SUDA Pharmaceuticals receives TGA approval for ZolpiMist adult insomnia treatment

Perth-based SUDA Pharmaceuticals (ASX: SUD) has received approval from the Therapeutic Goods Administration for its ZolpiMist oral spray to be used in the treatment of short-term adult insomnia.

The company has also been approved as a supplemental active pharmaceutical ingredient (API) supplier and final product manufacturer, allowing it to supply ZolpiMist at a more competitive price and potentially allow it to target additional territories.

The API will be sourced from a global generics manufacturer and ZolpiMist will be made and packaged by the Australian subsidiary of a separate global manufacturer of over-the-counter and generic prescription pharmaceuticals.

The TGA submission was a combined effort by SUDA’s technical team and regulatory consultant Pharma To Market.

SUDA chief executive officer Dr Michael Baker said ZolpiMist would now be included on the Australian Register of Therapeutic Goods for commercial development and supply.

“Obtaining this approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist,” he said.

“We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future.”

ZolpiMist

ZolpiMist is a cherry-flavoured oro-mucosal spray formulation of zolpidem tartrate – a non-benzodiazepine marketed as tablets under the brand name of Ambien or Stilnox and prescribed for the short-term treatment of insomnia characterised by difficulties with sleep initiation.

It provides an easy-to-use alternative route of administration by delivering a therapeutic dose with one or two sprays into the mouth.

Unlike conventional tablets, it can be used without water, making it an option for those who have difficulty swallowing or those suffering from gastrointestinal disorders which restrict the absorption of drugs via the gastrointestinal mucosa.

Clinical study results in mid-2019 demonstrated that ZolpiMist can deliver more rapid sleep onset compared to the tablet form of zolpidem based on efficacy parameters and pharmacokinetic findings.

Commercial partners

SUDA has been working with partner companies for the commercialisation of ZolpiMist since 2016, when it signed its first licencing agreement with Chinese pharmaceutical company Eddingpharm (Asia) Macao Commercial Offshore for sales of the product into that market.

The following year, SUDA entered into an exclusive licence agreement with Teva Pharmaceuticals International GmbH for supply of ZolpiMist into Brazil, Mexico and Chile, and an 18-month option for Argentina, Israel and Australia.

In 2018, SUDA signed a 12-month agreement with Mitsubishi Tanabe Pharma Singapore which will allow ZolpiMist to be sold in Philippines, Malaysia and Singapore with options for Thailand, Indonesia, Vietnam, Myanmar, Cambodia, Laos and Brunei.

Earlier this year, an additional agreement was signed to include South Korea for a term of 10 years from first commercial sale.

Unsatisfactory sleep

Insomnia can be defined a level of unsatisfactory sleep which affects areas of a person’s daytime functionality such as concentration, energy levels, memory and mood.

All of these symptoms eventually result in a reduced quality of life and can also impact a person’s work life by decreasing productivity and increasing absenteeism.

Research shows almost 90% of Australians suffer from sleeping issues, with around 30% experiencing severe sleeping disorders and 5% experiencing chronic insomnia.