Ipsen (IPN.PA) Announces Clinical Results Of Dysport® Next Generation (DNG) And Its Intent To File The First Ready-To-Use Liquid Toxin A In Europe And ROW1
2/5/2014 5:05:48 AM
PARIS--(BUSINESS WIRE)--Regulatory News: Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) today announced the results of the international Phase III clinical trial of Dysport® Next Generation (DNG) in cervical dystonia and the results of the European Phase II clinical trial of DNG in glabellar lines. In the light of these results, Ipsen announces its intention to file the first ready-to-use liquid toxin A in Europe and in the Rest of the World1 (ROW). Pr. Werner Poewe (International Principal Investigator of the study) said: “This is the very first international Phase III trial to show that a liquid toxin A is safe and efficacious. Although the statistical non-inferiority criterion between DNG and Dysport® was not formally met in the Double Blind Phase of the trial, this is unlikely to reflect clinical meaningful differences between the two formulations. In addition, the Open Label Long Term data show sustained and robust efficacy of DNG with a good safety profile. These important results will help the medical community to assess the place of a ready-to-use liquid toxin A in the treatment options for patients suffering from cervical dystonia.”
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