News and Announcements
SUDA’s Licensee Lodges Application for Short-Term Treatment of Insomnia
- Published December 11, 2017 12:00AM UTC
- Publisher Wholesale Investor
- Categories Company Updates
KEY TAKEAWAYS:
- SUDA’s licensee Teva started the submission for the ZolpiMist approval, the promising drug of choice for short-term treatment of insomnia due to its enhanced distinctive qualities.
- A study conducted revealed a high prevalence rate of insomnia in target territories.
- It is an estimated twelve months period review for the initial application.
SUDA Pharmaceuticals Limited (ASX: SUD) the conveying trendsetter of oro-mucosal medications enunciates one of its licensees, namely Teva Pharmaceutical Industries Limited has yielded its initial Marketing Authorization Application for the product ZolpiMist.
As noted last July 2017, the two companies began a license and agreement of supplies pertaining to the aforesaid product catering its availability in a selection of various nations. ZolpiMist is the promising drug of choice for short-term treatment of insomnia due to its enhanced distinctive qualities. It effectively acts as a sedative and hypnotic targeting unbalanced brain chemicals in patients with sleep disorders.
According to the recent research study conducted in the scope of the participating four biggest metropolitan areas in the validated territory focusing on adult participants resulted to a pointed conclusion regarding insomnia. The occurrence of insomnia determined an estimated 35% with the inclusion of 15% of the adult participants consuming sedatives. Hence the findings pertained an increased frequency compared to other concentrated groups globally.
“We have been working hard with our partner Teva to expedite the submission of the First Marketing Authorisation Application for ZolpiMist. We are delighted that Teva has maintained its timetable of filing within five months from signing the last licensing deal. There is a high prevalence of insomnia in the licensed territory and ZolpiMist offers patients a valuable treatment option with unique advantages compared to standard-of-care tablets” stated by Mr. Stephen Carter, CEO of SUDA.
The procedure for the regulation of the review is considered to have a duration of twelve month period in conjunction to the approbation of ZolpiMist as scheduled by 2018 respectively. The acceptance of ZolpiMist will commence a significant point of payment to SUDA. As specifically propounded with Teva regarding the terms of the agreement.
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