Allergan has received a positive opinion for Botox (Botulinum Toxin Type A) from the Irish Medicines Board serving as reference member state in the mutual recognition procedure (MRP) for treatment of focal spasticity of the ankle in adult post-stroke patients.
The positive opinion from the Irish Medicines Board for Botox is an important step towards securing national licenses in the 14 European countries involved in the MRP and marks a key milestone in bringing this treatment to stroke survivors across Europe suffering from lower limb spasticity.
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Irish Medicines Board’s positive opinion for Botox is based on a multi-centre Phase III study evaluating the safety and efficacy of the toxin in patients with post-stroke lower limb spasticity affecting the ankle.
A total of 120 patients have been randomised to a single treatment of Botulinum toxin type A (300 units) or placebo in the double-blind, placebo-controlled Phase III study.
According to Allergan, the Phase III study has showed that patients treated with Botulinum toxin type A achieved a significant improvement in muscle tone compared with those treated with placebo.
Compared with placebo, significant improvements were also observed in the study at the individual post-treatment visits at weeks four, six and eight.
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By GlobalDataTreatment with Botox was associated with a significant improvement in the investigator’s clinical global impression of functional disability compared to placebo at weeks four, six and eight. In this study, a consistent response has been observed with re-treatment.
Allergan EAME president Paul Navarre said: "This decision underscores Allergan’s long-standing commitment to innovation in botulinum toxin science and our significant R&D investments. We remain committed to supporting doctors and their patients to better manage this potentially debilitating condition."
Allergan said that Botox treatment was generally well-tolerated although it should only be used for treatment of post-stroke lower limb spasticity following evaluation by health care professionals experienced in the management of the rehabilitation of post-stroke patients.
Image: 3D ribbon model of botulinum neurotoxin serotype A. Photo: courtesy of Ayacop.
