Out-licensing

2,5mg and 5mg Zolmitriptan Rapidfilm® uses oral dissolving film strip technology without need of water.

The drug acts peripherally and inhibits the dilation and inflammation of the cranial vessels whilst also having a nociceptive action in the brainstem nuclei.

Labtec is out-licensing Zolmitriptan RapidFilm^®, a new innovative oral formulation generic to Zomig-ZMT^® ODT  - Approval granted !

Zolmitriptan has a dual mechanism of action. Zolmitriptan has beneficial effects on nausea and vomiting as the drug binds to the tractus solitarius nucleus, the center for control of vomiting. The Zolmitriptan oral fast dissolving film (ODF) is especially designed for higher compliance on migraine patients suffering from nausea and vomiting. 

The product uses Labtec’s proprietary film strip technology platform which is a novel, non-mucoadhesive, fast dissolving oral dosage form, based on a water soluble polymer. Placed on the top of the tongue, the film dissolves within seconds (water is not needed), promoting a gastro- intestinal absorption comparable to immediate release oral solid dosage forms. Another Rapidfilm^® formulation with the active ingredient (Ondansetron) was just approved by the EU Authorities for marketing. It is the first Rx oral dispersible film approved worldwide.

Zolmitriptan Rapidfilm^® has been developed as an oral dispersible film in both dosages of Zomig (2.5 and 5 mg). The product qualifies for an Rx-OTC switch.
Zolmitriptan Rapidfilm^® offers competitive advantages versus Zomig tablets and Zomig-ZMT^® as well as Spray:

-  higher compliance vs Zomig Tablets: swallowing is easier and water is not needed

-  higher compliance vs Zomig-ZMT^®: easier to be handled, stored and taken away

-  higher compliance vs. Spray; no residual aftertaste

The absence of Aspartame in the formulation makes the product safe also for phenylketonuric patients, for whom the use of Zomig-ZMT^® is contraindicated.

The European approval (via DCP) has been granted. The DCP was concluded in February 2012 in 15 countries.

Registered

Consistent Patent Estate (some granted and some still pending) claiming the platform Rapidfilm™ technology as well as specific formulation developments.

Labtec submitted the EU-eCTD Dossier in 12/2010 in Germany via DCP.

The European approval was granted in February 2012!

Labtec is currently looking to partner the product worldwide or in selected regions.

not disclosed