- SUDA Pharmaceuticals (SUD) has its lead product for short-term insomnia, ZolpiMist, approved by the Chile Ministry of Health
- SUDA’s partner, Teva Pharmaceuticals, submitted the application to the Chilean authority in May 2021 and was granted approval six months sooner than expected
- SUDA says the approval allows it to supply the product at a more competitive price and enables the product to be commercialised and distributed within Chile
- SUDA Pharmaceuticals was up 2.04 per cent, trading at 5 cents at 2:20 pm AEDT
SUDA Pharmaceuticals (SUD) has had its lead product, ZolpiMist, for short-term insomnia in adults, approved by the Chile Ministry of Health.
ZolpiMist is a first-in-class oral spray of zolpidem tartrate, which has been previously approved by the Food and Drug Administration (FDA) in the US and the Therapeutic Goods Administration (TGA) in Australia, and is currently marketed in the US.
SUDA’s partner, Teva Pharmaceuticals, submitted a marketing authorisation application (MAA) to the Chilean authority in May 2021. This marks the first of Teva’s territories to achieve approval.
The company also noted approval was granted significantly sooner than the expected date of April 2022.
“Obtaining the approval indicates the calibre of SUDA’s team as well as that of our partner, Teva Pharmaceuticals and is a key benefit to our partners for ZolpiMist,” said Dr Michael Baker, Chief Executive Officer & Managing Director.
The company said the improved supply chain allowed SUDA to supply the product at a more competitive price.
With the Chilean tick of approval, ZolpiMist can be commercialised and distributed within Chile, and will support regulatory approvals from partners, thanks to its international Good Manufacturing Practice.
“We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future,” Dr Baker said.
SUDA Pharmaceuticals was up 2.04 per cent, trading at 5 cents at 2:20 pm AEDT.