Suda (ASX: SUD) has received a written response from the US FDA regarding the development plan for its SUD-001 sumatriptan oral spray for the treatment of migraine.
SUDA submitted a Type C meeting briefing package to the FDA on 13 June containing details of the proposed pivotal study of SUD-001 and other activities intended to support a New Drug Application in the US.
According to the company, the FDA acknowledged its proposed development strategy and requested only minor justifications to the study design. The FDA had no comments regarding its plans for chemistry, manufacturing, controls and non-clinical studies of SUD-001, but requested the company submit a paediatric study plan in migraineurs aged 6-17 years who could benefit from the therapy.
"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," said the company.
"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."
"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," said CEO Stephen Carter. "Under this plan, we expected to save significant time and capital by avoiding the need to conduct costly efficacy studies prior to registration of SUD-001 in the USA."
He added, "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."