SUDA granted meeting with UK MHRA for approval of ZolpiMist™

SUDA LTD (ASX: SUD), a leader in oro-mucosal drug delivery, today announces that that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted SUDA a meeting on 21 June 2017 to discuss the proposed plan for registration of SUDA’s novel ZolpiMist™ oral spray of zolpidem tartrate to treat insomnia in the UK and European Union.

KEY TAKEAWAYS:

• SUDA is seeking advice on the suitability of its regulatory strategy which is to file for approval of ZolpiMist in Europe based on the data that successfully resulted in the product’s US FDA approval.
• The proposed regulatory dossier is intended to support a marketing authorisation application to either the MHRA or the European Medicines Agency.
• SUDA will be seeking advice from the MHRA on the acceptability of the excipients used in the ZolpiMist oral spray formulation which are all listed in the US pharmacopeia.

Mr Stephen Carter, SUDA’s CEO and Managing Director, commented: “It is estimated that about 100 million people suffer from some sort of insomnia in the EU (source: EFPIA). There remains a significant unmet need for new treatment options, particularly for patients that want rapid onset of sleep, have problems swallowing tablets or have gastrointestinal complications. For these patients, ZolpiMist offers an attractive alternative with rapid absorption of the drug through the oral mucosa. We look forward to the feedback from the MHRA and to bringing ZolpiMist to market in this key territory.”

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