All the marketed Triptans will become generic by 2015, while Sumatriptan is already generic in several countries and Astra Zeneca Zomig® (Zolmitriptan) patent protection will expire in 2012 in Europe, 2013 in US and 2014 in Japan. Although some new drugs currently in the R&D pipeline will enter the market soon, there is no expectation that Triptans will lose their leading position in treating acute migraine attacks between now and 2017. On such basis, the availability of a value added, innovative product within the Triptans range that can ensure additional benefits for patients and protection against the price fight that is expected to happen could be a key winning factor in the migraine market.
Considering that there is no evidence of any clear clinical superiority among various Triptans, the current competitive trend has been toward dosage forms providing clear differentiation such as Oral Dispersible Tablets (ODTs) or more recently Nasal Sprays..
Zolmitripan Oral Dispersible Film (ODF) strip uses the proprietary Rapidfilm™ technology (for the European product) and the PharmFilm® technology (for the US market) which are novel, nonmucoadhesive, fast dissolving oral dosage forms that provide:
> Quick onset of action comparable to other novel oral formulations (ODTs)
> T-max plasma concentration achieved in 1.5 hr. vs. 4hr. with the nasal spray.
> More cost effective and with better compliance compared to nasal sprays that reports a high incidence of side effects like bad taste (20-25%), nose and throat discomfort (more than 6%) and occurrence of aftertaste (possible trigger of nausea)
> Better compliance compared to other oral formulations, not requiring any intake of water or having to swallow pills (possible trigger of nausea)
Products developed using Orodispersible Film technology (ODF) are considered by the FDA as a different dosage form than tablets and ODTs and therefore products developed with this drug delivery technology are not AB rateable or substitutable by ODTs. Zolmitriptan ODF will be available in both 2,5mg and 5mg dosages.
The 2,5mg Zomitriptan ODF could also possibly be marketed as OTC product, assuming a Rx to OTC switch of the corresponding strength from the originator.
The registration procedure of Zolmitriptan ODF started on November 8th, 2010 as decentralized procedure (DCP) with Germany as Reference Member State and 14 Concerned Member States ( Austria, Belgium, Denmark, Finland, France, Ireland, Italy, The Netherlands, Norway, Poland, Portugal, Spain, Sweden and United Kingdom). The DCP procedure is expected to be completed by the second quarter of 2012.
In-vivo pivotal bioequivalence study in fasting condition of test product Zolmitriptan ODF versus the reference product Ascotop® Schmelztabletten (Zolmitriptan ODT) marketed in Germany has been performed on 28 volunteers and the report with the results is available . A single study should be enough to register the two strengths (2.5 mg and 5 mg) due to linearity of the pharmacokinetic profile of Zolmitriptan.
The registration strategy for US is to apply under a 505(b)(2) procedure. The US Dossier will include BE studies vs. the US marketed reference in either fast and fed conditions.
Consistent Patent Estate (some granted and some still pending) claiming the platform Rapidfilm™ technology as well as specific formulation developments,
Licensing and Supply Agreement. The product is available for licensing in Europe, USA and other territories
Mr Aldo Donati
VP Business Development & Licensing
APR is a private, independent, integrated Healhcare Company focused on Delivering, Funding and Supporting Innovation in Healthcare.View profile
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