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UK firm files for cannabis-based MS drug approval
05 Sep 2006
Clinical Research
GW Pharmaceuticals has filed for regulatory approval of Sativex, a cannabinoid spray designed to reduce spasticity in patients with multiple sclerosis (MS).
The filings were in Denmark, the Netherlands, Spain and the UK, and were made under the 'decentralised procedure' whereby the UK acts as Reference Member State in consultation with the other countries.
The submission is backed up by two pivotal phase III trials and two supportive trials, and represents clinical data obtained from 700 patients suffering MS spasticity, whereby muscles suddenly spasm or seize up.
Dr Stephen Wright, R&D director at GW, said: "The conclusion of GW and its marketing partners, taking into account the views of the regulators, as well as the unmet needs of this target patient group, is that this body of data warrants serious regulatory evaluation."
Dr Geoffrey Guy, GW's executive chairman, added: "Beyond the filing today in MS spasticity, the phase III clinical trials programme continues and will provide further sets of clinical data to support additional regulatory filings in separate indications."
Subject to its approval, the marketing of Sativex will be lead by Bayer HealthCare in the UK and Almirall in the other European countries.
GW is an Aim-listed UK company, operating from Porton Down in Wiltshire.
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