate registration of SUD-001 by utilising a PK approach thus not requiring clinical efficacy studies in migraine patients. Instead, SUDA’s two-part pivotal study will assess the PK parameters of SUD-001 (eg: the plasma concentration of
sumatriptan) compared to the currently approved formulations of sumatriptan in approximately 70 healthy subjects.

Mr Stephen J Carter, CEO commented: “We are delighted that the FDA has broadly accepted our development plan, which is designed to support the submission of a New Drug Application in the USA by the end of 2017. Under this plan, we expect to save significant time and capital by avoiding the need to conduct costly efficacy studies prior to registration of SUD-001 in the USA. The FDA’s constructive responses keep us on track to commence our pivotal PK study of SUD-001 in early CY2016 and, importantly, will strengthen our negotiating position with prospective pharmaceutical partners in the USA, Europe and elsewhere by quantifying the cost and time to get to market.”

To read the full announcement, please click here.