Ipsen announces late-breaking data from first head-to-head study comparing Dysport and Botox in adults with upper limb spasticity

• Phase IV head-to-head, double-blind trial comparing safety and efficacy met its primary and secondary endpoints
• The DIRECTION trial results show the safety profile for Dysport (abobotulinumtoxinA) was non-inferior to Botox (onabotulinumtoxinA) in adult patients with upper limb spasticity
• Patients treated with Dysport in the DIRECTION trial achieved a longer duration of response than patients treated with Botox
• Data will be presented at a late-breaking session at the ISPRM congress¹

PARIS, FRANCE – 19 MAY 2026 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today results from the only prospective, head-to-head Phase IV DIRECTION trial comparing Dysport (abobotulinumtoxinA) to Botox (onabotulinumtoxinA) in adults living with upper limb spasticity (ULS)¹ will be presented as a late-breaking presentation at the International Society of Physical and Rehabilitation Medicine (ISPRM) world congress in Vancouver on May 19, 2026. The trial showed that patients treated with Dysport had a non-inferior safety profile to Botox and achieved longer-lasting symptom control (based on a pre-specified 80% confidence interval)¹.

The DIRECTION trial addresses decades-long evidence gaps by delivering the first head-to-head, double-blind, comparative data between Dysport and Botox in adult spasticity. More broadly, these findings reinforce published real-world experience demonstrating that Dysport delivers durable results for patients with ULS in routine practice².

“Ipsen is committed to generating robust clinical evidence that supports scientific understanding and real-world practice. In spasticity, the durability of treatment response plays a critical role in patients’ function, mobility and quality of life,” said Sandra Silvestri, PhD, MD, Chief Medical Officer, Ipsen. “The DIRECTION data provides further support that Dysport can delay breakthrough symptoms with a well-established safety profile.”

For the primary endpoint of the trial, Dysport demonstrated non-inferiority compared with Botox with a treatment-emergent adverse event rate of 20.3% vs 23.0%, respectively (adjusted difference (aboBoNT-A – onaBoNT-A) was −2.7% (80%CI: −6.2%, 0.9%)¹. The results support the well-established safety profiles of these treatments.

In addition, the secondary efficacy endpoint was met: patients treated with Dysport experienced a longer duration of effect compared with those treated with Botox (14.2 vs 13.8 weeks, respectively; adjusted difference favoring Dysport (80%CI: 0.2, 5.9) with a pre-specified significance threshold for statistical significance (p=0.17; significance threshold, p=0.20).

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