<div id="readability-page-1"><div> (RTTNews) - Ipsen (IPN) announced late-breaking results from the first prospective, head-to-head study comparing Dysport and Botox in adults with upper limb spasticity, with the Phase IV DIRECTION trial meeting both its primary and secondary endpoints. Upper limb spasticity is a neurological condition that causes involuntary muscle stiffness and can significantly affect mobility, daily function, and quality of life. Botulinum toxin type A injections are considered a first-line treatment, but many patients experience a return of symptoms before their next scheduled injection. In the DIRECTION trial, Ipsen evaluated Dysport (abobotulinumtoxinA) against Botox (onabotulinumtoxinA) in a randomized, double-blind crossover study involving 464 adults across 72 sites in the U.S., France, and Canada. Each participant received one treatment cycle with each therapy using standardized, instrument-guided injection techniques to ensure fair comparison. For the primary endpoint, Dysport demonstrated non-inferiority in safety compared with Botox, with treatment-emergent adverse event rate of 20.3% versus 23.0%, respectively. Ipsen noted that these results reinforce the well-established safety profiles of both treatments. For the key secondary endpoint, patients treated with Dysport experienced a longer duration of effect- 14.2 weeks versus 13.8 weeks for Botox- based on a pre-specified 80% confidence interval. Evidence of longer duration was consistent across most demographic and clinical subgroups. This is meaningful, as published research shows that more than 80% of patients experience breakthrough symptoms between injection cycles and over 70% express a need for longer-lasting treatment. Ipsen's CMO Sandra Silvestri, said the findings support Dysports's ability to delay breakthrough symptoms while maintaining a well-established safety profile. Principal Investigator Dr. Alberto Esquenazi added that the study provides the first comparative evidence distinguishing the performance of two widely used botulinum toxin treatments in spasticity. Dysport, an injectable botulinum neurotoxin type A product, has more than 30 years of clinical experience and over 18 million treatment-years globally, with marketing authorization in approximately 90 countries. Ipsen stated that the DIRECTION trial fills a decades-long evidence gap delivering the first rigorously controlled, double-blind comparison between Dysport and Botox in adult spasticity. The data were presented as a late-breaking session at the International Society of Physical and Rehabilitation Medicine (ISPRM) World congress in Vancouver on May 19, 2026. IPN has traded between EUR 100 and EUR 173.50 over the past year. The stock is currently trading at EUR 158.10, up 0.32%. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. </div></div>

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Ipsen announced results from the Phase IV DIRECTION trial, the first head-to-head study comparing Dysport and Botox for upper limb spasticity. Dysport showed non-inferiority in safety and a longer duration of effect (14.2 weeks vs. 13.8 weeks). The trial involved 464 adults across 72 sites and addressed a significant need for longer-lasting treatment. The findings were presented at the ISPRM World Congress in Vancouver. Ipsen's stock is currently trading at EUR 158.10, up 0.32%.

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Ipsen Reports First Head-to-Head Data Showing Dysport Provides Longer Symptom Control Than Botox