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news.US-based Allergan has obtained 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 the treatment of focal spasticity of the ankle in adult post stroke patients.
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According to Allergan, the Irish Medicines Board’s positive opinion 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 who are suffering from lower limb spasticity.
Allergan EAME president Paul Navarre noted that the company is pleased that Botox has received the green light for the treatment of lower limb spasticity associated with stroke in adults.
"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," Navarre added.
The Irish Medicines Board has issued positive opinion for Botox based on a multi-center Phase III study evaluating the safety and efficacy of the toxin in patients with post-stroke lower limb spasticity affecting the ankle.
The double-blind, placebo-controlled Phase III study has randomized a total of 120 patients to a single treatment of Allergan’s Botulinum toxin type A (300 units) or placebo.
The Phase III study has demonstrated that patients treated with Botulinum toxin type A achieved a significant improvement in muscle tone compared to those treated with placebo. Compared to placebo, significant improvements were also observed at the individual post-treatment visits at weeks four, six and eight.
In addition, treatment 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. A consistent response was observed with re-treatment.
Allergan said that Botox treatment was generally well tolerated although it should only be used for the 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