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Ipsen Announces Dysport is the first botulinum toxin to achieve positive topline Phase III results in both episodic and chronic migraine

chronic migraine

French healthcare company Ipsen announced major news today regarding a new migraine prevention treatment. The company shared positive topline results from its Phase III BEOND clinical program. This extensive trial evaluated Dysport for adult patients. Specifically, it targeted people suffering from frequent headaches. Both the E-BEOND and C-BEOND trials successfully met their primary goals. Ultimately, Dysport significantly reduced monthly migraine days compared to a placebo.

Consequently, these results mark a massive medical milestone. The E-BEOND data represents a historic achievement. This is the first Phase III clinical trial where a botulinum toxin proved effective for episodic migraine. Additionally, the combined data delivers another major first. The BEOND program proves that a single botulinum toxin can prevent both episodic and chronic migraine. Patients tolerated the medication exceptionally well throughout both studies. Furthermore, researchers found no new or unexpected safety concerns during the trials. The safety profile perfectly matches the established safety records of Dysport.

“These results represent a significant advance in the development of botulinum toxin therapies for migraine,” said Christelle Huguet, PhD, EVP and Global Head of R&D. “BEOND is the first Phase III program to demonstrate efficacy of a botulinum toxin in both episodic and chronic migraine. Together, these findings position Dysport as a potential first-in-class treatment for a broad migraine population.”

Addressing a Widespread Neurological Challenge

Migraine remains a widespread neurological condition. Millions of people face an urgent, unmet medical need every day. This condition severely impacts daily life. It disrupts a person’s ability to maintain regular work hours. Likewise, it hurts their ability to enjoy social plans. Doctors define episodic migraine as experiencing up to 14 headache days per month. At least six of those must be actual migraine days. This group represents a huge patient population. Contrastingly, chronic migraine patients suffer from headaches 15 or more days each month. Therefore, this new migraine prevention treatment offers vital hope.

“These Phase III topline results position Dysport as the first botulinum toxin to demonstrate efficacy for both episodic and chronic migraine prevention, supporting an advance in treatment options for patients,” said Dr. Cristina Tassorelli, MD, Professor and Chair of Neurology and Director of the Department of Brain and Behavioral Sciences at the University of Pavia, based in Pavia, Italy and Principal Investigator for the C-BEOND trial.

This innovative migraine prevention treatment could transform standard healthcare options. Current preventative choices remain quite limited for many individuals. Fortunately, these clinical developments signal a bright future. Ipsen will present detailed data from the program at an upcoming scientific congress.

“Preventive treatment options for episodic migraine remain limited. These clinical trial results are encouraging because they suggest a potential new preventative therapy that, if approved, may benefit a broad group of patients,” said Dr. Jessica Ailani MD, Clinical Professor of neurology at MedStar’s Georgetown University Hospital and Director of the MedStar Georgetown Headache Center, based near Washington DC, and Principal Investigator for the E-BEOND trial.

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News Source: GlobeNewswire.com