ZIM Labs gets marketing authorisation for Rizatriptan orally dissolving film in Portugal

Approved

ZIM Laboratories announced that Infarmed has granted marketing authorisation for its innovative product, Rizatriptan Orally Dissolving Film in Portugal, Europe to its wholly-owned European subsidiary.

Rizatriptan is widely used for relief from Migraine attacks. Migraine was ranked as the fifth leading cause of years lived with disability (YLD) in Western Europe and the sixth leading cause of YLD in Central and Eastern Europe in the Global Burden of Disease. The economic burden of migraine is significant. Different European studies have estimated the cost of at €18 billion to €27 billion depending on study setting and design. The majority of all migraine related costs (77–93%) are indirect costs attributed primarily to work productivity losses. Migraine is often associated with symptoms such as nausea, vomiting, phonophobia (sensitivity to sound), and photophobia (sensitivity to light) and because of the severity of the symptoms, it needs medication that can be given to a patient without making these symptoms worse and that also produces a faster onset of action.

A company statement informed, “Rizatriptan Orally Dissolving Film is a product developed using Thinoral technology which yields instantly wettable, rapidly dissolving, and stable films. The fast-dissolving feature provides a potentially faster onset of action, and the flexible nature of the film dosage form allows for convenience in handling and administration. As the presently available product in the market is a mouth dissolving tablet that is extremely fragile, Zim’s product offering is likely to provide a significant advantage to patients in terms of portability as well as faster action. Rizatriptan orally dissolving film by virtue of its convenience in administration ensures treatment adherence and will help to reduce the economic burden. The global market of Rizatriptan is about $200 million.”

Commenting on the granting of the marketing authorisation, Dr Anwar Daud, MD of Zim Laboratories said, “The approval of this novel orally dissolving film is further evidence of Zim Lab’s determination to become the preferred partner for our clients who are seeking innovative new therapies to treat unmet needs for the patients and physicians.”

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