SUDA gains regulatory approval for sale of insomnia treatment spray

Australians suffering from insomnia could soon have relief from the disorder with SUDA Pharmaceuticals (ASX: SUD) gaining approval from the Therapeutics Goods Administration (TGA) for the sale of their ZolpiMist spray as a treatment for short-term insomnia. 

The regulatory approval enables ZolpiMist to be sold in Australia and will assist their strategic partners in other regions to gain similar approvals as the key milestone in the commercialisation of the product. 

“The TGA submission was a combined effort by SUDA’s technical team as well as our regulatory consultant, Pharma To Market”, said SUDA Pharmaceuticals CEO, Dr Michael Baker. 

“Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist. We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future.” 

Given via oro-mucosal delivery, ZolpiMist is a non-invasive treatment which can enable faster onset with lower dosage compared to oral consumables. 

While Australia represents a valuable market for SUDA, the company has rights to ZolpiMist everywhere outside of North America and have sub-licensed other partners for regulation, marketing and distribution in Mexico, Chile, Brazil, Singapore, Malaysia, the Philippines and Korea. 

The product has been approved for sale in the United States since 2008 however has been marketed in a limited capacity due to congestion in the world’s largest healthcare market. 

TGA approval coincidentally comes following SUDA’s announcement of a capital raise, seeking to raise $3.56m from shareholders as an Entitlement Offer at $0.025 per share. 

According to the American Academy of Sleep Medicine, 30% of adults experience symptoms of insomnia and about 10% have insomnia that is severe enough to cause daytime disruption. 

Following news of the TGA approval, the market responded exceptionally well with SUD shares reaching a high of $0.082 in early morning trade, a rise of 203% on their previous $0.027 close.